Correlated Drug Terms (114)

---

	Name (Synonyms)	Correlation
drug3485	survey work Wiki	0.22
drug465	Breath Biopsy face masks with removable filters and fitted PVA strip Wiki	0.22
drug452	Blood sampling Wiki	0.18
drug1176	Generalized Anxiety Disorder-7 (GAD 7) Wiki	0.15
drug800	Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms Wiki	0.15
drug3254	e-Psychotherapy Wiki	0.15
drug495	C3+ Holter Monitor Wiki	0.15
drug1711	Meditation app usage Wiki	0.15
drug3230	computerized cognitive training (CCT) Wiki	0.15
drug3163	a survey Wiki	0.15
drug436	Blood donation from convalescent donor Wiki	0.15
drug343	BI 764198 Wiki	0.15
drug699	Cognitive Training Wiki	0.15
drug2198	Post Traumatic Stress Disorder questionnaire (PTSD-8) Wiki	0.15
drug1975	Online Questionnaire Wiki	0.15
drug418	Biological: mRNA-1273: 100 mcg Wiki	0.15
drug2064	Patient Health Questionnaire (PHQ-9) Wiki	0.15
drug1528	Kundalini Yoga and Anxiety Reduction Training Wiki	0.15
drug975	Effortful Control Camp Wiki	0.15
drug2964	Trauma-informed yoga video recording Wiki	0.15
drug896	Digital intervention Wiki	0.15
drug478	Bromhexine 8 MG Wiki	0.15
drug2109	Physical Exam Wiki	0.15
drug1413	Information-only intervention Wiki	0.15
drug3020	Urine Test Wiki	0.15
drug342	BI 706321 Wiki	0.15
drug422	Biosensor Wiki	0.15
drug3081	Virtual-Care Cognitive Behavioural Therapy Wiki	0.15
drug432	Blood and derivatives. Wiki	0.15
drug494	C21 Wiki	0.15
drug732	Confinement and Communication During the COVID-19 Pandemic Wiki	0.15
drug416	Biological/Vaccine: Angiotensin peptide (1-7) derived plasma Wiki	0.15
drug425	Biospecimen collection Wiki	0.15
drug742	Control Blend Wiki	0.15
drug236	Anxiety Reduction Training Wiki	0.15
drug1042	Experiences in Close Relationship Scale questionnaire (ECR-S) Wiki	0.15
drug1710	Meditation and Anxiety Reduction Training Wiki	0.15
drug3040	VRC-SRSDNA015-00-VP Wiki	0.15
drug1725	Mental Health questionnaire Wiki	0.15
drug1099	Feeling Good Digital App Wiki	0.15
drug450	Blood samples (collection of 5 mL of blood in a dry tube) Wiki	0.15
drug288	Attention Bias Modification (ABM) Wiki	0.15
drug446	Blood sample for serological test Wiki	0.15
drug684	Clinical interview Wiki	0.15
drug438	Blood for anti-drug antibody (ADA) Wiki	0.15
drug433	Blood collection Wiki	0.15
drug434	Blood collection on admission and longitudinally Wiki	0.15
drug440	Blood for research purposes Wiki	0.15
drug3241	covid-19 positive pregnant women Wiki	0.15
drug503	CCP Wiki	0.15
drug370	Background questionnaire Wiki	0.15
drug1844	Nasopharyngeal, oropharyngeal, or saliva swab Wiki	0.15
drug442	Blood plasma Wiki	0.15
drug1207	HADS Wiki	0.15
drug2612	Serum tube collection Wiki	0.15
drug2319	Questionnaire, phone call Wiki	0.15
drug2735	Standardised questionnaires Wiki	0.15
drug1023	Essential Oil Blend Wiki	0.15
drug1050	Exposure Therapy Wiki	0.15
drug2973	Trivia Training Wiki	0.15
drug499	CAP-1002 Allogeneic Cardiosphere-Derived Cells Wiki	0.15
drug3106	Waitlist Wiki	0.15
drug2846	Telehealth CBT Wiki	0.15
drug430	Blood Test Wiki	0.15
drug414	Biological sampling Wiki	0.15
drug3395	oropharyngeal swabs Wiki	0.15
drug697	Cognitive Behavioural Group Therapy for Perinatal Anxiety Wiki	0.15
drug510	CGB-S-100 Wiki	0.15
drug439	Blood for pharmacokinetic samples Wiki	0.15
drug2911	Throat swab Wiki	0.15
drug350	BLD-2660 Wiki	0.15
drug415	Biological test Wiki	0.15
drug435	Blood collection on their first consultation and 10 to 14 days later Wiki	0.15
drug423	Biosensors Wiki	0.15
drug2777	Survey administration Wiki	0.15
drug1062	Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki	0.15
drug467	Breath sample Wiki	0.15
drug419	Biological: mRNA-1273: 50 mcg Wiki	0.15
drug3041	Vaccine Wiki	0.15
drug2052	Pandemic control measures Wiki	0.15
drug798	Cross Sectional study using scientifically validated psychometric Scales Wiki	0.15
drug2268	Psychoeducational intervention Wiki	0.15
drug1767	MinnRAP Peer Support Program Wiki	0.15
drug464	Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application Wiki	0.15
drug429	Blood D-dimer assay Wiki	0.15
drug1456	Intervention App Wiki	0.15
drug2411	Relaxation Therapy Wiki	0.15
drug2258	Prospective study across two time-points examining the impact of viral mitigation protocols on mental health Wiki	0.15
drug1827	NT-I7 Wiki	0.15
drug1397	Impact of COVID-19 questionnaire Wiki	0.15
drug701	Cognitive behavioral therapy (CBT) Wiki	0.15
drug417	Biological: COVID-19 convalescent plasma Wiki	0.15
drug463	Brazilian Green Propolis Extract (EPP-AF) Wiki	0.15
drug730	Computer task questionnaires Wiki	0.15
drug1843	Nasopharyngeal swabs Wiki	0.15
drug443	Blood sample Wiki	0.15
drug453	Blood test Wiki	0.11
drug449	Blood samples Wiki	0.11
drug696	Cognitive Behavioral Therapy Wiki	0.11
drug485	Bucillamine Wiki	0.11
drug437	Blood draw Wiki	0.11
drug424	Biospecimen Collection Wiki	0.09
drug1690	Matching placebo Wiki	0.09
drug2259	Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki	0.09
drug547	COVID-19 RT-PCR Wiki	0.09
drug1977	Online Survey Wiki	0.08
drug1841	Nasopharyngeal swab Wiki	0.08
drug2551	Saliva collection Wiki	0.07
drug2312	Questionnaire Administration Wiki	0.06
drug2692	Standard care Wiki	0.05
drug2774	Survey Wiki	0.05
drug1301	Hydroxychloroquine Sulfate Wiki	0.04
drug2122	Placebo Wiki	0.04
drug2698	Standard of Care Wiki	0.03

Correlated MeSH Terms (27)

---

	Name (Synonyms)	Correlation
D001010	Anxiety, Separation NIH	0.22
D000072861	Phobia, Social NIH	0.22
D000379	Agoraphobia NIH	0.22
D003866	Depressive Disorder NIH	0.21
D004194	Disease NIH	0.19
D016584	Panic Disorder NIH	0.18
D015775	Fractures, Stress NIH	0.15
D001248	Asthenopia NIH	0.15
D009155	Mutism NIH	0.15
D000067292	Alcohol Drinking in College NIH	0.15
D003863	Depression, NIH	0.15
D040921	Stress Disorders, Traumatic NIH	0.12
D013313	Stress Disorders, Post-Traumatic NIH	0.11
D009771	Obsessive-Compulsive Disorder NIH	0.11
D019964	Mood Disorders NIH	0.11
D013180	Sprains and Strains NIH	0.11
D003193	Compulsive Personality Disorder NIH	0.11
D000068376	Compassion Fatigue NIH	0.11
D010698	Phobic Disorders NIH	0.11
D013315	Stress, Psychological NIH	0.09
D000067073	Psychological Trauma NIH	0.09
D001523	Mental Disorders NIH	0.06
D000066553	Problem Behavior NIH	0.06
D019052	Depression, Postpartum NIH	0.06
D016638	Critical Illness NIH	0.02
D018352	Coronavirus Infections NIH	0.01
D045169	Severe Acute Respiratory Syndrome NIH	0.01

Correlated HPO Terms (5)

---

	Name (Synonyms)	Correlation
HP:0000756	Agoraphobia HPO	0.22
HP:0000716	Depressivity HPO	0.21
HP:0002300	Mutism HPO	0.15
HP:0000722	Obsessive-compulsive behavior HPO	0.09
HP:0000708	Behavioral abnormality HPO	0.06

Primary Outcomes

Description: Pre- to post-CBT changes in functional, connectivity and structural MRI measures of brain networks relevant for anxiety. Brain regions include the amygdala, anterior insula, dorsal anterior cingulate cortex (dACC) and ventrolateral prefrontal cortex (vlPFC). Functional activation and connectivity of these brain regions are assessed using simple computer tasks performed during MRI scanning. Tasks engage threat reactivity, self-regulatory control and the interaction of these processes. Structural connections between regions will be measured using a MRI technique that measures water diffusion in the brain.

Measure: Brain function/structure as assessed by Magnetic Resonance Imaging scans

Time: Baseline and 12-weeks

---

Secondary Outcomes

Description: The Pediatric Anxiety Rating Scale (PARS) is a clinician-administered assessment to rate the severity of anxiety symptoms associated with common DSM-V anxiety disorders (social phobia, separation anxiety disorder, and generalized anxiety disorder) in children. The investigators are looking for decreases in anxiety severity ratings from pre- to post-treatment.

Measure: Pediatric Anxiety Rating Scale

Time: weeks 0, 3, 6, 9, 12

---

Primary Outcomes

Description: Error-related negativity (ERN) is assessed through the "Zoo task", a "Go/No-Go" paradigm assessing effortful control. Children view a series of animals on a computer screen and are asked to press a button when a new animal appears (Go trials), unless the animal is an orangutan (i.e., inhibit button response, No-Go trials). The task includes 8 blocks, each containing 30 unique animals (Go trials) and 10 orangutans (No-Go trials) in random order. Event related potentials (ERP; direct responses to stimuli measured using electroencephalography) will be examined from fronto-central recording sites time-locked to error and correct response. Differentiation between these trial types is the primary ERN measure, but ERN in error trials will also be considered, as well as ERPs in correct trials. The number of No-Go errors and response times (RTs) to Go trials will also be considered in analyses, as performance can affect ERN amplitude.

Measure: Change from Baseline Error Related Negativity (ERN) at Post-Intervention

Time: approximately 10 weeks

---

Description: Preschool participants watch age appropriate film clips (four fearful, four neutral, and four happy clips). White noise bursts are presented at varying time points to elicit the startle eyeblink response (FPS), recorded from two electrodes under the left eye.

Measure: Change from Baseline Fear Potentiated Startle (FPS) at Post-Intervention

Time: approximately 10 weeks

---

Secondary Outcomes

Description: Assessed using the Spence Anxiety Scale for Preschoolers (Spence, Rapee, McDonald, & Ingram, 2001). This 34-item parent-report scale provides an overall measure of child anxiety.

Measure: Change in Anxiety Symptoms

Time: approximately 10 weeks

---

Primary Outcomes

Description: The CY-BOCS is a measure of obsessive compulsive symptoms and severity. The Obsession Rating Scale measures 5 domains of obsessional severity on a scale from 0 (no impairment) to 4 (extreme impairment.) The Compulsion Rating Scale measures 5 domains of compulsion severity on a scale from 0 (no impairment) to 5 (extreme impairment.) The total range of OCD severity is reported on a scale from 0-40, with a higher score indicating greater severity.

Measure: Children's Yale-Brown Obsessive-Compulsive Scale

Time: In-treatment and follow-up (6-12 months)

---

Description: The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.

Measure: Pediatric Anxiety Rating Scale

Time: In-treatment and follow-up (6-12 months)

---

Secondary Outcomes

Description: The CSQ-8 measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.

Measure: Client Satisfaction Questionnaire-8

Time: In-treatment and follow-up (6-12 months)

---

Description: The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.

Measure: Clinical Global Impression Scales

Time: In-treatment and follow-up (6-12 months)

---

Description: The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.

Measure: Child Sheehan Disability Scale

Time: In-treatment and follow-up (6-12 months)

---

Description: The measure tracks both the quality and quantity of homework completed between treatment sessions. This form has been used previously by our research group in large-scale treatment trials, and has been helpful in determining barriers to homework completion.

Measure: Homework Compliance Form

Time: Up to 6 months

---

Description: The Exposure Guide is a exposure therapy fidelity/quality tool completed by study therapists. This tool collects information regarding the use of specific therapeutic tools during exposures.

Measure: Exposure Guide

Time: Up to 6 months

---

Description: The TASCP is a 12-item measure of therapeutic alliance between a caregiver and his/her child's therapist. This measure assesses the bond and collaboration between caregiver and therapist. Each item is rated using a scale from 0: "not true" to 4: "very much true."

Measure: Therapeutic Alliance Scales for Caregivers and Parents (TASCP)

Time: Up to 6 months

---

Description: 75 The TASC-r is a 12-item measure of therapeutic alliance between a child and his/her therapist. This measure assesses the degree of affective bond between child and therapist, as well as amount of therapeutic task collaboration. Each item is rated using a scale from 0: "not true" to 4: "very much true."

Measure: Therapeutic Alliance Scales for Children-Revised (TASC-r)

Time: Up to 6 months

---

Description: The PQ-LES-Q is a 13-item measure of child functioning in life that uses a 5-point ratings scale, with higher scores indicating better quality of life. This measure has both parent and child versions, assessing the same items from both child and parent perspectives. The measure assesses quality of the child's life in a variety of domains.

Measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)

Time: In-treatment and follow-up (6-12 months)

---

Description: The TPA is designed to independently solicit from youth and parent the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).

Measure: Top Problems Assessment (TPA)

Time: In-treatment and follow-up (6-12 months)

---

Description: The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.

Measure: Caregiver Strain Questionnaire (CSQ)

Time: In-treatment and follow-up (6-12 months)

---

Description: The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.

Measure: Barriers to Treatment Questionnaire - Parent Version (BTQ-P)

Time: In-treatment and follow-up (6-12 months)

---

Description: The PAS-PR is a 5-item questionnaire assessing the frequency and interference associated with accommodating the child's anxiety. Each item is followed by a series of common examples to illustrate the principle of accommodation for parents. Responses for frequency include 0 (never), 1 (rarely), 2 (occasionally), 3 (often), and 4 (always). Response options for interference due to accommodation include 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (extreme).

Measure: Pediatric Accommodation Scale-Parent Report (PAS-PR)

Time: In-treatment and follow-up (6-12 months)

---

Description: We will record reactions from caregivers and child to treatment assignment using this clinician-rated measure. It includes capturing both verbatim responses from caregivers and child, as well as asking for interviewer impressions reactions from caregivers and child to treatment group assignment following randomization. The clinician also records the likelihood that the family will remain in the study and adhere to study protocols.

Measure: Randomization Debrief

Time: Administered at baseline

---

Description: This measure is a 3-item self-report questionnaire that captures parental beliefs about the efficacy about each treatment condition (office-based or home/community-based) using a scale from 1:"I expect my child will be very much improved," to 7: "I expect my child will be very much worse." The parent is also asked to select which treatment option would be best for their family. There is also a patient version of this measure used to capture patient beliefs about the efficacy about each treatment condition (office-based or home/community-based) using the same scale. The patient is asked to select which treatment option they believe would be best for them and their family. The patient version of this measure will be completed by youth 12+.

Measure: Treatment Expectancy

Time: Administered at baseline

---

Description: The SRS-2 is a 65-item self-report measure administered to caregivers or teachers to assess their perception of the presence of a child's social impairment. This measure is used to evaluate children aged 4-18 years old. Items are rated on a scale from 1 ("not true") to 4 ("almost always true").

Measure: The Social Responsiveness Scale, Second Edition (SRS-2)

Time: Administered at baseline and at discharge (up to 6-months)

---

Description: The ARI-P is a 7-item parent report questionnaire assessing child's irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

Measure: Affective Reactivity Index - Parent Version (ARI-P)

Time: In-treatment and follow-up (6-12 months)

---

Description: The ARI-S is a 7-item self-report report questionnaire assessing irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

Measure: Affective Reactivity Index - Self Report (ARI-S)

Time: In-treatment and follow-up (6-12 months)

---

Description: The Distress Intolerance Index is a 10-item self-report report questionnaire assessing the inability to tolerate negative somatic and emotional states. Items are rated on a 5-point scale from "very little" (0) to "very much".

Measure: Distress Intolerance Index

Time: In-treatment and follow-up (6-12 months)

---

Description: The PAS is a 12-item questionnaire assessing the frequency of and beliefs about parental accommodation. The frequency of parental accommodation is measured on a scale from "Never/Almost Never" (0), to "Always/Almost Always" (3). The beliefs about parental accommodation are measured on a scale from "Strongly Disagree" (0), to "Strongly Agree" (3).

Measure: Parent Accommodation Scale (PAS)

Time: In-treatment and follow-up (6-12 months)

---

Description: The feedback form is a 3-item self-report questionnaire that asks caregivers or child which treatment group their family was in and for open-ended feedback about their experience in the study (i.e. what did they really like, what would they change, general suggestions/ comments). All responses on this survey are received anonymously. Caregivers and children complete separate feedback forms. Children 8+ will complete the child version of this measure.

Measure: Feedback Forms - Caregiver and Child Versions

Time: Administered only at discharge, up to 6-months into study

---

Description: This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.

Measure: End of Treatment Form

Time: Administered only at discharge, up to 6-months into study

---

Description: This 7-item measure asks for participants' caregivers to discuss to whom they would like the findings of the study to be disseminated (i.e., local policy makers, educators, etc.). Additionally, it asks for information on how they would like findings to be shared (i.e., via social media, presentations, etc.) as well as caregivers to share highlights of their experience in the study.

Measure: Sharing Study Findings

Time: Administered only at discharge, up to 6-months into study

---

Description: We will record the rate of session reschedules, cancellations and no-shows, along with the overall number of sessions attended. We will also document the reason why a scheduled appointment does not occur using the Treatment Cancellation Form.

Measure: Treatment Attendance

Time: Up to 6 months

---

Description: This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.

Measure: Reasons for Treatment Discontinuation form

Time: Administered only at discharge, up to 6-months into study

---

Primary Outcomes

Description: Pre- to post-CBT changes in brain activation and function connectivity in the task-control network including fronto-parietal and cingulo-opercular regions mediating cognitive control. Functional activation and connectivity of these brain regions are assessed using a conflict interference computer task performed during MRI scanning.

Measure: Change in Brain activation and connectivity in the task-control network (TCN)

Time: Baseline, 12 weeks (after therapy)

---

Secondary Outcomes

Description: This is a 50 question interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The total scores on this scale range from 0 to 30, with scores above 13 indicating clinically meaningful anxiety.

Measure: Change in Pediatric Anxiety Rating Score (PARS)

Time: Baseline, 12 weeks (after therapy)

---

Description: Pre- to post-CBT changes in the behavioral performance in a conflict interference task, as well as, composite score from tasks included in the NIH toolbox

Measure: Change in behavioral performance on the conflict interference task and tasks testing cognitive control capacity included in the NIH Toolbox.

Time: Baseline, 12 weeks (after therapy)

---

Primary Outcomes

Description: Change in anxiety will be measured by the Spence Children's Anxiety Scale (SCAS) designed by Spence (1998). The SCAS (45-item) is self-report scale with a 4-point Likert type, consisting of 44 items and one open-ended question. Overall assessment is done by total score.

Measure: Change in anxiety

Time: Baseline & at 2 weeks

---

Secondary Outcomes

Description: Syndromes of digital eye strain will be measured with the Computer Vision Syndrome Questionnaire (CVS‐Q) designed by Seguí et al (2015). The self-reported CVS-Q questionnaire (16-item) evaluates the frequency (never, occasionally or often/always) and the intensity (moderate or intense) of 16 symptoms: burning, itching, feeling of a foreign body, tearing, excessive blinking, eye redness, eye pain, heavy eyelids, dryness, blurred vision, double vision, difficulty focusing for near vision, increased sensitivity to light, colored halos around objects, feeling that sight is worsening, and headache. Overall assessment is done by total score.

Measure: Change in syndromes of digital eye strain

Time: Baseline & at 2 weeks

---

Description: The PROMIS pediatric sleep disturbance questionnaire (4-item), designed by Forrest et al (2018), assesses self-reported experiences of sleep disturbance over the past 7 days. Raw score will be converted to T-Score.

Measure: Change in sleeping quality

Time: Baseline & at 2 weeks

---

Description: Participants will be asked to indicate the average time in hours per day spent on each the following activities: reading, writing, computer/PAD use, smart phone, watching TV, and playing video games.

Measure: Changes in time (hour) spent on different near work activities

Time: Baseline & at 2 weeks

---

Primary Outcomes

Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.

Measure: Characteristics of COVID-19-related anxiety

Time: 1 day

---

Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.

Measure: COVID-19-related anxiety symptoms

Time: 1 day

---

Secondary Outcomes

Description: Self-efficacy and coping with the COVID-19 pandemic are measured with 13 self created items. Values ranging from 1 to 6; higher scores indicate a better outcome (except inverted items).

Measure: Self-efficacy and coping with COVID-19

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Description: Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.

Measure: Consequences of COVID-19 in the last three weeks.

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Description: General illness attitudes are measured with 3 subscales (Worry about illness; Thanatophobia; Bodily preoccupations) of the German version of the Illness Attitude Scales (IAS) by Hiller & Rief (2004). 9 Items; values ranging from 1 to 5, higher scores indicate a worse outcome.

Measure: General Illness Attitude

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Description: Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.

Measure: Media reporting

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Description: To screen for general anxiety and depressive symptoms the German version of the Patient Health Questionnaire-4 (PHQ-4) by Löwe (2015) is used. 4 items; values ranging from 0 to 3, higher scores indicate a worse outcome.

Measure: Ultra-brief screening scale for anxiety and depression

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.

Measure: Change in characteristics of COVID-19-related anxiety

Time: Ebaseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.

Measure: Change in COVID-19-related anxiety symptoms

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

---

Primary Outcomes

Description: Thoughts and feelings about mental health impact of COVID-19

Measure: NIMH COVID Study survey - adult responses

Time: Biweekly online responses

---

Secondary Outcomes

Description: Ratings on measures of mental health symptoms and distress

Measure: DSM XC and KS survey

Time: Biweekly online self report

---

Primary Outcomes

Measure: Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).

Time: Week 0

---

Measure: Depression at baseline measured by the 7-item depression subscale of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21—Depression); in terms of proportions (0-4 vs ≥ 5).

Time: Week 0

---

Measure: Anxiety at baseline measured by the 7-item anxiety subscale of the DASS-21 (DASS-21—Anxiety); in terms of proportions (0-3 vs ≥ 4).

Time: Week 0

---

Measure: Stress at baseline measured by the 7-item stress subscale of the DASS-21 (DASS-21—Stress); in terms of proportions (0-7 vs ≥ 8).

Time: Week 0

---

Secondary Outcomes

Measure: Distress measured at baseline by the CPDI; in terms of continuous values.

Time: Week 0

---

Measure: Depression at baseline measured by the DASS-21—Depression; in terms of continuous values.

Time: Week 0

---

Measure: Anxiety at baseline measured by the DASS-21—Anxiety; in terms of continuous values.

Time: Week 0

---

Measure: Stress at baseline measured by the DASS-21—Stress; in terms of continuous values.

Time: Week 0

---

Measure: Domain-specific quality of life at baseline measured by the 7-item physical health domain of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire (WHOQOL-BREF—Physical health); in terms of continuous values.

Time: Week 0

---

Measure: Domain-specific quality of life at baseline measured by the 6-item psychological health domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF—Psychological health); in terms of continuous values.

Time: Week 0

---

Measure: Domain-specific quality of life at baseline measured by the 3-item social relationships domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF—Social relationships); in terms of continuous values.

Time: Week 0

---

Measure: Domain-specific quality of life at baseline measured by the 8-item environment domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF—Environment); in terms of continuous values.

Time: Week 0

---

Measure: Overall perception of quality of life and overall perception of health at baseline measured by the two items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire—in terms of continuous values.

Time: Week 0

---

Measure: Change from baseline in distress measured by CDPI; in terms of continuous values.

Time: 24 weeks

---

Measure: Change from baseline in depression measured by the DASS-21—Depression; in terms of continuous values.

Time: 24 weeks

---

Measure: Change from baseline in anxiety measured by the DASS-21—Anxiety; in terms of continues values.

Time: 24 weeks

---

Measure: Change from baseline in stress measured by the DASS-21—Stress; in terms of continuous values.

Time: 24 weeks

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Measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF—Physical health; in terms of continuous values.

Time: 24 weeks

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Measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF—Psychological health; in terms of continuous values.

Time: 24 weeks

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Measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF—Social relationship; in terms of continuous values.

Time: 24 weeks

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Measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF—Environment; in terms of continuous values.

Time: 24 weeks

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Measure: Change from baseline in overall perception of quality of life and overall perception of health measured by the 2 items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire; in terms of continuous values.

Time: 24 weeks

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Measure: The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics

Time: Week 0-6-12-24

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Primary Outcomes

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 1 month

Time: 1 month post discharge

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Secondary Outcomes

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 3 months

Time: 3 months post discharge

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Description: Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

Measure: Depression 3 months

Time: 3 months post discharge

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Description: PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

Measure: Post Traumatic Stress Disorder (PTSD) symptoms 3 months

Time: 3 months post discharge

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Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 12 months

Time: 12 months post discharge

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Description: PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

Measure: Post Traumatic Stress Disorder (PTSD) symptoms 12 months

Time: 12 months post discharge

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Description: Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

Measure: Depression 12 months

Time: 12 months post discharge

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Primary Outcomes

Description: The Mediterranean Diet Score (MedDiet Score) will be calculated and correlated to the Anxiety Score (GAD-7)

Measure: The association between Mediterranean Diet Score and Anxiety Score

Time: through study completion, average six months

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Description: Mediterranean Diet Score (MedDiet) will be calculated

Measure: The degree to which current dietary intake is consisten with the Mediterranean Diet

Time: through study completion, average six months

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Secondary Outcomes

Description: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety (GAD-7)

Measure: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety

Time: through study completion, average six months

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Primary Outcomes

Description: The COVID-19 anxiety inventory is a self-report questionnaire screening for concerns and fears regarding COVID-19 contagion. The Inventory consists of 6 items. Scores can range from 6 to 30, with higher scores denoting higher symptom severity.

Measure: Change from baseline of the total score of a novel COVID-19 anxiety inventory

Time: up to 2 days pre-treatment and 1-2 days post-treatment

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Secondary Outcomes

Description: The Health Anxiety Inventory (HAI) is a validated self-report measure assessing health anxiety. Total score can range from 0 to 42, with higher scores denoting higher symptom severity

Measure: Change from baseline of the total score of the Health Anxiety Inventory

Time: up to 2 days pre-treatment and 1-2 days post-treatment

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Description: The State Anxiety Inventory is a validated self-report measure for state anxiety. Total score can range from 20 to 80, with higher scores denoting higher levels of state anxiety.

Measure: Change from baseline of the total score of the State Anxiety Inventory

Time: up to 2 days pre-treatment and 1-2 days post-treatment

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Description: The PHQ-9 is a 9-item self-report scale for depression symptoms. Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.

Measure: Change from Baseline of the total score of the PHQ-9

Time: up to 2 days pre-treatment and 1-2 days post-treatment

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Description: The GAD-7 is a 7-item self-report scale for generalized anxiety symptoms. Scores can range from 0 to 21, with higher scores reflecting more symptoms of generalized anxiety.

Measure: Change from Baseline of the total score of the GAD-7

Time: up to 2 days pre-treatment and 1-2 days post-treatment

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Primary Outcomes

Description: Assessed by survey questions (in part adapted from GAD7)

Measure: Anxiety

Time: Immediate post-intervention (compare with pre-intervention data)

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Description: Assessed by survey questions (in part adapted from WHO-5)

Measure: Well-being

Time: Immediate post-intervention (compare with pre-intervention data)

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Secondary Outcomes

Description: Assessed by survey questions

Measure: Future outlook & hopefulness

Time: Immediate post-intervention (compare with pre-intervention data)

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Description: Assessed by survey questions

Measure: Sleep habits

Time: Immediate post-intervention (compare with pre-intervention data)

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Description: Assessed by survey questions (frequency of consuming whole foods and prepared meals)

Measure: Nutrition habits

Time: Immediate post-intervention (compare with pre-intervention data)

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Description: Assessed by survey questions (anticipated and actual continued usage of app)

Measure: Meditation app continued usage

Time: Immediate post-intervention (compare with pre-intervention data)

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Description: Assessed by survey questions (in part adapted from GAD7)

Measure: Anxiety

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

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Description: Assessed by survey questions (in part adapted from WHO-5)

Measure: Well-being

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

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Description: Assessed by survey questions

Measure: Future outlook & hopefulness

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

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Description: Assessed by survey questions

Measure: Sleep habits

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

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Description: Assessed by survey questions (frequency of consuming whole foods and prepared meals)

Measure: Nutrition habits

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

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Description: Assessed by survey questions (anticipated and actual continued usage of app)

Measure: Meditation app continued usage

Time: 2 months post-intervention (compare with immediate post-intervention data)

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Primary Outcomes

Description: Three items from the Danish Parental Stress Scale (PSS) was selected, which intends to be a short measure of perceived stress resulting from being a parent (Pontoppidan et al., 2018). The scale consists of nine items measuring parental stress where each is measured on a five-point Likert scale (1-5), with the scores ranging from 3 to 15. Higher scores indicate higher parental stress. The following three were chosen in this large-scale investigation: 1) I feel overwhelmed by the responsibility of being a parent. 2) The major source of stress in my life is my child(ren), and 3) It is difficult to balance different responsibilities because of my child(ren) (Pontoppidan et al., 2018).

Measure: Measure of parental stress

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

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Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

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Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, and scores that are above the cutoff of 10 are considered to be in the clinical range (Spitzer et al., 2006). Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

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Primary Outcomes

Description: To examine patterns of neural circuits connectivity as potential predictors of rating scores of affective, cognitive and behavioral (including task performance) responses to COVID-19 among healthy and clinically anxious participants who already participants in SNFA resting-state connectivity studies.

Measure: Patterns of neural connectivity as predictors

Time: Baseline and 8 months later

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Primary Outcomes

Description: Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points

Measure: Anxiety

Time: 4 months

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Description: Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points

Measure: Depression

Time: 4 months

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Primary Outcomes

Description: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.

Measure: Evaluation of depression and anxiety score changes of covid-19 positive pregnants

Time: 4 months

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Primary Outcomes

Description: Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)

Measure: GAD-7

Time: Up to 32 weeks

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Description: Health Anxiety 8-item scale (range 0-32, higher is worse)

Measure: Whiteley 8

Time: Up to 32 weeks

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Secondary Outcomes

Description: Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)

Measure: PHQ-8

Time: Up to 32 weeks

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Description: Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)

Measure: SS-8

Time: Up to 32 weeks

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Description: An 8-item self-report measure of cognitive function (range 8-40, higher is worse)

Measure: Applied Cognition 1.0

Time: Up to 32 weeks

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Description: A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)

Measure: PROMIS-4 Sleep Disturbance

Time: Up to 32 weeks

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Description: Emotional Regulation Questionnaire - a 10-item measure of emotional regulation; the reappraisal subscale has a range: of 6-42, higher score is considered positive; while the suppression subscale has a range of 4-28, higher score considered negative. ..

Measure: ERQ

Time: Up to 32 weeks

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Description: A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher represents higher perception of stress)

Measure: Perceived Stress Scale

Time: Up to 32 weeks

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Description: A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)

Measure: Brief Hypervigilance Scale

Time: Up to 32 weeks

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Primary Outcomes

Description: During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.

Measure: Mothers' anxiety rate

Time: 30 days

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Primary Outcomes

Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Measure: Depression, anxiety and stress

Time: 2 weeks

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Secondary Outcomes

Description: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.

Measure: Post-traumatic stress syndrome

Time: 2 weeks

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Description: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

Measure: Insomnia

Time: 2 weeks

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Description: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Measure: Self Efficacy

Time: 2 weeks

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Primary Outcomes

Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome

Measure: Change in professional quality of life

Time: Before peer support program, through study completion (an average of 7 months)

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Secondary Outcomes

Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)

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Primary Outcomes

Description: The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Measure: Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)

Time: 10 minutes

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Description: The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

Measure: Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit

Time: 10 minutes

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Description: The occurrence of reduced access to medical and psychological help by means of an adjusted survey.

Measure: Reduced access to medical and psychological help

Time: 10 minutes

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Primary Outcomes

Description: Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).

Measure: Participation Barriers

Time: The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).

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Description: Number of participants that were eligible for the study.

Measure: Number of Eligible Participants

Time: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.

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Description: Number of participants that were approached for the study.

Measure: Number of Participants Approached

Time: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.

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Description: Number of participants consented for the study.

Measure: Number of Participants Consented

Time: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.

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Description: Rates of refusal for participation in the study.

Measure: Rates of Refusal

Time: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

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Description: Reasons for refusal for participation in the study.

Measure: Reasons for Refusal

Time: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

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Description: The average number of sessions completed in total will be captured to evaluate intervention adherence.

Measure: Number of Sessions Completed in Total

Time: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.

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Description: The adherence index (calculated using the formula: sessions completed/total sessions scheduled [sum of sessions attended, rescheduled, no-showed and cancelled]) will be used to evaluate intervention adherence.

Measure: Adherence Index

Time: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.

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Description: The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.

Measure: Amount of time (in weeks) to complete the intervention

Time: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.

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Description: The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Intervention Acceptability

Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

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Description: The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Participant Satisfaction

Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

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Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after First Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).

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Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Sixth Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).

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Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Final Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

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Secondary Outcomes

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic at Baseline

Time: CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).

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Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic after Final Intervention Session

Time: CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).

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Description: To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.

Measure: Efficacy of Virtual-Care CBT Intervention

Time: The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).

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Description: In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.

Measure: Clinician Virtual Care Experience

Time: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.

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Primary Outcomes

Description: This scale will explore the effort and confidence of the participants. The minimum score for each facet is 10, and the maximum score is 70.

Measure: Academic Self-Concept Scale Score

Time: up to 3 months

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Description: This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27.

Measure: PHQ-9 Score

Time: up to 3 months

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Description: This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21.

Measure: GAD-7 Score

Time: up to 3 months

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Description: Students' preference of classroom or online classes.

Measure: Preference of teaching method

Time: up to 3 months

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Description: Students' perception of changes in their academic performance: got better, worse, or stayed the same.

Measure: Self perceived academic performance

Time: up to 3 months

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Description: Students' perception of changes in their grades: got better, worse, or stayed the same.

Measure: Academic grades changes

Time: up to 3 months

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Primary Outcomes

Description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).

Measure: Objective Cognition - Computerized Cognitive Tasks

Time: Up to 10 weeks

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Description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).

Measure: Objective Cognition - Computerized Cognitive Tasks

Time: Up to 10 weeks

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Description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).

Measure: Objective Cognition - Computerized Cognitive Tasks

Time: Up to 10 weeks

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Description: A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.

Measure: Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire

Time: Up to 10 weeks

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Description: 5- item questionnaire that assess anxiety related to the Coronavirus.

Measure: Coronavirus Anxiety Scale

Time: Up to 10 weeks

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Description: Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.

Measure: Anxiety - State-Trait Anxiety Inventory

Time: Up to 10 weeks

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Secondary Outcomes

Description: During the intervention phase the cognitive training group will play games and will need to log the days and duration played.

Measure: Game-related experience- Sessions and duration played

Time: Up to 10 weeks

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Description: 19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.

Measure: Circadian Rhythm- Morningness-Eveningness Questionnaire

Time: Up to 10 weeks

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Description: Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a likert scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.

Measure: Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale

Time: Up to 10 weeks

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Description: Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.

Measure: Subjective Arousal- Pre-sleep Arousal Scale

Time: Up to 10 weeks

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Description: Arousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.

Measure: Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale

Time: Up to 10 weeks

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Description: Questionnaire assessing the experience of the game.

Measure: Game Engagement Questionnaire

Time: Up to 10 weeks

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Description: 21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.

Measure: Mood-Depression-Beck Depression Inventory-II

Time: Up to 10 weeks

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Description: 10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.

Measure: Alcohol Use - Alcohol Use Disorder Test

Time: Baseline

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Description: 7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.

Measure: Physical Activity - International Physical Activity Questionnaire

Time: Up to 10 weeks

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Description: 10 question assessment measuring personality.

Measure: Personality - Big Five Inventory

Time: Baseline

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Description: 20- item questionnaire assessing the effects of news and social media on perception of COVID-19.

Measure: COVID-19 related media exposure and risk questions

Time: Up to 10 weeks

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Description: 16- item questionnaire about the use of the intervention.

Measure: Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire

Time: Up to 10 weeks

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Description: This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.

Measure: Computer Proficiency- Computer Proficiency Questionnaire

Time: Baseline

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Description: Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.

Measure: Subjective Behavioral Sleep- Insomnia Severity Index

Time: Up to 10 weeks

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Description: 21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.

Measure: Beck Depression Inventory-2nd Edition

Time: Up to 10 weeks

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Description: Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

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Description: Online diaries completed each morning (~5 mins); diaries measure sleep onset latency

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

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Description: Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

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Description: Online diaries completed each morning (~5 mins); diaries measure total sleep time

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

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Description: Online diaries completed each morning (~5 mins); diaries measure sleep quality

Measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

Time: Up to 10 weeks

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Primary Outcomes

Description: 6 items - age, sex, city of residence, marital status, level of education, employment status

Measure: sociodemopraphic factors

Time: 5 months

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Description: Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress

Measure: perceived stress

Time: 5 months

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Description: The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety

Measure: level of anxiety

Time: 5 months

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Description: EQ5D-VAS, 1 item to examine health status

Measure: self-reported health state

Time: 5 months

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Description: Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.

Measure: number of complaints

Time: 5 months

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Description: Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations

Measure: strategies in coping with stressful situations

Time: 5 months

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Description: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic).

Measure: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic

Time: 5 months

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Description: The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression

Measure: level of depression

Time: 5 months

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Primary Outcomes

Description: • The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.

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Description: • The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.

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Primary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.

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Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.

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Primary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: The Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.

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Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.

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Primary Outcomes

Description: Self-reported symptoms with the Depression, Anxiety and Stress Scale (DASS-21), which have 21 items, each scoring between 0 and 3, the minimum score is 0 and the maximum score of 63. The cut-off score for the depression subscale is 6, Anxiety is 5, Stress is 6.

Measure: Depression, Anxiety and Stress Scale (DASS-21)

Time: Up to 4 weeks

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Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment. This scale has 6 items and each item has to be answered Yes or No. The total score is 6. A score of 0 is no ideation is present.

Measure: Columbia-Suicide Severity Rating Scale (C-SSRS)

Time: Up to 4 weeks

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Description: Self-report of harmful alcohol drinking. 4 items. CAGE stands for: C: Have you felt the need to Cut down drinking? A: Have you ever felt Annoyed by criticism of drinking? G: Have you had Guilty feelings about drinking? E: Do you ever take a morning Eye opener (a drink first thing in the morning to steady your nerves or get rid of a hangover)? The range score goes from 0 to 4. The point cut off is >= 2.

Measure: CAGE

Time: Up to 4 weeks

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Description: Adaptation of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) interview model, including prescription and nonprescription drugs and vaping. It has 8 items exploring the frequency of substance use in the last 3 months (daily, weekly, yearly) and the problems associated with the use. It explores the use of 10 kinds of drugs.

Measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Time: Up to 4 weeks

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Secondary Outcomes

Description: Ad hoc self-report survey: Current age University enrollment year Current years of study Sex Gender Civil status Parenting and number of child(s) Nationality Etnicity Ocupational situation: only study, part-time worker, fulltime worker and study Carrer Maximum parents studies degree: analphabet, school, undergraduate, postgraduate; complete or incomplete studies. Payment of studies: credit, schollarship, self-pay Travel time from home to campus: minutes, hours.

Measure: Sociodemographic characteristics

Time: Up to 4 weeks

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Description: Self-perception on a subjective analogous scale of physical health

Measure: General Health perception

Time: Up to 4 weeks

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Description: Self-perception on a subjective analogous scale of mental health

Measure: General Menta Health perception

Time: Up to 4 weeks

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Description: Ad hoc self-report survey of any previous chronic physical disease

Measure: History of chronic diseases

Time: Up to 4 weeks

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Description: Ad hoc self-report survey of minutes of physical activity during the past week

Measure: Physical activity

Time: Up to 4 weeks

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Description: Ad hoc self-report survey of time spent with friends or social gatherings

Measure: Social activities

Time: Up to 4 weeks

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Description: Family functionality APGAR score: a 5-item measure of perceived family support in the domains of adaptation, partnership, growth, affection, and resolve. E.g. "I find that my family accepts my wishes to take on new activities or make changes in my lifestyle". Scores range from 0 to 10, being 10 a total satisfaction with family functionality.

Measure: Family functionality (APGAR)

Time: Up to 4 weeks

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Description: Ad hoc self-report questionnaire of personal and family mental health history: Previous diagnosis of depression, bipolar disorder, panic attacks, anxiety disorders, eating disorders, ADHD. Current psychotherapy of psychiatric medication Family history of psychiatric disorders

Measure: History of personal and family mental health problems

Time: Up to 4 weeks

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Description: Self-report of insomnia perception. it has 7 items, and responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores ranges from 0 to 28. A clinical Insomnia threshold score of 15.

Measure: Insomnia Severity Index (ISI)

Time: Up to 4 weeks

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Description: Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.

Measure: University violence and bullying

Time: Up to 4 weeks

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Description: Ad hoc self-report survey of sexual health, including sexual orientation, the current status of an emotional relationship, number of sex partners in the last year, history of Sexually Transmitted Disease (STD).

Measure: Sexuality and sexual health

Time: Up to 4 weeks

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Description: Sense of Social and Academic Fit (SSAF) is a self-report questionnaire of 17 items, with responses on a Likert format from 1-7. It measures academic and social sense of belonging. The score is produced as the average of the scores reported in each item. The minimum score is 1 and the maximum score is 17. A higher score means higher sense of belonging.

Measure: Sense of Social and Academic Fit (SSAF)

Time: Up to 4 weeks

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Description: Ad-hoc self-report survey of current perception and possible diagnosis of COVID-19: Fear or preoccupation about getting COVID-19 Sense of severity if diagnosed with COVID-19 Fear or preoccupation about a family member or friend to get COVID-19 Current diagnosis of COVID-19 A family member diagnosed with COVID19 Sense of compliance with social isolation and quarantine Persons living with (family, friends, alone) Frequency of: going out of home, gather with others, virtual socialization, keeping a routine, exercise realized, recreative activities, meditation or prayer, seek information about the situation of COVID19 Frequency of the following symptoms: nervousness, hopelessness, depression, amount of effort required to realize activities, self-value, anhedonia.

Measure: COVID-19 questions

Time: Up to 4 weeks

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Primary Outcomes

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Day 12

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Secondary Outcomes

Description: The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.

Measure: Depression as measured by the patient health questionnaire 9 (PHQ-9)

Time: 12 days and week 8

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Description: The Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.

Measure: Trauma as measured by Trauma screening questionnaire (TSQ)

Time: 8 weeks

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Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Week 8

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Other Outcomes

Description: Risk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.

Measure: Risk associated with distress

Time: Baseline analysis

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Description: Framework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.

Measure: Qualitative analysis

Time: Baseline

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Primary Outcomes

Description: Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.

Measure: Liebowitz Social Anxiety Scale (LSAS)

Time: 12 weeks

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Description: Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.

Measure: Satisfaction with Therapy and Therapists Scale (STTS)

Time: 12 weeks

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Description: Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.

Measure: UCLA Loneliness Scale version 3

Time: 12 weeks

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Secondary Outcomes

Description: Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.

Measure: Liebowitz Social Anxiety Scale (LSAS)

Time: 24 weeks

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Description: Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.

Measure: UCLA Loneliness Scale version 3

Time: 24 weeks

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Primary Outcomes

Description: Changes in the level of physical activity (questionnaire from RICCI-GAGNON)

Measure: Physical activity measure

Time: 1 day

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Secondary Outcomes

Description: To evaluate the f the level of anxiety and depression by questionnaire HAD

Measure: Depression

Time: 1 day

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Description: To evaluate the level of slepp activity by questionnaire LEEDS

Measure: Sleep quality

Time: 1 day

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Description: To evaluate the food activity by questionnaire LEEDS

Measure: food activity

Time: 1 day

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Description: To evaluate of the activity level of chronic pathology (monitoring criteria in accordance with good clinical practice) in patients with chronic pathology by questionnaire

Measure: activity level of chronic pathology

Time: 1 day

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Primary Outcomes

Description: Total number of participants

Measure: Number of participants enrolled over 3 months

Time: 3 months

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Description: Count of participants enrolled each week

Measure: Number of participants enrolled per week over 3 months

Time: 3 months

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Description: Proportion of participants who enroll out of the total who access the consent form

Measure: Proportion of participants who enroll in the study over 3 months

Time: 3 months

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Description: Proportion of participants that reach the final page of the study out of the total who provided informed consent

Measure: Proportion of participants who complete the study over 3 months

Time: 3 months

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Description: Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire

Measure: Proportion of missing data over 3 months

Time: 3 months

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Description: Proportion of participants who self-report watching the video in its entirety and for whom time stamps show that the time elapsed on the page where the video is embedded is greater than or equal to 80% of the length of the video

Measure: Proportion of participants who complete the 45-minute video over 3 months

Time: 3 months

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Secondary Outcomes

Description: The State Trait Anxiety Inventory (STAI) - Y6 is a 6-item, validated self-report questionnaire that assesses state anxiety when used with instructions that specify: "indicate how you feel right now, in this moment." Responses to each item are provided on a 4 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the mean of 6 items, multiplied by 20 to use the interpretation guide for the full STAI scale.

Measure: Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form

Time: immediately before/after

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Description: The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness. The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body. Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the sum of scores from each subscale. For this outcome, the State Mindfulness of Mind subscale will be used.

Measure: Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)

Time: immediately before/after

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Description: The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness. The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body. Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the sum of scores from each subscale. For this outcome, the State Mindfulness of Body subscale will be used.

Measure: Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)

Time: immediately before/after

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Primary Outcomes

Description: Sociodemographic information and training characteristics Participants asked to provide sociodemographic information. Also, the difference in training frequency, duration, and quality after COVID-19 pandemic measured via 22 self-created questions.

Measure: Sociodemographic information and training characteristics

Time: at inclusion

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Description: The Beck Anxiety Inventory (Beck et al., 1988) has been widely used to measure the severity of anxiety by self-report and showed to has internal consistency and high test-retest reliability. The Turkish version of the BAI proved to be a reliable and valid measure (Ulusoy et al., 1993). The participant rates how much each symptom has bothered him/her in the past week in the 21-item self-report questionnaire. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (4).

Measure: The Beck Anxiety Inventory (BAI)

Time: one week

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Description: The Visual Analogue Scale (0 not stressed at all - 10 maximum amount of stress) used to measure self-reported stress and anxiety in elite athletes before and during the COVID-19 pandemic. The VAS showed to be an efficient tool for assessing self-reported stress and anxiety.

Measure: The Visual Analogue Scale (VAS)

Time: at inclusion

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Description: The 14-item version of PSS scale asks patients how often they had experienced thoughts and feelings such as control irritations and stress during the previous one month, with responses ranging from 0 (never) to 4 (very often). The Turkish PSS proved to be a reliable and valid tool to measure perceived stress. The final score obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress.

Measure: Perceived Stress Scale (PSS)

Time: one month

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Description: The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985) is a 5-item measure designed to measure global cognitive judgments of one's life satisfaction. The answers ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score with higher scores indicating a greater degree of satisfaction with life.

Measure: Satisfaction with Life Scale

Time: at inclusion

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Description: The BRUMs scale is based on the Profile of Mood States. The Turkish version of the BRUMS scale studied on Turkish athletes, 24-item measures and six subscales in the original version decreased to 19 items and four subscales: anger, depression, vigor, fatigue. The results of the study proved to be valid and reliable (Cakiroglu et al., 2016). Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within the subscale are summed and a score range from 0 to 16.

Measure: Brunel mood scale (BRUMS)

Time: at inclusion

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Primary Outcomes

Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants

Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

Time: 12 months

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Secondary Outcomes

Description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms

Measure: Post-Traumatic stress disorder

Time: 6 months post-hospital discharge

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Description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression

Measure: Anxiety and depression

Time: 6 months

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Description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

Measure: Cognitive function

Time: 6 months post-hospital discharge

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Description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

Measure: Health Related Quality of Life

Time: 6 months post-hospital discharge

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Description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

Measure: Health and disability

Time: 6 months post-hospital discharge

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Description: Wrist worn physical activity monitoring

Measure: Physical activity

Time: 6 months post-hospital discharge

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Description: Patient generated subjective global assessment

Measure: Nutritional status

Time: 6 months post-hospital discharge

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Primary Outcomes

Description: By questionnaire

Measure: correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university

Time: 2 months

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Primary Outcomes

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) - Scale: 0-3 (0 = never, 3 = frequently)

Measure: Change in Stress

Time: Baseline, week 6, week 12

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Description: 14 Item Resilience Scale (RS-14) - Scale: 1-7 (1 = strongly disagree, 7 = strongly agree)

Measure: Change in Resilience

Time: Baseline, week 6, week 12

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Description: The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Scale: 1-5 (1 = very poor, 5 = very good)

Measure: Change in Quality of Life Assessment

Time: Baseline, week 6, week 12

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Description: Generalized Anxiety Disorder 7 (GAD-7) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

Measure: Change in Symptom Severity - 1

Time: Baseline, week 6, week 12

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Description: Montgomery-Asberg Depression Rating Scale (MADRS) - Scale: 0-6 (0 = not at all, 6 = frequent/very much)

Measure: Change in Symptom Severity - 2

Time: Baseline, week 6, week 12

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Description: Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

Measure: Change in Symptom Severity - 3

Time: Baseline, week 6, week 12

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Secondary Outcomes

Description: Healthcare providers who administered the e-psychotherapy for duration of project will be asked through focus groups questions surrounding the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to participant, and any perceived benefits/drawbacks to e-psychotherapy.

Measure: Qualitative Information: Healthcare Providers

Time: Week 12

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Description: In focus groups, participants will be asked questions regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) that could impact participant experience with e-psychotherapy. This will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.

Measure: Qualitative Information: Personal, social, and cultural factors

Time: Week 12

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Primary Outcomes

Description: anxiety increase in SARS-CoV-2 in humans.

Measure: Anxiety in SARS-CoV-2

Time: 4 weeks

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Description: The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.

Measure: Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale

Time: 4 weeks

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Primary Outcomes

Description: test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety

Measure: Results of the Generalized Anxiety Disorder (GAD-7)

Time: 5 Minutes

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Secondary Outcomes

Description: Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Mental Health questionnaire

Time: 5 minutes

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Description: assess depression during the pandemic Scored between 0-27: Cut offs: 0-4 = None 5-9 = Mild depression 10-14 = Moderate depression 15-19 = Moderately severe depression 20-27 = Severe depression

Measure: Results of the Patient Health Questionnaire (PHQ-9)

Time: 5 minutes

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Description: Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Post Traumatic Stress Disorder (PTSD-8)

Time: 5 minutes

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Description: Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)

Time: 5 minutes

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Primary Outcomes

Description: Changes in anxiety symptoms will be assessed through the STICSA to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.

Measure: State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)

Time: 8 weeks

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Secondary Outcomes

Description: Due to the level of ongoing uncertainty that exists surrounding COVID-19, changes in intolerance of uncertainty will be assessed by the 27-item IUS to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing intolerance of uncertainty. The IUS can be scored across two-factors, in addition to a total score. Factor 1 includes items assessing uncertainty as having negative behavioural and self-referent implications (e.g., uncertainty keeps me from living a full life) and Factor 2 assesses uncertainty as being unfair and spoiling things in life (e.g., I can't stand being taken by surprise). Items are rated on a 5-point Likert type scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).

Measure: Intolerance of Uncertainty Scale (IUS)

Time: 8 weeks

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Description: Changes in worry symptoms will be assessed by the PSWQ. The PSWQ is a 16-item self-administered tool designed to assess worry symptoms. Items are assessed on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me), with higher scores indicating increased worry.

Measure: Penn State Worry Questionnaire (PSWQ)

Time: 8 weeks

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Description: Changes in mood symptoms will be assessed through the EPDS. Items on the EPDS are rated from 0-3, with higher total scores indicating more depressive symptoms. Possible scores on the EPDS range from 0-30. A clinical cut-off of 13 is used to indicate probable depression.

Measure: Edinburgh Postnatal Depression Scale (EPDS)

Time: 8 weeks

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Description: Changes in worry and anxiety associated with COVID-19 will be examined using the CSS. The CSS is a 36-item self-report scale designed to measure worry and anxiety associated with the novel COVID-19 pandemic. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The CSS has 5 subscales: danger and contamination fears, fears about economic consequences, xenophobia, compulsive checking and traumatic stress symptoms.

Measure: COVID-19 Stress Scales (CSS)

Time: 8 weeks

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Description: Changes in pregnancy-specific anxiety will be assessed with the PRAQ-R2. Items are scored on 5-point Likert scale. Respondents are asked to circle the answer that applies most accurately to their situation and higher scores are reflective of greater pregnancy-specific anxiety. The PRAQ-R2 contains three subscales: fear of giving birth, worries about bearing a handicapped child, and concern about own appearance.

Measure: Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)

Time: 8 weeks

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Description: Changes in postpartum-specific anxiety will be assessed with the PSAS. Items are scored on a 4-point Likert scale (0-3), with higher scores indicating greater anxiety symptoms. The PSAS has 4 subscales: maternal competence and attachment, infant safety and welfare, practical infant care, and psychosocial adjustment to motherhood.

Measure: Postpartum Specific Anxiety Scale (PSAS)

Time: 8 weeks

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Description: Changes in severity and impairment associated with anxiety will be assessed with the OASIS. Respondents are asked to circle that answer that best describes their experience over the past week and items are scored on a 5-point Likert scale.

Measure: Overall Anxiety Severity and Impairment Scale (OASIS)

Time: 8 weeks

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Description: Changes in parenting self-efficacy will be assessed with the PSOC. The PSOC is a 17-item self-report scale, in which items are scored on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree), with higher scores reflecting greater parenting sense of competency.

Measure: Parenting Sense of Competence Scale (PSOC)

Time: 8 weeks

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Description: Changes in relationship satisfaction and adjustment will be assessed with the ADAS. The ADAS is a 7-item self-report scale, in which six of the items are scored on a 6-point Likert Scale, with higher scores reflecting greater relationship satisfaction. Item seven provides a global 'overall happiness' rating and is scored on 7-point Likert Scale ranging from 0 (extremely unhappy) to 6 (perfect).

Measure: Abbreviated Dyadic Adjustment Scale (ADAS)

Time: 8 weeks

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Description: Changes in perceived social support will be assessed with the SPS. Items are scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating higher levels of perceived social support. The SPS has 6 subscales assessing dimensions of attachment, social integration, reassurance of worth, guidance, nurturance and reliance.

Measure: Social Provisions Scale (SPS)

Time: 8 weeks

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Description: Changed in maternal attachment and bonding to the fetus will be assessed with the MAAS. For each item, respondents are asked to indicate the frequency in which each experience has occurred within the previous two weeks. The MAAS has two subscales that assess dimensions of quality of attachment and intensity of preoccupation. Items are scored on a 5-point Likert scale and scores range from 19 to 95 with higher scores indicating a higher level of attachment to the fetus.

Measure: Maternal Antenatal Attachment Scale (MAAS)

Time: 8 weeks

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Description: Changes in maternal bonding with the infant will be assessed with the PBQ. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), with higher scores indicating lower levels of bonding with the infant. The PBQ has four subscales: general bonding, rejection and pathological anger, anxiety about the infant, and incipient abuse.

Measure: Postpartum Bonding Questionnaire (PBQ)

Time: 8 weeks

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Description: Client satisfaction of the augmented CBT for perinatal anxiety during a global pandemic will be assessed with the CSQ. Items are scored on a 4-point Likert scale from 1 to 4, with higher scores indicating higher levels of satisfaction with services.

Measure: Client Satisfaction Questionnaire (CSQ)

Time: 8 weeks

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Description: Changes in participants perceived level of stress will be assessed with the PSS. The PSS is a 14-item self-report scale, with items scored on a 5-point Likert scale from 0 to 4, with higher total scores indicating higher perceived stress.

Measure: Perceived Stress Scale (PSS)

Time: 8 weeks

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Primary Outcomes

Description: The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.

Measure: Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes

Time: Baseline and at 15 minutes

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Primary Outcomes

Description: Assessed Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. Descriptive statistics is used to present the data.

Measure: Fear of COVID-19 infection

Time: 5th August 2020

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Description: Assessed Dental Anxiety among netizens in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale. Descriptive statistics is used to present the data.

Measure: Dental Anxiety

Time: 5th August 2020

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Description: The survey data is statistically analyzed to check for the correlation of the Fear of COVID-19 with Dental Anxiety among Netizens in Qassim region. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of Fear of COVID-19 infection & Dental Anxiety

Time: 5th August 2020

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Secondary Outcomes

Description: The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.

Time: 5th August 2020

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Description: The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the nearest Dental treatment seeking time and Dental Anxiety

Time: 5th August 2020

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Description: The survey data is statistically analyzed to check for the correlation of Age and Fear of COVID-19 infection The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 will be considered statistically significant correlation of the variables analysed.

Measure: Correlation of the Age and Fear of COVID-19 infection

Time: 5th August 2020

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Description: The survey data is statistically analyzed to check for the correlation of the Age and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the Age and Dental Anxiety.

Time: 5th August 2020

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