Covid 19 Research using Clinical Trials (Home Page)
Report for D011618: Psychotic Disorders NIH
(Synonyms: Psychot, Psychotic Dis, Psychotic Disord, Psychotic Disorde, Psychotic Disorder, Psychotic Disorders)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2961 | pre_lunch Yoga-based breathing support Wiki | 0.50 |
| drug1725 | PACE-Life Wiki | 0.50 |
| drug2274 | Sleepio Wiki | 0.50 |
| drug2960 | pre_dinner Yoga-based breathing support Wiki | 0.50 |
| drug2899 | morning Yoga-based breathing support Wiki | 0.50 |
| drug882 | Exercise Intervention Wiki | 0.50 |
| drug2555 | Transitional Online Peer Support Group (n=24) Wiki | 0.50 |
| drug638 | Control Group (pharmacotherapy and/or psychotherapy, n=24) Wiki | 0.50 |
| drug2649 | Virtual ACT Workshop for Emotional Eating Wiki | 0.50 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders NIH | 0.50 |
| D001523 | Mental Disorders NIH | 0.43 |
| D012559 | Schizophrenia NIH | 0.29 |
| D007319 | Sleep Initiation and Maintenance Disorders NIH | 0.29 |
| D004194 | Disease NIH | 0.09 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000709 | Psychosis HPO | 1.00 |
| HP:0100785 | Insomnia HPO | 0.29 |
| HP:0100753 | Schizophrenia HPO | 0.29 |
There are 4 clinical trials
Clinical Trials
1 Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 56 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.
NCT04173572 Schizophrenia Schizoaffective Disorder Brief Psychotic Disorder Schizophreniform Disorders Unspecified Schizophrenia Spectrum and Other Psychotic Disorder Behavioral: PACE-Life Behavioral: Exercise Intervention MeSH:Disease Schizophrenia Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders
HPO:Psychosis Schizophrenia
Primary Outcomes
Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Measure: Difference in Participant's Total Distance During 6-minute Walk Time: Baseline and the last study visit (Up to 20 weeks)
Secondary Outcomes
Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Measure: Mean Difference in Minutes Spent Walking Time: Baseline and the last study visit (up to 20 weeks)
Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Measure: Mean Difference in Daily Steps Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Measure: Mean Difference Overall UCLA Loneliness Scale Score Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Measure: Mean Difference Overall PANSS Score Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).
Measure: Mean Difference in Body Weight Change Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).
Measure: Mean difference in blood pressure change Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).
Measure: Mean Difference in Resting Heart Rate Change Time: Baseline and the last study visit (Up to 20 weeks)
Other Outcomes
Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Measure: Mean Difference in Composite Score on the Autonomy Support Scale Time: Baseline and the last study visit (Up to 20 weeks)
Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Measure: End of Study Survey Time: Post treatment only (16 weeks)
2 Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)
Primary Outcomes
Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Measure: Difference in Participant's Total Distance During 6-minute Walk Time: Baseline and the last study visit (Up to 20 weeks)Secondary Outcomes
Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Measure: Mean Difference in Minutes Spent Walking Time: Baseline and the last study visit (up to 20 weeks)Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Measure: Mean Difference in Daily Steps Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Measure: Mean Difference Overall UCLA Loneliness Scale Score Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Measure: Mean Difference Overall PANSS Score Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).
Measure: Mean Difference in Body Weight Change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).
Measure: Mean difference in blood pressure change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).
Measure: Mean Difference in Resting Heart Rate Change Time: Baseline and the last study visit (Up to 20 weeks)Other Outcomes
Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Measure: Mean Difference in Composite Score on the Autonomy Support Scale Time: Baseline and the last study visit (Up to 20 weeks)Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Measure: End of Study Survey Time: Post treatment only (16 weeks)Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery. This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT). Cameo is a service for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their CAMEO team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.
NCT04180709 Psychotic Disorders Psychosis Sleep Device: Sleepio MeSH:Sleep Initiation and Maintenance Disorders Psychotic Disorders Mental Disorders
HPO:Insomnia Psychosis
Primary Outcomes
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study Time: Measure completed at baseline (start of week 1) and week 9.
Secondary Outcomes
Description: Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH).
Measure: Time Use Survey - Structured Hours (TUS-SH) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression.
Measure: Patient Health Questionnaire (PHQ-9) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of sustained attention.
Measure: Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of visual episodic memory.
Measure: Paired Associates Learning (PAL) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of working memory and strategy.
Measure: Spatial Working Memory (SWM) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of emotional recognition.
Measure: Emotion Recognition Task (ERT) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995).
Measure: Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S) Time: Measure completed in weeks 1, 9 and 17.
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17 Time: Measure completed at baseline (start of week 1) and week 17.
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis Time: Measure completed at baseline (start of week 1) and week 5.
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis Time: Measure completed at baseline (start of week 1) and week 13.
Other Outcomes
Description: SCI-8 this measure is validated against DSM-5 criteria for insomnia, including sleep quality and daytime function over the previous week. It is utilised within the Sleepio intervention and was the primary outcome measure for the OASIS randomised controlled trial (Freeman et al. 2017). This eight-item assessment questionnaire includes: 'concerns about getting to sleep, remaining asleep, sleep quality, daytime functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep'(Espie, Kyle, Hames, et al. 2014). It has a robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) (Espie, Kyle, Hames, et al. 2014). Scores range from 0-32 with higher scores indicating better sleep, scores below 17 identifying insomnia in 89% of cases (Espie, Kyle, Hames, et al. 2014; Freeman et al. 2017).
Measure: Sleep Condition Indicator (SCI-8) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: ISI is a measure specifically designed as a brief self-administered measure of insomnia and outcomes for use in their treatment within research. It corresponds to the DSM-IV criteria for insomnia and measures perception and severity of symptoms within the previous 2 weeks. Scores range from 0-28, 0-7 indicating no significant insomnia, 8-14 sub threshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia (Smith & Wegener 2003; Bastien et al. 2001). It has been validated as a web-based measure with internal consistency of ≥88% (Thorndike et al. 2011).
Measure: Insomnia Severity Index (ISI) Time: Measure completed in weeks 1, 9 and 17.
Description: PSQI is a self-report 19-item measure that retrospectively measures sleep quality and disturbances over the previous month. The domains of sleep quality included are: sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems and impact on daytime function. Scores range from 0-21, with higher scores indicating poorer sleep quality. The empirically derived cut-off score is >5 to distinguish poor sleepers with severe difficulties in at least 2 domains, or moderate difficulties in more than 3 domains. This cut-off correctly identifies 88.5% of patients, with a sensitivity of 89.6% and specificity of 86.5% (Buysse et al. 1989; Smith & Wegener 2003).
Measure: Pittsburgh Sleep Quality Index (PSQI) Time: Measure completed in weeks 1, 9 and 17.
Description: Nightly sleep diaries will be reported online using the Sleepio.com online diary.
GENEActive actigraphy watch will collect raw data of activity. Which will record sleep patterns objectively. This will be compared with sleep diaries for consistency of subjective measure with objective measure.
The actigraphy data will be considered for L5 (lowest 5 hours of activity) M10 (highest 10 hours of activity) and relative amplitude (ratio between L5 and M10). This will then be compared with the nightly sleep diaries for the same period to determine percentage of consistency of reporting.
Measure: Validation of Sleep Diaries by comparison with actigraphy activity data Time: Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period.
Description: This is a short 7 question (3 minute) survey to allow us to collect basic data on the impact of the ongoing pandemic on participants.
Measure: COVID-19 Brief Questionnaire (COVID-19-B) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
3 Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
Primary Outcomes
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study Time: Measure completed at baseline (start of week 1) and week 9.Secondary Outcomes
Description: Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH).
Measure: Time Use Survey - Structured Hours (TUS-SH) Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression.
Measure: Patient Health Questionnaire (PHQ-9) Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: iPad delivered cognitive test of sustained attention.
Measure: Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: iPad delivered cognitive test of visual episodic memory.
Measure: Paired Associates Learning (PAL) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: iPad delivered cognitive test of working memory and strategy.
Measure: Spatial Working Memory (SWM) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: iPad delivered cognitive test of emotional recognition.
Measure: Emotion Recognition Task (ERT) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995).
Measure: Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S) Time: Measure completed in weeks 1, 9 and 17.Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17 Time: Measure completed at baseline (start of week 1) and week 17.Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis Time: Measure completed at baseline (start of week 1) and week 5.Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis Time: Measure completed at baseline (start of week 1) and week 13.Other Outcomes
Description: SCI-8 this measure is validated against DSM-5 criteria for insomnia, including sleep quality and daytime function over the previous week. It is utilised within the Sleepio intervention and was the primary outcome measure for the OASIS randomised controlled trial (Freeman et al. 2017). This eight-item assessment questionnaire includes: 'concerns about getting to sleep, remaining asleep, sleep quality, daytime functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep'(Espie, Kyle, Hames, et al. 2014). It has a robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) (Espie, Kyle, Hames, et al. 2014). Scores range from 0-32 with higher scores indicating better sleep, scores below 17 identifying insomnia in 89% of cases (Espie, Kyle, Hames, et al. 2014; Freeman et al. 2017).
Measure: Sleep Condition Indicator (SCI-8) Time: Measure completed in weeks 1, 5, 9, 13 and 17.Description: ISI is a measure specifically designed as a brief self-administered measure of insomnia and outcomes for use in their treatment within research. It corresponds to the DSM-IV criteria for insomnia and measures perception and severity of symptoms within the previous 2 weeks. Scores range from 0-28, 0-7 indicating no significant insomnia, 8-14 sub threshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia (Smith & Wegener 2003; Bastien et al. 2001). It has been validated as a web-based measure with internal consistency of ≥88% (Thorndike et al. 2011).
Measure: Insomnia Severity Index (ISI) Time: Measure completed in weeks 1, 9 and 17.Description: PSQI is a self-report 19-item measure that retrospectively measures sleep quality and disturbances over the previous month. The domains of sleep quality included are: sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems and impact on daytime function. Scores range from 0-21, with higher scores indicating poorer sleep quality. The empirically derived cut-off score is >5 to distinguish poor sleepers with severe difficulties in at least 2 domains, or moderate difficulties in more than 3 domains. This cut-off correctly identifies 88.5% of patients, with a sensitivity of 89.6% and specificity of 86.5% (Buysse et al. 1989; Smith & Wegener 2003).
Measure: Pittsburgh Sleep Quality Index (PSQI) Time: Measure completed in weeks 1, 9 and 17.Description: Nightly sleep diaries will be reported online using the Sleepio.com online diary. GENEActive actigraphy watch will collect raw data of activity. Which will record sleep patterns objectively. This will be compared with sleep diaries for consistency of subjective measure with objective measure. The actigraphy data will be considered for L5 (lowest 5 hours of activity) M10 (highest 10 hours of activity) and relative amplitude (ratio between L5 and M10). This will then be compared with the nightly sleep diaries for the same period to determine percentage of consistency of reporting.
Measure: Validation of Sleep Diaries by comparison with actigraphy activity data Time: Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period.Description: This is a short 7 question (3 minute) survey to allow us to collect basic data on the impact of the ongoing pandemic on participants.
Measure: COVID-19 Brief Questionnaire (COVID-19-B) Time: Measure completed in weeks 1, 5, 9, 13 and 17.COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.
NCT04413747 Coronavirus Infection Cytokine Storm Mental Disorder Behavioral: morning Yoga-based breathing support Behavioral: pre_lunch Yoga-based breathing support Behavioral: pre_dinner Yoga-based breathing support MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Mental Disorders Psychotic Disorders
HPO:Psychosis
Primary Outcomes
Description: COVID-19's Patients mortality all cause: incidence proportion.
Measure: Mortality Time: 12 months.
Description: COVID-19's Patients suicide: incidence proportion.
Measure: Mortality-suicide Time: 12 months.
Secondary Outcomes
Description: In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -
Measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients- Time: 1 months.
Description: Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
Measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder. Time: 12 months.
Description: Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.
Measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II). Time: 12 months.
Description: Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.
Measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI). Time: 12 months.
4 Effects of Online and Recovery-oriented Peer Support Groups Facilitated by Peer Support Workers in Times of COVID-19 : A Feasibility Study of a Trial
Primary Outcomes
Description: COVID-19's Patients mortality all cause: incidence proportion.
Measure: Mortality Time: 12 months.Description: COVID-19's Patients suicide: incidence proportion.
Measure: Mortality-suicide Time: 12 months.Secondary Outcomes
Description: In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -
Measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients- Time: 1 months.Description: Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
Measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder. Time: 12 months.Description: Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.
Measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II). Time: 12 months.Description: Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.
Measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI). Time: 12 months.In times of pandemics, social distancing, isolation and quarantine exacerbate depression and anxiety as confined people are detached from their loved ones, deprived of personal liberties, and devoid of purpose owing to altered routine and livelihood (1,2). Those with pre-existing mental health problems or illnesses (MHPIs) might suffer from limiting interpersonal interactions that are central to their self-management, as well as reduced access to helpful but "non-essential" (often cancelled) psychiatric services (3). In response to this situation, this feasibility study of a trial consists of offering a transitional measure of online peer support for people suffering from (a) psychotic disorders or (b) anxiety and mood disorders, and to determine an effect size to this Peer Support Workers-delivered intervention in terms of both personal-civic recovery and clinical recovery (4). Peer Support Workers (PSWs) are persons with first-hand lived experience of MHPIs, and who are further along in their own recovery journey. As recommended by recovery-oriented best practices guidelines (5,6), upon training and certification they can provide supportive services when hired to fill such a paid specialty position directly in, or in conjunction with, current psychiatric services. Indeed, recovery focuses on how individuals can have more active control over their lives (agency). It is characterized by a search for the person's strengths and capacities, satisfying and meaningful social roles, and mobilizing formal and informal support systems. Peer support has thus become one predominant concept in the recovery paradigm and PSWs are specialized in peer support. Yet, not much is known about the efficacy of PSWs from a consumer's perspective of personal-civic recovery. The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery potential and (Q2) clinical recovery potential, (Q3) how these potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of people in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.
NCT04445324 Psychotic Disorders Anxiety Depression Behavioral: Transitional Online Peer Support Group (n=24) Other: Control Group (pharmacotherapy and/or psychotherapy, n=24) MeSH:Mental Disorders Psychotic Disorders
HPO:Psychosis
Primary Outcomes
Description: Recovery Assesment Scale (RAS). This is a 24-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery. Minimum score = 24 : maximum score = 120.
Measure: Assessment of patients' current status : recovery (personal recovery) Time: 12 weeks
Description: Participating patients will fill out the Citizenship Measure (CM). This is a 23-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of citizenship. Minimum score = 23 : maximum score = 115.
Measure: Assessment of patients' current status : citizenship (personal recovery) Time: 12 weeks
Description: Participating with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of COVID-related levels of stress. Minimum score = 0 : maximum score = 144.
Measure: Assessment of patients' current status : COVID-19 Stress Scales Time: 12 weeks
Secondary Outcomes
Description: Participating patients will fill out the Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6). This is a 6-item questionnaire with 4-point Likert scales (1-2-3-4). Higher scores are positively correlated with higher levels of anxiety. Minimum score = 6 : maximum score = 24.
Measure: Assessment of patients' current status : anxiety (clinical recovery) Time: 12 weeks
Description: Participating patients will fill out the Depression Patient Health Questionnaire (PHQ-9). This is a 9-item questionnaire with 4-point Likert scales (0-1-2-3). Higher scores are positively correlated with higher levels of depression. Minimum score = 0 : maximum score = 27.
Measure: Assessment of patients' current status : depression (clinical recovery) Time: 12 weeks
Description: Participating patients will fill out the Alcohol Use Disorders Identification Test (AUDIT-10). This is a 10-item questionnaire with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of alcohol dependence. Minimum score = 0 : maximum score = 40.
Measure: Assessment of patients' current status : alcohol dependence (clinical recovery) Time: 12 weeks
Description: Participating patients will fill out the Drug Abuse Screening Test (DAST-10). This is a 10-item questionnaire with noyes answers (0-1). Higher scores are positively correlated with higher levels of drog dependence. Minimum score = 0 : maximum score = 10.
Measure: Assessment of patients' current status : drug dependence (clinical recovery) Time: 12 weeks
Description: Psychosis Screening Questionnaire (PSQ 12 items) with no-unsure-yes answers (1-2-3). Higher scores are positively correlated with higher levels of psychosis. Minimum score = 12 : maximum score = 36.
Measure: Assessment of patients' current status : psychosis (clinical recovery) Time: 12 weeks
Description: Participating patients will fill out the World Health Organization Disability Assessment Schedule (WHODAS 2.0). This is a 12-item questionnaire with 5-point Likert scales (0-1-2-3-4). Lower scores are positively correlated with higher levels of social functioning. Minimum score = 0 : maximum score = 48.
Measure: Assessment of patients' current status : social functioning (clinical recovery) Time: 12 weeks
HPO Nodes
HP:0000709: Psychosis
Genes 115
MKRN3-AS1 ALAD PDGFRB C9ORF72 SH2B1 TTC19 FCGR2B SLC25A13 CTLA4 ACADS MYORG HFE PDGFB GRN PRDM8 CACNA1A TRNF SOBP UPF3B GSS ALDH5A1 SNRPN PWAR1 STAT4 TBC1D7 ZFYVE26 MECP2 CBS EPM2A MED12 ATP13A2 ND1 ND4 PDGFB USP8 SLC6A19 CDH23 VPS13A COX1 SPART SQSTM1 TWNK ITM2B TRNW NPAP1 MKRN3 TRNQ DNMT1 ND5 PRKAR1A ABCD1 GCLC SLC7A7 IRAK1 PRNP CLN8 ND6 PCDH19 PPOX NPC2 SLC12A6 SNORD116-1 PARK7 ATXN7 MAPT SLC20A2 PAK3 NDP COX3 HMBS KCNT1 WFS1 DNASE1 AIP TMEM106B ALDH18A1 PCDH19 PWRN1 PSEN1 NDN COX2 C9ORF72 RPS6KA3 PDE11A TRNS2 WFS1 TREM2 NDP CHMP2B PUS3 PTPN22 SPP1 IPW DCAF17 DCAF17 LMBRD1 HERC2 ZDHHC9 TREX1 CLN3 NHLRC1 TRNS1 MAGEL2 PANK2 GNAS TRNL1 FCGR2A TRNH VCP NAGS USP8 SNORD115-1 NPC1 MED12 PAH
Primary Outcomes
Description: Recovery Assesment Scale (RAS). This is a 24-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery. Minimum score = 24 : maximum score = 120.
Measure: Assessment of patients' current status : recovery (personal recovery) Time: 12 weeksDescription: Participating patients will fill out the Citizenship Measure (CM). This is a 23-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of citizenship. Minimum score = 23 : maximum score = 115.
Measure: Assessment of patients' current status : citizenship (personal recovery) Time: 12 weeksDescription: Participating with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of COVID-related levels of stress. Minimum score = 0 : maximum score = 144.
Measure: Assessment of patients' current status : COVID-19 Stress Scales Time: 12 weeksSecondary Outcomes
Description: Participating patients will fill out the Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6). This is a 6-item questionnaire with 4-point Likert scales (1-2-3-4). Higher scores are positively correlated with higher levels of anxiety. Minimum score = 6 : maximum score = 24.
Measure: Assessment of patients' current status : anxiety (clinical recovery) Time: 12 weeksDescription: Participating patients will fill out the Depression Patient Health Questionnaire (PHQ-9). This is a 9-item questionnaire with 4-point Likert scales (0-1-2-3). Higher scores are positively correlated with higher levels of depression. Minimum score = 0 : maximum score = 27.
Measure: Assessment of patients' current status : depression (clinical recovery) Time: 12 weeksDescription: Participating patients will fill out the Alcohol Use Disorders Identification Test (AUDIT-10). This is a 10-item questionnaire with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of alcohol dependence. Minimum score = 0 : maximum score = 40.
Measure: Assessment of patients' current status : alcohol dependence (clinical recovery) Time: 12 weeksDescription: Participating patients will fill out the Drug Abuse Screening Test (DAST-10). This is a 10-item questionnaire with noyes answers (0-1). Higher scores are positively correlated with higher levels of drog dependence. Minimum score = 0 : maximum score = 10.
Measure: Assessment of patients' current status : drug dependence (clinical recovery) Time: 12 weeksDescription: Psychosis Screening Questionnaire (PSQ 12 items) with no-unsure-yes answers (1-2-3). Higher scores are positively correlated with higher levels of psychosis. Minimum score = 12 : maximum score = 36.
Measure: Assessment of patients' current status : psychosis (clinical recovery) Time: 12 weeksDescription: Participating patients will fill out the World Health Organization Disability Assessment Schedule (WHODAS 2.0). This is a 12-item questionnaire with 5-point Likert scales (0-1-2-3-4). Lower scores are positively correlated with higher levels of social functioning. Minimum score = 0 : maximum score = 48.
Measure: Assessment of patients' current status : social functioning (clinical recovery) Time: 12 weeks