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    HP:0000709: Psychosis

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (16)


    Name (Synonyms) Correlation
    drug3231 RO6889450 Wiki 0.50
    drug1395 Enhanced supervised fitness training Wiki 0.35
    drug3379 Risperidone Wiki 0.35
    Name (Synonyms) Correlation
    drug4667 pre_lunch Yoga-based breathing support Wiki 0.35
    drug4589 morning Yoga-based breathing support Wiki 0.35
    drug3645 Sleepio Wiki 0.35
    drug4071 Transitional Online Peer Support Group (n=20) Wiki 0.35
    drug4666 pre_dinner Yoga-based breathing support Wiki 0.35
    drug2844 Peer Education on Exercise for Recovery Wiki 0.35
    drug1034 Control Group (pharmacotherapy and/or psychotherapy, n=10) Wiki 0.35
    drug2750 PACE-Life Wiki 0.35
    drug4281 Waiting list Wiki 0.35
    drug1438 Exercise Intervention Wiki 0.35
    drug2355 Metacognitive therapy and work-focused interventions Wiki 0.35
    drug3040 Povidone-Iodine Wiki 0.18
    drug2916 Placebo Wiki 0.03

    Correlated MeSH Terms (8)


    Name (Synonyms) Correlation
    D011618 Psychotic Disorders NIH 1.00
    D012559 Schizophrenia NIH 0.47
    D001523 Mental Disorders NIH 0.42
    Name (Synonyms) Correlation
    D019967 Schizophrenia Spectrum and Other Psychotic Disorders NIH 0.35
    D007319 Sleep Initiation and Maintenance Disorders NIH 0.18
    D004194 Disease NIH 0.06
    D045169 Severe Acute Respiratory Syndrome NIH 0.02
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0100753 Schizophrenia HPO 0.47
    HP:0100785 Insomnia HPO 0.18

    Clinical Trials

    Navigate: Correlations   HPO

    There are 8 clinical trials


    1 Peer Support for Exercise in Older Veterans With Psychotic Disorders

    Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing homes. These challenges make it difficult for this group to engage in health behaviors, such as exercise. This is unfortunate, since participation in health-promoting activities is essential for maintaining functional independence with age. This study aims to develop and pilot test a peer coaching intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans in recovery from mental illness, will provide intensive coaching to older Veterans with psychotic disorders to promote their participation in exercise and physical activity. Results from this study will inform us as to whether this intervention is acceptable to Veterans, feasible to implement, and effective in increasing exercise, physical activity, and physical fitness/function.

    NCT02958007
    Conditions
    1. Psychotic Disorder
    Interventions
    1. Behavioral: Peer Education on Exercise for Recovery
    2. Behavioral: Enhanced supervised fitness training
    MeSH:Mental Disorders Psychotic Disorders
    HPO:Psychosis

    Primary Outcomes

    Description: Percent of participants randomized to PEER who attend at least three group sessions

    Measure: Intervention engagement

    Time: 12 weeks

    Description: Percent of sampled PEER group sessions in which the peer coaches were adequately adherent (i.e., average score equal to "acceptable" and no items scored as "unacceptable") on the PEER fidelity measure

    Measure: Intervention fidelity

    Time: 12 weeks

    Description: Attendance- mean number of supervised fitness training sessions attended

    Measure: Attendance- mean number of supervised fitness training sessions attended

    Time: 12 weeks

    Description: Weekly step-counts will be measured by pedometer

    Measure: Change from baseline in Ambulatory Physical Activity

    Time: 12 weeks

    Description: Maximum rate of oxygen consumption as measured during incremental exercise on a motorized treadmill

    Measure: Change from baseline in Maximal Aerobic Capacity (Vo2Max)

    Time: 12 weeks
    2 Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders: A Randomized Waiting List Controlled Trial

    Common mental health disorders such as anxiety and depression are leading causes of sickness absence and disability in Norway. Despite tremendous costs for individual and society, effective treatment is lacking. Mental health interventions do not typically target work situation, despite its importance for patient well-being. On a policy level, effective measures are impeded by a paucity of scientific data, and programs designed to address the issue such as Faster Return to Work ("Raskere tilbake") lack evaluation. The present project will test the effectiveness of Metacognitive therapy and work-focused interventions for reducing sick leave in patients with common mental disorders.

    NCT03301922
    Conditions
    1. Anxiety
    2. Depression
    Interventions
    1. Behavioral: Metacognitive therapy and work-focused interventions
    2. Other: Waiting list
    MeSH:Mental Disorders Psychotic Disorders
    HPO:Psychosis

    Primary Outcomes

    Description: data from National registers

    Measure: Changes in degree of sick leave

    Time: From 2 years prior to intervention - to 4 years after intervention

    Description: data from patients self-report

    Measure: Changes in degree of sick leave

    Time: From 2 years prior to intervention - to 4 years after intervention

    Description: Changes in depressive symptoms measured by Beck Anxiety Inventory (BAI)

    Measure: Changes in anxiety symptoms

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Changes in depressive symptoms measured by Beck Depression Inventory II (BDI-II)

    Measure: Changes in depressive symptoms

    Time: From pre treatment, to post treatment (12 weeks), 6 months 1 year follow-up

    Secondary Outcomes

    Description: Changes in metacognitions symptoms measured by the Metacognitions Questionnaire 30 (MCQ-30)

    Measure: Changes in metacognitions

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Changes in symptoms measured by Subjective Health Complaints

    Measure: Changes in subjective health complaints

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Changes in measured Negative Acts Questionnaire

    Measure: Changes in bullying and victimisation at work

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Changes measured with Return to work self-efficacy

    Measure: Changes in self-efficacy

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Changes measured with The resilience scale for adults (RSA)

    Measure: Changes in resilience

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Changes measured with EQ-5D-5L

    Measure: Changes in quality of life

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up

    Description: Diagnostic evaluations using MINI - International Neuropsychiatric Interview

    Measure: MINI - diagnostic interview

    Time: From pre treatment, to post treatment (12 weeks)

    Other Outcomes

    Description: Sub-analyses taking into consideration the onset of Covid-19 in Norway by mid March 2020

    Measure: Secondary analysis related to the onset of Covid-19

    Time: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
    3 Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

    This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.

    NCT03669640
    Conditions
    1. Schizophrenia, Schizoaffective Disorder
    Interventions
    1. Drug: RO6889450
    2. Drug: Placebo
    MeSH:Schizophrenia Psychotic Disorders
    HPO:Psychosis Schizophrenia

    Primary Outcomes

    Measure: Change from Baseline at Week 12 in Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore

    Time: Baseline to Week 12

    Secondary Outcomes

    Measure: Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in CGI-S Negative Symptoms Scores

    Time: Baseline to week 12

    Measure: Clinical Global Impression - Improvement (CGI-I) Overall Scores

    Time: Week 12

    Measure: CGI-I Negative Symptoms Scores

    Time: Week 12

    Measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Symptom Factor Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Defeatist Performance Attitude Scale (DPAS) Scores

    Time: Baseline to week 12

    Measure: Percentage of Participants with Adverse Events (AE)

    Time: Baseline through the end of the follow-up period (approximately 16 weeks)

    Measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Scores

    Time: Baseline through the end of the follow-up period (approximately 16 weeks)

    Measure: Change from Baseline in Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)

    Time: Baseline through the end of the follow-up period (approximately 16 weeks)

    Measure: Area Under the Curve at Steady State (AUCss) of RO6889450

    Time: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks)

    Measure: Maximum Serum Concentration (Cmax) of RO6889450

    Time: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks)
    4 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
    Conditions
    1. Schizophrenia
    2. Schizoaffective Disorder
    3. Brief Psychotic Disorder
    4. Schizophreniform Disorders
    5. Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
    Interventions
    1. Behavioral: PACE-Life
    2. 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)
    5 Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)

    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
    Conditions
    1. Psychotic Disorders
    2. Psychosis
    3. Sleep
    Interventions
    1. 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.
    6 Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19

    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
    Conditions
    1. Coronavirus Infection
    2. Cytokine Storm
    3. Mental Disorder
    Interventions
    1. Behavioral: morning Yoga-based breathing support
    2. Behavioral: pre_lunch Yoga-based breathing support
    3. 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.
    7 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

    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
    Conditions
    1. Psychotic Disorders
    2. Anxiety Depression
    Interventions
    1. Behavioral: Transitional Online Peer Support Group (n=20)
    2. Other: Control Group (pharmacotherapy and/or psychotherapy, n=10)
    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
    8 A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

    This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.

    NCT04512066
    Conditions
    1. Schizophrenia, Schizoaffective Disorder
    Interventions
    1. Drug: RO6889450
    2. Drug: Placebo
    3. Drug: Risperidone
    MeSH:Schizophrenia Psychotic Disorders
    HPO:Psychosis Schizophrenia

    Primary Outcomes

    Measure: Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

    Time: Baseline to Week 4

    Secondary Outcomes

    Measure: Proportion of Participants with at least 20% or 50% Improvement from Baseline in the PANSS Total Score

    Time: Baseline to Week 12

    Measure: Change from Baseline in the PANSS Factor Scores

    Time: Baseline to Week 12

    Measure: Proportion of Participants with at Least 20% or 50% Improvement in the PANSS Factor Scores

    Time: Baseline to Week 12

    Measure: Change from Baseline in Clinical Global Impression Severity (CGI-S) Scores

    Time: Baseline to Week 12

    Measure: Clinical Global Impression - Improvement (CGI-I) Scores

    Time: Baseline to Week 12

    Measure: Clinical Global Impression - Improvement Most Troubling Symptoms (CGI-I MTS)

    Time: Baseline to Week 12

    Measure: Change from Baseline in Clinical Global Impression - Severity Most Troubling Symptoms (CGI-S MTS)

    Time: Baseline to Week 12

    Measure: Time from First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ)

    Time: Baseline to Week 4

    Measure: Percentage of Participants with Adverse Events (AEs)

    Time: Baseline to Week 12

    Measure: Change from Baseline in Electrocardiogram (ECG) Intervals

    Time: Baseline to Week 12

    Measure: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time: Baseline to Week 12

    Measure: Change from Baseline in Extrapyramidal Symptom Rating Scale (ESRS-A)

    Time: Baseline to Week 12

    Measure: Maximum Concentration (Cmax) of RO6889450

    Time: Baseline to Week 12

    Measure: Area Under the Concentration-Time Curve at Steady State (AUCss) of RO6889450

    Time: Baseline to Week 4

    HPO Nodes


    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,180 reports on interventions/drugs

    MeSH

    691 reports on MeSH terms

    HPO

    263 reports on HPO terms

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    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook