Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

Study Overview
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Brief Summary
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This proposal aims to adapt an evidence-based comprehensive psychosocial and mental health support program, the Optimal Health Program (OHP), to improve functioning, reduce distress, and build resiliency in youth who are at clinical risk of developing psychosis (CHR). The main aims of the studies are 1).To adapt an existing, effective, validated psychological intervention for use in young people with CHR and offered virtually; 2).To evaluate the acceptability of OHP and the feasibility of conducting a clinical trial of OHP in individuals with CHR; 3)To assess the preliminary efficacy of OHP in enhancing resiliency, reducing depression and anxiety, and improving functioning in individuals with CHR in a single-arm exploratory clinical trial. Participants will be delivered OHP intervention over 12-weeks. Measures will be completed at study entry and repeated immediately post-treatment at 12-weeks.

Official Title
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Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

Conditions
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Psychosis, Psychosocial Functioning

Intervention / Treatment
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* Behavioral: Optimal Health Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 16-29 years old Being competent and willing to consent to study participation Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) either currently or at some point in the past 3 years. Exclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features) Intelligence quotient<70 and/or diagnosis of intellectual disability Severe developmental disorder Acute suicidality requiring immediate intervention

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>The single treatment arm will be administered optimal health program (OHP) intervention. | Behavioral: Optimal Health Program<br>* The OHP intervention will comprise a psychosocial management program that will be adapted to the CHR population and will be accompanied by a structured workbook, all accessed virtually through a web based digital portal. Sessions are approximately 1 hour in duration and held weekly for 6 weeks, and every two weeks for the remaining 6 weeks. The OHP has three components: 1) assessment and engagement; 2) therapy sessions, and 3) maintenance integration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Percent sessions attended. | post treatment (12 weeks after baseline) | 
| Retention rates | Percent participants who complete 12-week sessions. | post treatment (12 weeks after baseline) | 
| Attrition | Percent participants that dropout at 12-weeks | post treatment (12 weeks after baseline) | 
| Client Satisfaction Questionnaire | A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction. | post treatment (12 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric diagnoses | Psychiatric diagnoses will be confirmed using the Structured Clinical Interview (SCID) for DSM-5. | baseline and post treatment (12 weeks after baseline) | 
| Connor-Davidson Resilience Scale | This is a 25-item self-report rating scale designed to assess resilience, with higher scores indicating better outcome. Each item is rated on a 5-point scale ranging from not true at all or zero to true nearly all of the time or four. The total possible scores range from 0-100. | baseline and post treatment (12 weeks after baseline) | 
| Structured Interview for Prodromal Symptoms | The Structured Interview for Prodromal Symptoms (SIPS) is a widely used structured interview for diagnosing a CHR syndrome for psychosis and cases of first episode psychosis. It contains a severity rating scale (the Scale Of Psychosis-risk Symptoms, or SOPS). It is a 6-point scale, with higher scores indicating higher severity. | baseline and post treatment (12 weeks after baseline) | 
| Calgary Depression Scale for Schizophrenia | This scale measures the severity of depression symptoms. It is of a 4-point likert type scale with nine items with higher score indicating higher severity. | baseline and post treatment (12 weeks after baseline) | 
| State and trait anxiety inventory | This is a psychological inventory that measures anxiety. It consists of a 4-point likert scale with 40 items with higher scores indicating higher severity. | baseline and post treatment (12 weeks after baseline) | 
| Global Functioning: Social | This is a brief clinician-administered measures of social functioning, administered as a semi-structured interview with detailed anchors for ratings that address social functioning difficulties typically experienced by youth at risk for psychosis. Total possible scores on either scale ranges from 1 to 10, with higher scores indicating better social functioning. | baseline and post treatment (12 weeks after baseline) | 
| Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | The MCCB includes ten tests that assess seven cognitive domains: (1) Speed of Processing; (2) Attention/Vigilance; (3) Working Memory; (4) Verbal Learning; (5) Visual Learning; (6) Reasoning and Problem Solving; and (7) Social Cognition. Requires in person administration for standardization. The test generates a raw score and a T score. Higher scores indicate better cognitive performance. | baseline and post treatment (12 weeks after baseline) | 
| Global Functioning: Role | This is a brief clinician-administered measures of role functioning, administered as a semi-structured interview with detailed anchors for ratings that address role functioning difficulties typically experienced by youth at risk for psychosis. Total possible scores on either scale ranges from 1 to 10, with higher scores indicating better role functioning. | baseline and post treatment (12 weeks after baseline) |