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

Not Applicable

Recruiting

• Conditions: Psychosocial Functioning; Psychosis
• Interventions: Behavioral: Optimal Health Program

• Registration Number: NCT05757128
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

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; 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Study Start: 2023-08-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-09-14
• Study Completion: 2025-03-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Be 16-29 years old
2. Being competent and willing to consent to study participation
3. 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

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
2. Diagnosis of intellectual disability previously documented in the patient chart
3. Severe developmental disorder
4. Acute suicidality requiring immediate intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Optimal Health Program	The single treatment arm will be administered optimal health program (OHP) intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Structured Interview for Prodromal Symptoms	baseline and post treatment (12 weeks after baseline)	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.
State and trait anxiety inventory	baseline and post treatment (12 weeks after baseline)	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.
Global Functioning: Social	baseline and post treatment (12 weeks after baseline)	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.
Psychiatric diagnoses	baseline and post treatment (12 weeks after baseline)	Psychiatric diagnoses will be confirmed using the Structured Clinical Interview (SCID) for DSM-5.
Connor-Davidson Resilience Scale	baseline and post treatment (12 weeks after baseline)	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.
Calgary Depression Scale for Schizophrenia	baseline and post treatment (12 weeks after baseline)	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.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)	baseline and post treatment (12 weeks after baseline)	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.
Global Functioning: Role	baseline and post treatment (12 weeks after baseline)	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.

Trial Locations

Locations (1)

Center for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada