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

Center for Addiction and Mental Health (CAMH)

Status: Completed

Conditions: Psychosis; Psychosocial Functioning

Treatments: Behavioral: Optimal Health Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05757128

063/2022

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 16 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

treatment arm

Experimental group

Description:

The single treatment arm will be administered optimal health program (OHP) intervention.

Treatment:

Behavioral: Optimal Health Program