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

March 12, 2024 updated by: Centre for Addiction and Mental Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Recruiting
        • Center for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment arm
The single treatment arm will be administered optimal health program (OHP) intervention.
Behavioral: Optimal Health Program
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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: post treatment (12 weeks after baseline)
Percent sessions attended.
post treatment (12 weeks after baseline)
Retention rates
Time Frame: post treatment (12 weeks after baseline)
Percent participants who complete 12-week sessions.
post treatment (12 weeks after baseline)
Attrition
Time Frame: post treatment (12 weeks after baseline)
Percent participants that dropout at 12-weeks
post treatment (12 weeks after baseline)
Client Satisfaction Questionnaire
Time Frame: post treatment (12 weeks after baseline)
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
Time Frame: baseline and post treatment (12 weeks after baseline)
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
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)
Structured Interview for Prodromal Symptoms
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)
Calgary Depression Scale for Schizophrenia
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)
State and trait anxiety inventory
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)
Global Functioning: Social
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)
Global Functioning: Role
Time Frame: 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.
baseline and post treatment (12 weeks after baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Self-report World Health Organization - Disability Assessment Schedule (WHO-DAS 2.0)
Time Frame: baseline and post treatment (12 weeks after baseline)
A 12-item generic assessment self-administered instrument for health and disability. It consists of a 5-point likert scale with higher scores indicating higher severity of disability.
baseline and post treatment (12 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Omair Husain, MBBS, center of addiction and mental health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Estimated)

September 14, 2024

Study Completion (Estimated)

March 14, 2025

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 063/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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