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Completed

NCT Number: NCT05757128

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

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.

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Key information

Conditions

Psychosis Mental Disorders Psychosocial Functioning Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Diagnosis of intellectual disability previously documented in the patient chart
  • Severe developmental disorder
  • Acute suicidality requiring immediate intervention

Treatment and study plan

Optimal Health Program

Behavioral

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.

Primary outcomes

  1. Adherence

    Time frame: post treatment (12 weeks after baseline)

    Percent sessions attended.

  2. Retention rates

    Time frame: post treatment (12 weeks after baseline)

    Percent participants who complete 12-week sessions.

  3. Attrition

    Time frame: post treatment (12 weeks after baseline)

    Percent participants that dropout at 12-weeks

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2023
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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