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Clinical Trials/NCT05757128
NCT05757128
Completed
N/A

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

Centre for Addiction and Mental Health1 site in 1 country30 target enrollmentAugust 24, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosis
Sponsor
Centre for Addiction and Mental Health
Enrollment
30
Locations
1
Primary Endpoint
Adherence
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2023
End Date
December 19, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adherence

Time Frame: post treatment (12 weeks after baseline)

Percent sessions attended.

Retention rates

Time Frame: post treatment (12 weeks after baseline)

Percent participants who complete 12-week sessions.

Attrition

Time Frame: post treatment (12 weeks after baseline)

Percent participants that dropout at 12-weeks

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

  • Structured Interview for Prodromal Symptoms(baseline and post treatment (12 weeks after baseline))
  • State and trait anxiety inventory(baseline and post treatment (12 weeks after baseline))
  • Global Functioning: Social(baseline and post treatment (12 weeks after baseline))
  • Psychiatric diagnoses(baseline and post treatment (12 weeks after baseline))
  • Connor-Davidson Resilience Scale(baseline and post treatment (12 weeks after baseline))
  • Calgary Depression Scale for Schizophrenia(baseline and post treatment (12 weeks after baseline))
  • Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)(baseline and post treatment (12 weeks after baseline))
  • Global Functioning: Role(baseline and post treatment (12 weeks after baseline))

Study Sites (1)

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