Clinical trial NCT05757128: Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)
Official title: Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Psychosocial Functioning
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: post treatment (12 weeks after baseline)
measure: Retention rates
timeFrame: post treatment (12 weeks after baseline)
measure: Attrition
timeFrame: post treatment (12 weeks after baseline)
measure: Client Satisfaction Questionnaire
timeFrame: post treatment (12 weeks after baseline)
Secondary outcomes:
measure: Psychiatric diagnoses
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: Connor-Davidson Resilience Scale
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: Structured Interview for Prodromal Symptoms
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: Calgary Depression Scale for Schizophrenia
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: State and trait anxiety inventory
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: Global Functioning: Social
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline and post treatment (12 weeks after baseline)
measure: Global Functioning: Role
timeFrame: baseline and post treatment (12 weeks after baseline)
Other outcomes:
measure: The Self-report World Health Organization - Disability Assessment Schedule (WHO-DAS 2.0)
timeFrame: baseline and post treatment (12 weeks after baseline)
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: center of addiction and mental health
name: Omair Husain, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin A, Wood SJ, Nelson B, Beavan A, McGorry P, Yung AR. Outcomes of nontransitioned cases in a sample at ultra-high risk for psychosis. Am J Psychiatry. 2015 Mar 1;172(3):249-58. doi: 10.1176/appi.ajp.2014.13030418. Epub 2014 Nov 7.
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