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

Primary Purpose

Psychosis, Psychosocial Functioning

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Optimal Health Program
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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) Intelligence quotient<70 and/or diagnosis of intellectual disability Severe developmental disorder Acute suicidality requiring immediate intervention

Sites / Locations

  • Center for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

Adherence
Percent sessions attended.
Retention rates
Percent participants who complete 12-week sessions.
Attrition
Percent participants that dropout at 12-weeks
Client Satisfaction Questionnaire
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.

Secondary Outcome Measures

Psychiatric diagnoses
Psychiatric diagnoses will be confirmed using the Structured Clinical Interview (SCID) for DSM-5.
Connor-Davidson Resilience Scale
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.
Structured Interview for Prodromal Symptoms
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.
Calgary Depression Scale for Schizophrenia
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.
State and trait anxiety inventory
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.
Global Functioning: Social
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.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
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.
Global Functioning: Role
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.

Full Information

First Posted
January 26, 2023
Last Updated
August 28, 2023
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05757128
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Anticipated)
Primary Completion Date
September 14, 2024 (Anticipated)
Study Completion Date
March 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 and offered virtually; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Psychosocial Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
The single treatment arm will be administered optimal health program (OHP) intervention.
Intervention Type
Behavioral
Intervention Name(s)
Optimal Health Program
Intervention Description
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, all accessed virtually through a web based digital portal. 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 Outcome Measure Information:
Title
Adherence
Description
Percent sessions attended.
Time Frame
post treatment (12 weeks after baseline)
Title
Retention rates
Description
Percent participants who complete 12-week sessions.
Time Frame
post treatment (12 weeks after baseline)
Title
Attrition
Description
Percent participants that dropout at 12-weeks
Time Frame
post treatment (12 weeks after baseline)
Title
Client Satisfaction Questionnaire
Description
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
Time Frame
post treatment (12 weeks after baseline)
Secondary Outcome Measure Information:
Title
Psychiatric diagnoses
Description
Psychiatric diagnoses will be confirmed using the Structured Clinical Interview (SCID) for DSM-5.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
Connor-Davidson Resilience Scale
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
Structured Interview for Prodromal Symptoms
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
Calgary Depression Scale for Schizophrenia
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
State and trait anxiety inventory
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
Global Functioning: Social
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Title
Global Functioning: Role
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
The Self-report World Health Organization - Disability Assessment Schedule (WHO-DAS 2.0)
Description
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.
Time Frame
baseline and post treatment (12 weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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) Intelligence quotient<70 and/or diagnosis of intellectual disability Severe developmental disorder Acute suicidality requiring immediate intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omair Husain, MBBS
Phone
(416) 535-8501
Ext
36467
Email
omair.husain@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omair Husain, MBBS
Organizational Affiliation
center of addiction and mental health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25727537
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.
Results Reference
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25298008
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Taylor PJ, Hutton P, Wood L. Are people at risk of psychosis also at risk of suicide and self-harm? A systematic review and meta-analysis. Psychol Med. 2015 Apr;45(5):911-26. doi: 10.1017/S0033291714002074. Epub 2014 Oct 9.
Results Reference
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PubMed Identifier
23180756
Citation
Fusar-Poli P, Nelson B, Valmaggia L, Yung AR, McGuire PK. Comorbid depressive and anxiety disorders in 509 individuals with an at-risk mental state: impact on psychopathology and transition to psychosis. Schizophr Bull. 2014 Jan;40(1):120-31. doi: 10.1093/schbul/sbs136. Epub 2012 Nov 22.
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PubMed Identifier
29856558
Citation
McGorry PD, Hartmann JA, Spooner R, Nelson B. Beyond the "at risk mental state" concept: transitioning to transdiagnostic psychiatry. World Psychiatry. 2018 Jun;17(2):133-142. doi: 10.1002/wps.20514.
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Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

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