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

NCT05757128 | Completed DMC

• 1 other identifier: 063/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Psychosocial Functioning

Outcome Measures

Primary Outcomes (4)

• Adherence

  Percent sessions attended.

  post treatment (12 weeks after baseline)

• Retention rates

  Percent participants who complete 12-week sessions.

  post treatment (12 weeks after baseline)

• Attrition

  Percent participants that dropout at 12-weeks

  post treatment (12 weeks after baseline)

• Client Satisfaction Questionnaire

  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 Outcomes (8)

• Psychiatric diagnoses

  baseline and post treatment (12 weeks after baseline)

• Connor-Davidson Resilience Scale

  baseline and post treatment (12 weeks after baseline)

• Structured Interview for Prodromal Symptoms

  baseline and post treatment (12 weeks after baseline)

• Calgary Depression Scale for Schizophrenia

  baseline and post treatment (12 weeks after baseline)

• State and trait anxiety inventory

  baseline and post treatment (12 weeks after baseline)

Other Outcomes (1)

• The Self-report World Health Organization - Disability Assessment Schedule (WHO-DAS 2.0)

  baseline and post treatment (12 weeks after baseline)

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Behavioral: Optimal Health Program

Interventions

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.

treatment arm

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (13)

• 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.

  PMID: 25727537 BACKGROUND

• 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.

  PMID: 25298008 BACKGROUND

• 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.

  PMID: 23180756 BACKGROUND

• Alvarez-Jimenez M, Gleeson JF, Henry LP, Harrigan SM, Harris MG, Killackey E, Bendall S, Amminger GP, Yung AR, Herrman H, Jackson HJ, McGorry PD. Road to full recovery: longitudinal relationship between symptomatic remission and psychosocial recovery in first-episode psychosis over 7.5 years. Psychol Med. 2012 Mar;42(3):595-606. doi: 10.1017/S0033291711001504. Epub 2011 Aug 19.

  PMID: 21854682 BACKGROUND

• 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.

  PMID: 29856558 BACKGROUND

• Devoe DJ, Farris MS, Townes P, Addington J. Interventions and social functioning in youth at risk of psychosis: A systematic review and meta-analysis. Early Interv Psychiatry. 2019 Apr;13(2):169-180. doi: 10.1111/eip.12689. Epub 2018 Jun 25.

  PMID: 29938910 BACKGROUND

• Beck K, Andreou C, Studerus E, Heitz U, Ittig S, Leanza L, Riecher-Rossler A. Clinical and functional long-term outcome of patients at clinical high risk (CHR) for psychosis without transition to psychosis: A systematic review. Schizophr Res. 2019 Aug;210:39-47. doi: 10.1016/j.schres.2018.12.047. Epub 2019 Jan 14.

  PMID: 30651204 BACKGROUND

• Gilbert MM, Chamberlain JA, White CR, Mayers PW, Pawsey B, Liew D, Musgrave M, Crawford K, Castle DJ. Controlled clinical trial of a self-management program for people with mental illness in an adult mental health service - the Optimal Health Program (OHP). Aust Health Rev. 2012 Feb;36(1):1-7. doi: 10.1071/AH11008.

  PMID: 22513012 BACKGROUND

• Pytel' AIa, Goligorskii SD. [Treatment of chronic pyelonephritis]. Sov Med. 1972 Mar;35(3):7-13. No abstract available. Russian.

  PMID: 5018180 BACKGROUND

• Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.

  PMID: 34593508 BACKGROUND

• Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.

  PMID: 14989408 BACKGROUND

• Major BJ, Busuttil BE, Frauman AG. Graves' ophthalmopathy: pathogenesis and clinical implications. Aust N Z J Med. 1998 Feb;28(1):39-45. doi: 10.1111/j.1445-5994.1998.tb04457.x. No abstract available.

  PMID: 9544385 BACKGROUND

• Husain MO, Hawke LD, Lu Y, Kozloff N, Strudwick G, Kiang M, Wang W, Castle D, Foussias G. A mixed-methods study to evaluate the feasibility and preliminary efficacy of delivering the optimal health program (OHP) for youth at clinical high risk (CHR) for psychosis: A study protocol. PLoS One. 2024 Jul 18;19(7):e0306968. doi: 10.1371/journal.pone.0306968. eCollection 2024.

  PMID: 39024237 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Omair Husain, MBBS

  center of addiction and mental health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 7, 2023
• Study Start: August 24, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)