Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: treatment arm The single treatment arm will be administered optimal health program (OHP) intervention. |
Behavioral: Optimal Health Program
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.
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Outcome Measures
Primary Outcome Measures
- Adherence [post treatment (12 weeks after baseline)]
Percent sessions attended.
- Retention rates [post treatment (12 weeks after baseline)]
Percent participants who complete 12-week sessions.
- Attrition [post treatment (12 weeks after baseline)]
Percent participants that dropout at 12-weeks
- Client Satisfaction Questionnaire [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 Outcome Measures
- Psychiatric diagnoses [baseline and post treatment (12 weeks after baseline)]
Psychiatric diagnoses will be confirmed using the Structured Clinical Interview (SCID) for DSM-5.
- Connor-Davidson Resilience Scale [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.
- Structured Interview for Prodromal Symptoms [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.
- Calgary Depression Scale for Schizophrenia [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.
- State and trait anxiety inventory [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.
- Global Functioning: Social [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.
- Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) [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.
- Global Functioning: Role [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be 16-29 years old
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Being competent and willing to consent to study participation
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Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS)
Exclusion Criteria:
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Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
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Intelligence quotient<70 and/or diagnosis of intellectual disability
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Severe developmental disorder
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Acute suicidality requiring immediate intervention
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre for Addiction and Mental Health
Investigators
- Principal Investigator: Omair Husain, MBBS, center of addiction and mental health
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Henderson J, Courey L, Relihan J, Darnay K, Szatmari P, Cleverley K, Cheung A, Hawke LD. Youth and family members make meaningful contributions to a randomized-controlled trial: YouthCan IMPACT. Early Interv Psychiatry. 2022 Jun;16(6):670-677. doi: 10.1111/eip.13232. Epub 2021 Nov 1.
- Knowles SR, Ski CF, Langham R, O'Flaherty E, Thompson DR, Rossell SL, Moore G, Hsueh YS, Castle DJ. Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial. Trials. 2016 Sep 9;17(1):447. doi: 10.1186/s13063-016-1558-z.
- 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.
- 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.
- 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. Erratum In: Schizophr Bull. 2004;30(2):following 217.
- 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.
- 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.
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