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

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757128
• Other study ID #: 063/2022
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: March 14, 2025

Study information

• Verified date: March 2024
• Source: Centre for Addiction and Mental Health
• Contact: Omair Husain, MBBS
• Phone: (416) 535-8501
• Email: omair.husain[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 14, 2025
• Est. primary completion date: September 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychosocial Functioning
• Psychotic Disorders

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. 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.

Locations

Country	Name	City	State
Canada	Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Self-report World Health Organization - Disability Assessment Schedule (WHO-DAS 2.0)	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.	baseline and post treatment (12 weeks after baseline)
Primary	Adherence	Percent sessions attended.	post treatment (12 weeks after baseline)
Primary	Retention rates	Percent participants who complete 12-week sessions.	post treatment (12 weeks after baseline)
Primary	Attrition	Percent participants that dropout at 12-weeks	post treatment (12 weeks after baseline)
Primary	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	Psychiatric diagnoses	Psychiatric diagnoses will be confirmed using the Structured Clinical Interview (SCID) for DSM-5.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)
Secondary	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.	baseline and post treatment (12 weeks after baseline)