Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program

Official title

Evaluating the Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program for Adults With Recent-onset Psychosis: A Randomized Controlled Trial

Overview

Psychosis is a very disabling mental illness with a wide range of dysregulations and disruptions in cognition, emotions, and behaviors, resulting in poor functioning and frequent relapses, especially in the first five years of the illness. There is a knowledge gap about whether Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) can have longer-term and more significant benefits than current professional-led psychoeducation in diverse health outcomes of these psychotic patients such as functioning, problem-solving, and recovery. This multi-center randomized controlled trial with repeated measures, 3-arm design is proposed to test and compare the effects between two alternative interventions (PASIM and Psychoeducation Group program) and a usual-care-only group over an 18-month follow-up.

Detailed description

Objectives:

To test the primary hypothesis that the PASIM program can produce significantly greater improvements than psychoeducation and/or usual-care only groups at 1-week, 9-month, and/or 18-month follow-ups on patients' functioning; To test the hypothesis that the PASIM program will produce significantly greater improvements than psychoeducation and usual-care-only over the 18-month follow-ups in patients' psychotic symptoms, problem-solving, illness insight, rehospitalization rates, and/or service satisfaction (secondary outcomes); To explore the strengths, weaknesses and areas for improvements of and satisfaction with the PASIM program, from participants' and peer facilitators' perspectives, using individual semi-structured interviews.

Design: A multi-center randomized controlled trial with repeated measures, 3-arm design will be conducted with both outcome and process evaluation.

Subjects: 186 adults with recent-onset psychosis and randomly assigned into three study groups.

Data collection procedure: After explaining the study and ethical issues to participants, written consent and then baseline measurement will be obtained. During interventions, participants' attendance, workbook completion and attritions will be monitored. At 1-week (Posttest-1), and 9- (Posttest-2) and 18-month (Posttest-3) post-intervention, outcome measurements will be evaluated. In addition, individual semi-structured interviews will be conducted after Posttest-1.

Data analysis: Generalized Estimating Equation test will be used to compare mean-value changes in individual outcomes, and Kaplan-Meier survival-analysis used to analyze the relative risks of re-hospitalizations, between groups over follow-ups. Content analysis will be conducted for qualitative interview data.

Expected results: The PASIM is the first peer-supported self-help for illness management intervention for early-stage psychosis, particularly in Chinese population. It can be a useful and potential cost-saving intervention in community mental healthcare service, providing accessible, self-learned illness self-management training facilitated by peer-support workers (persons recovered from psychosis) in views of limited healthcare resources and mental health professionals in locally and internationally.

Interventions

• Behavioral PASIM program
  The program consists of 5 modules for ROP patients (translated, refined and validated by research team) and 4 group sessions (1.5 hours per session; 8-10 members/group; in-between completion of the 5 modules) facilitated by a peer-support worker over 5 months. The 5 modules include: Module 1-Patient's well-being; Module 2-Getting the best out of support services; Module 3-Acceptance and insight toward psychosis and long-term self-care; Module 4-Dealing with psychosocial effects of the illness- I
• Behavioral Psychoeducation
  The psychoeducation group (5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group. The program consists of 12 two-hour sessions held weekly or biweekly (similar to the PASIM) over 5 months with four key components, including introduction and goal setting; an education workshop on psychosis care and community service; learning effective coping and self-care skills with rehearsals/reviews; and skil
• Behavioral Usual-Care-only
  Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Primary outcome measures

• Patient functioning [Time frame: Baseline]
• Patient functioning [Time frame: Change from baseline to 1-week post-intervention]
• Patient functioning [Time frame: Change from baseline to 9-month follow-up after the intervention]
• Patient functioning [Time frame: Change from baseline to 18-month follow-up after the intervention]

Secondary outcome measures (12)

• Problem-solving ability [Time frame: Baseline]
• Problem-solving ability [Time frame: Change from baseline to 1-week post-intervention]
• Problem-solving ability [Time frame: Change from baseline to the 9-month follow-up after the intervention]
• Problem-solving ability [Time frame: Change from baseline to 18-month follow-up after the intervention]
• Psychotic symptoms [Time frame: Baseline]
• Psychotic symptoms [Time frame: Change from baseline to 1-week post-intervention]
• Psychotic symptoms [Time frame: Change from baseline to 9-month follow-up after the intervention]
• Psychotic symptoms [Time frame: Change from baseline to 18-month follow-up after the intervention]
• Insight into illness/treatment [Time frame: Baseline]
• Insight into illness/treatment [Time frame: Change from baseline to 1-week post-intervention]
• Insight into illness/treatment [Time frame: Change from baseline to 9-month follow-up after the intervention]
• Insight into illness/treatment [Time frame: Change from baseline to 18-month follow-up after the intervention]

Eligibility criteria

Inclusion criteria

• Primarily diagnosed with psychosis (or ROP with <5 years of illness as defined in recent literature), including brief, first-episode and other psychotic disorders according to the criteria of the DSM-5 \[American Psychiatric Association 2013\];
• H.K. Chinese residents, aged 18-64 years;
• Global Assessment of Functioning scores ≥51, indicating mild to moderate symptoms and difficulties in psychosocial/occupational functioning \[American Psychiatric Association 2013\], being mentally stable to comprehend APSI or psychoeducation and outcome measures;
• Able to read and understand Cantonese/ Mandarin.

Exclusion criteria

• Have received or are receiving other psychotherapies;
• Comorbidity with other mental (learning disability, cognitive, or personality disorder) or significant medical disease(s);
• And/or communication, visual or hearing difficulty.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

China · 2 centers

• Integrated Community Centers for Mental Wellness — Hong Kong
• Psychiatric outpatient clinics in one hospital cluster of Hospital Authority — Hong Kong

Publications

• Chien WT, Chong YY, Bressington D, McMaster CW. A randomized controlled trial of an acceptance-based, insight-inducing medication adherence therapy (AIM-AT) for adults with early-stage psychosis. Psychiatry Res. 2024 Sep;339:116046. doi: 10.1016/j.psychres.2024.116046. Epub 2024 Jun 17. PMID 38908265
• Chien WT, Bressington D, Lubman DI, Karatzias T. A Randomised Controlled Trial of a Caregiver-Facilitated Problem-Solving Based Self-Learning Program for Family Carers of People with Early Psychosis. Int J Environ Res Public Health. 2020 Dec 14;17(24):9343. doi: 10.3390/ijerph17249343. PMID 33327452
• Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10. PMID 26193827
• Chien WT, Cheng HY, McMaster TW, Yip ALK, Wong JCL. Effectiveness of a mindfulness-based psychoeducation group programme for early-stage schizophrenia: An 18-month randomised controlled trial. Schizophr Res. 2019 Oct;212:140-149. doi: 10.1016/j.schres.2019.07.053. Epub 2019 Aug 12. PMID 31416744

Identifiers

NCT: NCT07129369 · 14608525

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗