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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 186
- Locations
- 2
- Primary Endpoint
- Patient functioning
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
Center / Clinical staff
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
PASIM group
Participants in the PASIM program will study and complete the self-learning manual (printed and online versions available) with 5 modules for ROP patients (translated, refined and validated by research team) and participate in 4 group sessions facilitated by a peer-support worker over 5 months.
Intervention: PASIM program (Behavioral)
PASIM group
Participants in the PASIM program will study and complete the self-learning manual (printed and online versions available) with 5 modules for ROP patients (translated, refined and validated by research team) and participate in 4 group sessions facilitated by a peer-support worker over 5 months.
Intervention: Usual-Care-only (Behavioral)
Psychoeducation group
The psychoeducation group (12 two-hour sessions, 5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group.
Intervention: Psychoeducation (Behavioral)
Psychoeducation group
The psychoeducation group (12 two-hour sessions, 5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group.
Intervention: Usual-Care-only (Behavioral)
Usual-care-only group
This control group (and 2 intervention groups) will receive usual community mental healthcare services provided by POPCs and ICCMWs. Patients in ICCMWs and POPCs may receive services in commons, including occupational/living skills training, education on psychosis care, recreational services, and individual and/or family counseling and referrals to social and health care services as needed. The control group will also receive an information booklet about illness self-care to minimize the Hawthorne effect from the PASIM manual reading.
Intervention: Usual-Care-only (Behavioral)
Outcomes
Primary Outcomes
Patient functioning
Time Frame: Change from baseline to 18-month follow-up after the intervention
The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.
Patient functioning
Time Frame: Baseline
The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.
Patient functioning
Time Frame: Change from baseline to 1-week post-intervention
The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.
Patient functioning
Time Frame: Change from baseline to 9-month follow-up after the intervention
The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.
Secondary Outcomes
- Problem-solving ability(Change from baseline to 18-month follow-up after the intervention)
- Psychotic symptoms(Change from baseline to 18-month follow-up after the intervention)
- Insight into illness/treatment(Change from baseline to 18-month follow-up after the intervention)
- Rehospitalization rate(At 18-month follow-up after the intervention)
- Service satisfaction(Change from baseline to the 18-month follow-up after the intervention)
- Problem-solving ability(Baseline)
- Problem-solving ability(Change from baseline to 1-week post-intervention)
- Problem-solving ability(Change from baseline to the 9-month follow-up after the intervention)
- Psychotic symptoms(Baseline)
- Psychotic symptoms(Change from baseline to 1-week post-intervention)
- Psychotic symptoms(Change from baseline to 9-month follow-up after the intervention)
- Insight into illness/treatment(Baseline)
- Insight into illness/treatment(Change from baseline to 1-week post-intervention)
- Insight into illness/treatment(Change from baseline to 9-month follow-up after the intervention)
- Rehospitalization rate(Baseline)
- Rehospitalization rate(At 1-week post-intervention)
- Rehospitalization rate(At 9-month follow-up after the intervention)
- Service satisfaction(Baseline)
- Service satisfaction(Change from baseline to 1-week post-intervention)
- Service satisfaction(Change from baseline to 9- month follow-up after the intervention)
Investigators
Prof. Wai Tong CHIEN
Professor
Chinese University of Hong Kong