About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

PASIM program
Behavioral
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; and Module 5-Dealing with physical/mental health effects of the illness- II. The 4 group sessions will be conducted at the orientation and after reading the 1st, 3rd and 5th module to introduce the program, encourage to complete the module per month, performing value clarifying and acceptance (psychological flexibility) exercises, and clarify and discuss self-care learning and and challenges.
Psychoeducation
Behavioral
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 skills practices and preparing for future life.
Usual-Care-only
Behavioral
Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Treatment groups

186 Participants

are divided into 3 treatment groups

Group A: PASIM groupExperimental treatment 2 interventions

Group B: Psychoeducation groupExperimental treatment 2 interventions

Group C: Usual-care-only groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Patient functioning

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.

Time frame

Baseline

2

Patient functioning

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.

Time frame

Change from baseline to 1-week post-intervention

3

Patient functioning

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.

Time frame

Change from baseline to 9-month follow-up after the intervention

4

Patient functioning

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.

Time frame

Change from baseline to 18-month follow-up after the intervention

Secondary outcomes

1

Problem-solving ability

Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

Time frame

Baseline

2

Problem-solving ability

Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

Time frame

Change from baseline to 1-week post-intervention

3

Problem-solving ability

Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

Time frame

Change from baseline to the 9-month follow-up after the intervention

4

Problem-solving ability

Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

Time frame

Change from baseline to 18-month follow-up after the intervention

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts