Evaluation of a Peer-Led Self-Management Programme (PLSMP) for people with schizophrenia
| ISRCTN | ISRCTN08387324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08387324 |
| Protocol serial number | CIRG12nov043 |
| Sponsor | National University of Singapore (Singapore) |
| Funder | National Medical Research Council (Singapore) - Clinician-Scientist Individual Investigators Grant (CIRG12nov043) |
- Submission date
- 12/09/2013
- Registration date
- 17/09/2013
- Last edited
- 18/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Self-management programmes have been developed to empower patients with severe mental illness in achieving recovery. Previous research suggested that Peer-Led Self-Management programmes (PLSMP) have been effective in patient recovery. However, the evidence is uncertain. This study aims to find out how well the PLSMP works for people with schizophrenia, in reducing symptom severity, hospital readmission and psychiatric consultation, and in improving mental ability, empowerment, functioning level, medication adherence, recovery, quality of life, and social support. This study also aims to find out about the trainers and participants experience with the PLSMP.
Who can participate?
Clients, aged 21 to 65, coming to the participating centres, who are diagnosed with schizophrenia, in a stable condition and who have not been admitted to hospital due to relapse of schizophrenia symptoms in the past 6 months, can participate in this study.
What does the study involve?
The participants will be randomly assigned to a control group or an intervention group. The control group will receive standard programmes provided by the centre. The intervention group will receive the standard rehabilitation programmes plus a 6-week peer-led self-management programme (PLSMP), which will be provided by peer trainers, who are former patients. The participants will need to meet the researchers for four assessments in the course of the study. Each assessment consists of a same set of self-rating questionnaires on various parameters. The participants will also be invited to an optional individual interview to express their opinion on the programme 12 months after completion. This will take about 30 minutes.
What are the possible benefits and risks of participating?
This study does not provide a direct benefit to the participants. However, the findings obtained from the study may help to improve the management of the condition and treatment in future. There is no foreseeable possible discomfort and no more than minimum risk to the participants. However, if at any point of time, they dont feel comfortable with the study procedures and assessments, they can stop participating in this study.
Where is the study run from?
This study will be conducted in three community psychiatric rehabilitation centres in Singapore: Simei Care Centre (SCC), Hougang Care Centre (HCC), Community Rehabilitation and Support Services (CRSS); and three psychiatric day centres in Singapore: OcTAVE day centres of Institute of Mental Health.
When is study starting and how long is it expected to run for?
The study will start in October 2013 and is expected to run until September 2016.
Who is funding the study?
This study is funded by the National Medical Research Council, Singapore.
Who is the main contact?
Professor Sally Chan
nurcwcs@nus.edu.sg
Contact information
Scientific
Alice Lee Centre for Nursing Studies
Block MD 11
National University of Singapore
10 Medical Drive
Singapore
117597
Singapore
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Stratified randomized controlled two-group pretest and repeated posttest between subjects design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of a Peer-led Self-Management Programme (PLSMP) for people with schizophrenia: a randomized controlled trial |
| Study acronym | PLSMP |
| Study objectives | Participants who complete the PLSMP will report significantly lower psychotic symptoms, higher scores on cognition level, empowerment, functioning level, medication adherence attitude, perceived recovery, quality of life, perceived social support and fewer number of readmission and psychiatric consultation. |
| Ethics approval(s) | Institution Review Board (IRB) of National University of Singapore, Singapore; Date: 12 September 2013; Reference number: 11-257 |
| Health condition(s) or problem(s) studied | Psychiatry/schizophrenia/rehabilitation |
| Intervention | Standard Rehabilitation Programme Both control and experimental group will receive the standard rehabilitation programme provided at the centres which is conducted by professionals. It consists of psychoeducation, social skills training, employment skill training, life skills training, and academic educational & information technology training. Intervention Protocol The experimental group, on top of the standard rehabilitation programme, will receive the PLSMP. The PLSMP was developed with reference from current PLSMP programmes conducting at the in-patient setting in Singapore, the US, literature and previous studies. The four theoretical principles (experiential knowledge, social support, social learning, and empowerment) are the foundation for building the programme. The content of the PLSMP have been reviewed by an expert panel which consisted of two psychiatric nurse educators, one psychiatrist, one psychologist, two social workers and two expert patients. Based on the existing evidence on the length of effective PLSMPs, the PLSMP in the proposed study will have six weekly sessions (two hours each). The group size for the programme is about five to ten participants. The PLSMP is designed to be an interactive educational programme. Each session will consist of two parts. In the first hour the peer trainers will deliver the self-management knowledge and skills. Training workbook and handouts will be distributed to facilitate learning. In the second hour the peer trainers will share the experiential knowledge in their own successful experiences. The participants will subsequently be encouraged to discuss on their opinions as well as their developed ways of coping. Group therapy ground rules will be laid prior to commencement of each session. Peer trainers are expert patients who have been selected and recommended by the study centres health care professionals including centre in-charge (a collaborator of the study), clinician, psychologist occupational therapist and social worker. Expert patients are defined as people with schizophrenia who are currently managing their condition and treatment with confidence and in collaboration with psychiatric healthcare professionals. They should also possess effectively communication skills and English language proficiency of secondary school or above. Nine expert patients have been trained by the principal investigator (PI) and two chief investigators (CI) for this study. They have been trained on the use of standard materials for training the participants, presentation skills and group facilitation skills. Training guide was provided to them for learning and reference. They have been assessed by the research team through a simulated group session before they are appointed qualified peer trainer to ensure they have the required knowledge and skills. All trained peer trainers passed the assessment. Each PLSMP session will have one peer trainer presented. One CI is presented at each session as observer to ensure the programme is delivered in standard way as described by the programme manual and to provide feedback to the peer trainers. Besides assessing peer trainers performance at each session, the CI will observe the group interaction, intervene and de-escalate disruptive or stressful situation, and debrief peer trainers after each session. |
| Intervention type | Other |
| Primary outcome measure(s) |
Compared to the control group, participants who complete the peer-led self-management program will report significantly lower psychotic symptom scores at 12 months follow up. Outcome will be assessed at baseline, immediate after the intervention (posttest 1), six months (posttest 2) and 12 months (posttest3) after the intervention. Individual interviews will be conducted for trainers and participants 12 months after the intervention. |
| Key secondary outcome measure(s) |
Outcome will be assessed at baseline, immediate after the intervention (posttest 1), six months (posttest 2) and 12 months (posttest3) after the intervention. Individual interviews will be conducted for trainers and participants 12 months after the intervention. |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 242 |
| Key inclusion criteria | This study aims to sample the whole population at the six centres (Simei Care Centre (SCC), Hougang Care Centre (HCC), Community Rehabilitation Support & Service (CRSS) and three Occupational Therapy: Activities, Vocation and Empowerment (OcTAVE) day centres) who meets the sample inclusion criteria during one-year recruitment period. This study will include participants who are: 1. Diagnosed with schizophrenia or schizoaffective disorders by a clinical psychiatrist according to DSM-IV or ICD-10 2. In a stable condition, not in acute mental health crisis or psychotic episode, and not been admitted to hospital due to relapse of schizophrenia symptom in the past 6 months, and no change in antipsychotic dosage in the past 6 months 3. Global Assessment of Functioning score more than 50 4. English speaking 5. 21-65 years old |
| Key exclusion criteria | Potential participants will be excluded if they have: 1. Non-related diagnosis, or having co-morbidity of personality disorders or mental retardation 2. Exposed to other PLSMP previously 3. Incompetent to sign informed consent as assessed by psychiatrist In the event that participants are readmitted into a psychiatric hospital during the intervention period, their participation in the study will cease. If participants are readmitted to psychiatric hospital during the 12-month follow up period and be discharged before the 12-month follow up assessment, they will need re-assessment by their attending psychiatrist using Global Assessment of Functioning (GAF) to determine their competency in continuing with this study (GAF score of 50 and above). If participants are readmitted at 12-month assessment time, their participation will cease. |
| Date of first enrolment | 01/10/2013 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Singapore
Study participating centre
117597
Singapore
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |