Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202482587686 Date of Approval: 28/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peer-led recovery groups for people with schizophrenia in South Africa (PRIZE): a randomized feasibility trial
Official scientific title Peer-led recovery groups for people with schizophrenia in South Africa (PRIZE): a randomized feasibility trial
Brief summary describing the background and objectives of the trial BACKGROUND: There is growing recognition of the potential for peer support approaches in mental health, including for people with schizophrenia. Evidence for the acceptability and feasibility of peer led groups has not been formally assessed in South Africa, and evidence from other low- and middle-income countries is still limited. AIM: To assess the acceptability and feasibility of peer-led recovery groups for people with schizophrenia and their caregivers in South Africa, and to determine key parameters in preparation for a definitive trial (including recruitment and retention rates, feasibility of individual level randomisation, competency of interventionists, and validity of outcome measures).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PRIZE
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Treatment as usual 5 months TAU consists of treatment at the clinic, delivered mainly by psychiatric nurses. A general physician typically provides care at each clinic on an approximately weekly basis, but this varies across clinics. Frequency of attendance is determined by clinical need, but regular appointments are usually monthly. Treatment includes prescription of anti-psychotic medication, and symptom checking and medication psychoeducation. Nurses can refer to the physician within the clinic, if available, for complex medication or clinical needs. Further referral can be made by the psychiatric nurse or physician to inpatient care at Dora Nginza Hospital or Elizabeth Donkin Hospital in emergency situations. 50 Active-Treatment of Control Group
Experimental Group Peer led recovery groups 5 months Recovery groups will be delivered in two phases: an 8-week auxiliary social worker facilitated phase then a 12-week peer led phase. There will be seven groups and each group will comprise ~5-6 service users and ~5-6 caregivers. Sessions will last 2 hours and will be held in community centres local to participants not in the clinics. In the ASW facilitated phase the session topics are: 1. Introduction to group 2. Understanding mental health 3. Building self-esteem 4. Recovery 1: Keeping well. 5. Recovery 2: Preparing for a crisis 6. Recovery 3: Personal goals 7. Managing money and debt 8. Healthy relationships 9. Closure session and transitioning to the peer-led format ASWs will be supervised by a social worker, who is currently employed by PE Mental Health Society and supervises them in their other work. In the peer-led phase we will provide one-page, plain language session outlines for 8 potential peer led sessions topics which peer facilitators may choose to use. These will echo the sessions covered in the ASW-led phase. Peer-led groups will be led by facilitators (one service user and one caregiver) identified from within the recovery group. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Service user eligibility criteria are: (i) clinical diagnosis of any psychotic disorder that is associated with enduring disability, including schizophrenia, schizoaffective disorder or dual diagnosis of schizophrenia and alcohol use disorder (ii) ≥18 years; (iii) speak isiXhosa; (iv) have capacity to give informed consent; and (v) no plans to move out of the area within the next 6 months. Caregiver eligibility criteria are: (i) primary caregiver for a participating service user; (ii) ≥18 years; (iii) speak isiXhosa; and (iv) no plans to move out of the area within the next 6 months. There are no specific inclusion or exclusion criteria. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/08/2021 South Africa MRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive, Parowvallei, 7505, Cape Town Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/09/2021 University of Nottingham Faculty of Medicine and Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E41, Medical School, Queens Medical Centre Campus, Nottingham University Hospitals Nottingham NG7 2UH United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recovery Assessment Scale Domains and Stages Baseline, 2 months, 5 months
Secondary Outcome Self-reported 12 item WHO Disability Assessment Schedule Baseline, 2 months, 5 months
Secondary Outcome Proxy reported 12-item WHO Disability Assessment Schedule Baseline, 2 months, 5 months
Secondary Outcome Camberwell Assessment of Needs Short Assessment Scale Baseline, 2 months, 5 months
Secondary Outcome Internalised Stigma of Mental Illness Scale Baseline, 2 months, 5 months
Secondary Outcome Alcohol Use Disorders Identification Test - Consumption AUDIT-C Baseline, 2 months, 5 months
Secondary Outcome INSPIRE Support for recovery Baseline, 2 months, 5 months
Secondary Outcome Involvement Evaluation Questionnaire- Caregiving consequences section Baseline, 2 months, 5 months
Secondary Outcome Medication adherence 4 point ordinal scale Baseline, 2 months, 5 months
Secondary Outcome Health service use- number, duration and reason for inpatient admissions; and number of consultations with different types of healthcare worker in the last 2 months Baseline, 2 months, 5 months
Secondary Outcome Relapse- inpatient admission for mental health OR police contact for mental health Baseline, 2 months, 5 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South Africa MRC Tygerberg 7505 Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
UK South Africa Newton Fund UK Medical Research Council South Africa Medical Research Council UK Research and Innovation, Polaris House Swindon SN2 1FL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie van Zijl Drive, Parow Valley, Tygerberg, 7505 Cape Town South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Julie Repper ImROC Implementing Recovery through Organisational Change Learning and Development Department, Nottinghamshire Healthcare NHS Foundation Trust, Duncan Macmillan House, Porchester Road, Mapperley, Nottingham NG3 6AA United Kingdom
Mike Slade Faculty of Medicine and Health Sciences, Room D23 Institute of Mental Health, Innovation Park, Triumph Road Nottingham NG7 2TU United Kingdom
Bharti Patel 267 Long Ave, Ferndale, Randburg, 2194 Johannesburg South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laura Asher laura.asher@nottingham.ac.uk 00441158231368 Room B117 Clinical Sciences Building, Nottingham City Hospital
City Postal code Country Position/Affiliation
Nottingham NG5 1PB United Kingdom PI
Role Name Email Phone Street address
Public Enquiries Carrie Brooke Sumner carrie.brooke-sumner@mrc.ac.za +27219380406 South African Medical Research Council, Alcohol, Tobacco and Other Drug Research Unit, Francie van Zijl Drive, Parow Valley, Tygerberg, 7505
City Postal code Country Position/Affiliation
Cape Town South Africa PI
Role Name Email Phone Street address
Scientific Enquiries Laura Asher laura.asher@nottingham.ac.uk +441158231368 Room B117 Clinical Sciences Building, Nottingham City Hospital
City Postal code Country Position/Affiliation
Nottingham NG5 1PB United Kingdom Clinical Associate Professor of Public Health University of Nottingham
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will make available all of the individual participant data collected during the trial, after deidentification Study Protocol Data will be available 6 months after publication of the main trial results and ending 3 years after publication. Data will be made available to researchers who provide a methodologically sound proposal for any purpose. Proposals should be directed to laura.asher@nottingham.ac.uk. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information