Feasibility testing a community music programme to improve maternal mental health among pregnant women in Khayelitsha, South Africa
| ISRCTN | ISRCTN25574145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25574145 |
| Sponsors | Stellenbosch University, University of Roehampton |
| Funder | National Institute for Health and Care Research |
- Submission date
- 20/07/2026
- Registration date
- 22/07/2026
- Last edited
- 21/07/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Poor maternal mental health during pregnancy is common in South Africa and can negatively affect both mothers and their babies. Many women experience stress, anxiety, depression, and social isolation during the perinatal period, while access to mental health services remains limited.
The Community Health Intervention through Musical Engagement (CHIME) programme is a culturally grounded group intervention that uses participatory music and singing to support maternal mental health and wellbeing. Previous work in The Gambia found that the intervention was acceptable and showed promising effects on reducing psychological distress.
This study aims to adapt CHIME for use in Khayelitsha, South Africa, and to assess whether it is feasible and acceptable to conduct a larger effectiveness trial.
Who can participate?
Pregnant women aged 16 years or older who are between 16 and 24 weeks pregnant, live in the selected study communities in Khayelitsha, and speak isiXhosa.
What does the study involve?
Participants will be recruited from Nolungile Clinic as well as community networks such as door-to-door, snowball sampling, and NGOs in Khayelitsha. Participants will be randomly assigned either to receive the CHIME intervention immediately or to receive usual care and later receive a shortened version of the programme.
Women participating in CHIME will attend six group sessions involving participatory singing, music activities, and discussions related to emotional wellbeing, coping, resilience, and social support during pregnancy.
Participants will complete interviews and questionnaires at the start of the study, after the intervention, and 6 months later. Some participants and facilitators will also take part in focus groups or interviews about their experiences of the programme.
What are the possible benefits and risks of participating?
Possible benefits include improved emotional wellbeing, increased social support, reduced isolation, and learning coping strategies during pregnancy.
Possible risks include emotional discomfort when discussing personal experiences. Participants who require additional support will be referred to appropriate mental health services.
Where is the study run from?
The study is coordinated by Stellenbosch University and will take place in Khayelitsha, Cape Town (South Africa)
When is the study starting and how long is it expected to run for?
July 2026 to September 2027
Who is funding the study?
The study is funded through the NIHR Global Health Research Group in Community Health Intervention through Musical Engagement for Maternal Mental Health (CHIME)
Who is the main contact?
Prof. Sarah Skeen, skeen@sun.ac.za
Contact information
Principal investigator
Office 6023, 6th Floor, Clinical Building, Francie van Zijl Drive
Department of Global Health, Faculty of Medicine and Health
Sciences, Stellenbosch University
Cape Town
7505
South Africa
 ORCID ID |
0000-0002-7464-2861 |
|---|---|
| Phone | +27 (0)21 938 9758 |
| skeen@sun.ac.za |
Public, Scientific
Office 6023, 6th Floor, Clinical Building, Francie van Zijl Drive
Department of Global Health, Faculty of Medicine and Health
Sciences, Stellenbosch University
Cape Town
7505
South Africa
| ORCID ID |
0000-0001-7947-3043 |
|---|---|
| Phone | +27 (0)21 938 9758 |
| dutoits@sun.ac.za |
Principal investigator
School of Psychology, University of Roehampton
London
SW15 4JD
United Kingdom
| ORCID ID |
0000-0002-6221-6064 |
|---|---|
| Phone | +44 (0)20 8392 3100 |
| Lauren.Stewart@roehampton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research, Prevention |
| Scientific title | An individual feasibility randomised controlled trial of the Community Health Intervention through Musical Engagement (CHIME) programme to improve maternal mental health among pregnant women in Khayelitsha, South Africa |
| Study acronym | CHIME-SA |
| Study objectives | 1. To assess the feasibility and acceptability of the CHIME intervention and trial procedures among perinatal women and community facilitators 2. To identify barriers and facilitators to implementation. 3. To inform improved design and delivery of the intervention for a future definitive trial. 4. To identify delivery costs and pilot methods for assessing cost-effectiveness 5. To assess whether the outcome and covariate measures are understandable and acceptable 6. To estimate parameters required for a definitive trial, including sample size, and potential effect sizes 7. To determine whether progression to a full-scale effectiveness trial is warranted based on prespecified criteria. GREEN (Go): Progression to a definitive trial without major modifications: the CHIME intervention and trial procedures are feasible and acceptable, with high acceptability and feasibility among participating perinatal women and community facilitators; recruitment reaching ≥75% of the target sample within the planned recruitment period; retention at the post-intervention assessment of ≥75%; randomisation procedures acceptable to ≥75% of eligible participants; and evidence of adequate intervention fidelity (≥75% of intervention sessions delivered as intended). AMBER (Amend): Progression following refinement: moderate acceptability and feasibility among participants and facilitators, with barriers identified that are potentially addressable; recruitment reaching 50–75% of the target sample; post-intervention retention of 50–75%; randomisation procedures acceptable to 50–75% of eligible participants; and/or moderate intervention fidelity (50-75% of intervention sessions delivered as intended), where improvements may be achievable through adaptations to training, supervision, or delivery procedures. RED (Further development required): Progression to a definitive trial will not be recommended if the overall findings indicate substantial challenges that cannot reasonably be addressed through further development or refinement of the trial and/or intervention. This may include: low acceptability or feasibility among participants and/or facilitators; recruitment substantially below target (<50%); low post-intervention retention (<50%); limited acceptability of randomisation procedures (<50%); and/or inadequate intervention fidelity across sessions (less than 50% of intervention sessions delivered as intended). Progression decisions will be informed by the overall pattern of findings from the feasibility trial, including quantitative indicators and qualitative insights from participants, community facilitators, and the process evaluation. No single criterion will be used in isolation to determine progression. Instead, criteria will be considered collectively to assess whether the intervention and trial procedures can be optimised for a future definitive effectiveness trial. |
| Ethics approval(s) |
1. Approved 11/04/2025, Health Research Ethics Committee 1 (Research Development and Support Division, PO Box 19063, Tygerberg, Cape Town, 7505, South Africa; +27 (0)21 938 9075; siti@sun.ac.za), ref: N24/11/148 2. Approved 01/04/2025, University of Roehampton Research Integrity and Ethics Committee (Research Services and Ethics Officer Research Office/Grove House University of Roehampton, London, SW15 5SL, United Kingdom, London, SW15 5SL, United Kingdom; +44 (0)20 8392 5785; ethics@roehampton.ac.uk), ref: PSYC 24-505 |
| Health condition(s) or problem(s) studied | Perinatal mental health difficulties including symptoms of depression, anxiety, psychological distress, and reduced wellbeing |
| Intervention | This study is a feasibility individual randomised controlled trial evaluating an adapted version of the Community Health Intervention through Musical Engagement (CHIME) programme in Khayelitsha, South Africa. Participants will be recruited from selected clinics and from the surrounding community, using door-to-door recruitment and snowball sampling. Participants will be randomly assigned in a 1:1 ratio to one of two groups: an intervention arm, which will receive the CHIME programme immediately, or a waitlist control arm, which will receive usual care and later be offered a shortened version of the programme. Randomisation will be overseen by an external statistician using a web-based randomisation programme. Participants in the intervention arm will receive the CHIME intervention. CHIME uses local musical traditions and participatory singing as a culturally resonant, non-stigmatising entry point for engaging with mental health during pregnancy. Group singing is intended to lift mood and enhance social connection to promote psychological resilience, social support, wellbeing, and coping. The intervention was adapted from an intervention developed in The Gambia in partnership with pregnant women and community members in Khayelitsha, Cape Town, and is designed to complement, not replace, routine antenatal care. Facilitators use a structured facilitator handbook comprising a menu of topic modules, each linked to one of seven co-developed songs in isiXhosa, covering social support, emotional wellbeing, anxiety, self-care, stress and rest, intimate relationships, mother–infant bonding, nutrition and antenatal care engagement, and birth and postnatal planning. Materials include a check-in-to-module selection guide, weekly health messages, and lullaby-creation activities.The programme is delivered through six weekly group sessions lasting one hour, by two trained community health workers who co-facilitate each group. Participants in the control arm will receive care as usual during the study period and will receive a waitlist truncated version of the intervention after completion of follow-up assessments |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/09/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Pregnant women between 16–24 weeks gestation 2. Aged 16 years or older 3. Residing within the selected study areas in Khayelitsha, South Africa 4. Able to communicate in isiXhosa 5. Willing and able to provide informed consent (or assent with caregiver consent for participants under 18 years) |
| Key exclusion criteria | 1. Current severe mental health crisis posing risk to self or others 2. Current symptoms of psychosis |
| Date of first enrolment | 13/07/2026 |
| Date of final enrolment | 30/10/2026 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Department of Global Health, Faculty of Medicine and Health
Sciences, Stellenbosch University
Cape Town
7505
South Africa
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | Data generated through the project will be made available after a 2-year embargo period, upon reasonable request and subject to appropriate governance criteria, including ethical approval, data protection requirements, and intended use. Request should be made to Prof. Sarah Skeen (skeen@sun.ac.za). |
Editorial Notes
21/07/2026: Study's existence confirmed by the Stellenbosch University Health Research Ethics Committee.
