Efficacy and cost-effectiveness of a culturally embedded, participatory music-making intervention (CHIME) to improve the mental health of pregnant women in The Gambia: a cluster randomised controlled trial

Effectiveness of a cluster-randomised controlled trial of a culturally-embedded group music-making intervention (CHIME) to improve the mental health of pregnant women attending antenatal clinics in The Gambia, compared with usual care (waitlist control): a full cluster randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16039584

Enrollment

600

Registered

2026-05-01

Start date

2026-04-16

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptoms of common mental disorders (CMDs) in pregnancy Mental and Behavioural Disorders

Interventions

Intervention arm: Pregnant women in intervention clusters (n = 12) receive the CHIME intervention in addition to usual antenatal care. The CHIME intervention involves groups of up to 15 pregnant women

Eligibility

Sex/Gender

Female

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Currently pregnant (12–27 weeks gestation) at time of recruitment 2. Aged 16 years or older 3. Speaks Mandinka 4. Attending an eligible antenatal clinic in Western Region 1, Western Region 2, or Upper River Region, The Gambia

Exclusion criteria

Exclusion criteria: 1. Currently in severe crisis posing a risk to one's own or others' wellbeing 2. Experiencing current symptoms of psychosis Note: Participants meeting exclusion criteria will be referred to the community mental health team for appropriate care.

Countries

Gambia

Contacts

Public ContactKatie-Rose Sanfilippo

katie-rose.sanfilippo@city.ac.uk+44 (0)20 7040 4032

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026