A randomised controlled trial of a faith-based culturally adapted intervention for depression in young Muslim women (IM-Adapted): a multi-site feasibility trial protocol.
Megan Smith, Andy Jones, Pashtana Zormati, Louca-Mai Brady, Allan Clark, Atiya Kamal, Farzana Karawalli, Safiya Khan, Silvana E Mengoni, Ghazala Mir, David Turner, Salman Waqar, David Wellsted, Daksha Trivedi
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Abstract
Background: Growing evidence suggests that mental health issues heavily impact Muslims, the largest, fastest growing minority religious group in the UK. High prevalence of anxiety and depression has been reported in young women aged 18 to 30 largely from Bangladeshi and Pakistani Muslim communities in Britain. Evidence suggests that incorporating religious and culturally adapted interventions may improve their effectiveness for Muslim populations, but their feasibility for young women in UK contexts is uncertain. This study aims to test whether a randomised controlled trial (RCT) of a faith-based intervention for young Muslim women living with depression is feasible.
Methods: This study is a two-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be young Muslim women aged 18 to 24 years experiencing mild to moderate low mood or depression in Birmingham and London. The intervention will be delivered by trained therapists, supported by mental health support workers, once a week for 6 weeks. The two arms will be the IM-Adapted faith-based intervention and the standard NHS psychoeducation support group control with a proposed sample size of 30 per arm. Outcomes are referral, recruitment and retention rates, session attendance, adherence and acceptability of intervention, data collection, and adverse events, measured at baseline, 3 and 6 months.
Discussion: The findings will provide early indication as to whether tailored mental health interventions may increase accessibility and effectiveness of support in underserved communities, addressing barriers linked to social and cultural factors. This will guide health services on the incorporation of cultural and religious adaptations in their programmes to better engage minority groups and improve mental health outcomes.
Trial registration: ISRCTN, https://www.isrctn.com/ISRCTN17842222 , registered 17th April 2024.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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