A randomised controlled feasibility trial of Behavioural activation as a treatment for people with diabetes and depression:(DiaDeM feasibility trial)

Background: There is a lack of evidence on effective treatments for depression in people with T2DM, particularly in Low and Middle-Income Countries (LMICs). This study aims to test the feasibility and acceptability of a culturally adapted Behavioural Activation (BA) intervention (DiaDeM) for people with depression and T2DM in two South Asian LMICs. Methods: A multicountry, individually randomised-controlled feasibility trial was conducted from March 2022 to November 2022. We recruited adults from diabetes healthcare facilities in Bangladesh and Pakistan with a diagnosis of depression and T2DM. Consenting individuals were randomised to either optimised usual care or the DiaDeM intervention, which comprised six BA sessions delivered by non-mental health facilitators over six to twelve weeks. Participants were followed up at three and six months post-randomisation. The feasibility and acceptability of recruitment and retention, intervention delivery, and data collection were assessed. A mixed-methods process evaluation was also performed to inform the main trial. Results: The DiaDeM feasibility trial successfully recruited 128 participants, with 85 % retention at six months follow-up. The majority of participants engaged with the intervention, demonstrating good adherence to the Behavioural Activation (BA) sessions. Data completeness for key outcomes, including depression severity and HbA1c levels, was high across all time points (>90 %). The process evaluation showed high acceptability of the intervention, with participants reporting increased motivation and improved management of both T2DM and depression. Discussion: Good recruitment and retention rates, completeness of data collection, and high acceptability of the intervention showed that it would be feasible to undertake a full-scale trial.