Ahmed Naveed, Zavala Gerardo A, Siddiqui Faraz, Aslam Faiza, Keding Ada, Halmkan Shannon, Afaq Saima, Jennings Hannah Maria, Anas Ashraful, Shaha Sanjit K, Jahan Kazi Moriom, Kuddus Abdul, Nisar Zara, Walker Simon M, Naz Anum, Shakoor Hira, Niazi Asima K, Jacobs Rowena, Coales Karen, Azad Kishwar, Fottrell Edward, Haq Zia Ul, Ekers David, Siddiqi Najma, Hewitt Catherine
Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Bangladesh; BIRDEM General Hospital, Bangladesh.
Department of Health Sciences, University of York, United Kingdom.
J Affect Disord. 2025 Mar 1;372:333-346. doi: 10.1016/j.jad.2024.11.079. Epub 2024 Dec 6.
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.
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.
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.
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.
对于2型糖尿病患者的抑郁症，尤其是在低收入和中等收入国家（LMICs），缺乏有效治疗的证据。本研究旨在测试一种针对南亚两个低收入和中等收入国家中患有抑郁症和2型糖尿病患者的文化适应性行为激活（BA）干预措施（DiaDeM）的可行性和可接受性。
2022年3月至2022年11月进行了一项多国家、个体随机对照可行性试验。我们从孟加拉国和巴基斯坦的糖尿病医疗机构招募了被诊断为抑郁症和2型糖尿病的成年人。同意参与的个体被随机分配到优化的常规护理组或DiaDeM干预组，后者包括由非心理健康促进者在六至十二周内进行的六次BA课程。在随机分组后的三个月和六个月对参与者进行随访。评估了招募和保留、干预实施以及数据收集的可行性和可接受性。还进行了混合方法的过程评估，以为主要试验提供信息。
DiaDeM可行性试验成功招募了128名参与者，在六个月随访时的保留率为85%。大多数参与者参与了干预，对行为激活（BA）课程表现出良好的依从性。在所有时间点，包括抑郁严重程度和糖化血红蛋白水平在内的关键结局的数据完整性都很高（超过9０%）。过程评估显示该干预具有很高的可接受性，参与者报告其动机增强，2型糖尿病和抑郁症的管理得到改善。
良好的招募和保留率、数据收集的完整性以及干预的高可接受性表明进行全面试验是可行的。
