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

IF 4.9 2区 医学 Q1 CLINICAL NEUROLOGY
Naveed Ahmed , Gerardo A. Zavala , Faraz Siddiqui , Faiza Aslam , Ada Keding , Shannon Halmkan , Saima Afaq , Hannah Maria Jennings , Ashraful Anas , Sanjit K. Shaha , Kazi Moriom Jahan , Abdul Kuddus , Zara Nisar , Simon M. Walker , Anum Naz , Hira Shakoor , Asima K. Niazi , Rowena Jacobs , Karen Coales , Kishwar Azad , Catherine Hewitt
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引用次数: 0

Abstract

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.
行为激活作为糖尿病和抑郁症患者治疗的随机对照可行性试验:(DiaDeM可行性试验)。
背景:缺乏有效治疗T2DM患者抑郁症的证据,特别是在低收入和中等收入国家(LMICs)。本研究旨在测试文化适应性行为激活(BA)干预(DiaDeM)对两个南亚低收入国家的抑郁症和2型糖尿病患者的可行性和可接受性。方法:于2022年3月至2022年11月进行多国、单独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诊断为抑郁症和2型糖尿病的成年人。同意的个体被随机分配到优化的常规护理或DiaDeM干预中,其中包括由非心理健康促进者在6至12周内提供的6次BA会议。参与者在随机分组后的3个月和6个月进行了随访。评估招募和保留、干预措施实施和数据收集的可行性和可接受性。还进行了混合方法过程评估,以告知主要试验。结果:DiaDeM可行性试验成功招募了128名参与者,随访6个月时保留率为85% %。大多数参与者参与了干预,表现出对行为激活(BA)会话的良好依从性。包括抑郁严重程度和HbA1c水平在内的关键结局的数据完整性在所有时间点都很高(bbb90 %)。过程评估显示了干预的高可接受性,参与者报告了增加的动机和改善的T2DM和抑郁症管理。讨论:良好的招募率和保留率,数据收集的完整性和干预措施的高可接受性表明进行全面试验是可行的。
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来源期刊
Journal of affective disorders
Journal of affective disorders 医学-精神病学
CiteScore
10.90
自引率
6.10%
发文量
1319
审稿时长
9.3 weeks
期刊介绍: The Journal of Affective Disorders publishes papers concerned with affective disorders in the widest sense: depression, mania, mood spectrum, emotions and personality, anxiety and stress. It is interdisciplinary and aims to bring together different approaches for a diverse readership. Top quality papers will be accepted dealing with any aspect of affective disorders, including neuroimaging, cognitive neurosciences, genetics, molecular biology, experimental and clinical neurosciences, pharmacology, neuroimmunoendocrinology, intervention and treatment trials.
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