Demissie Mekdes, Hanlon Charlotte, Ng Lauren C, Mayston Rosie, Fekadu Abebaw
Department of Psychiatry, College of Health and Medical Sciences, Haramaya University, Dire Dawa, Ethiopia.
Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), Addis Ababa University, Addis Ababa, Ethiopia.
Pilot Feasibility Stud. 2025 Jul 17;11(1):99. doi: 10.1186/s40814-025-01683-9.
There is a very large unmet need for appropriate psychological interventions for bipolar disorder (BD) for use in low- and middle-income countries. We developed a psychological intervention for BD in a primary health care (PHC) setting in Ethiopia using the Medical Research Council's framework for the Development and Evaluation of Complex Interventions. The aim of this study is to investigate the feasibility, acceptability, and fidelity of this newly developed psychological intervention for BD in a PHC setting in south-central Ethiopia.
A total of 12 euthymic people with bipolar disorder and five caregivers participated in five 20-min weekly sessions of the psychological intervention. We conducted a mixed-method evaluation, including in-depth qualitative interviews, fidelity ratings of a random selection of 25% of the audio recorded intervention sessions, and self-reported change in symptom severity. We used thematic analysis for qualitative data and descriptive analysis for quantitative data.
Except for one caregiver, all participants completed all five sessions. Intervention providers and recipients expressed satisfaction with the intervention. Intervention providers reported that the intervention can be feasibly delivered in the PHC setting, although 20 min was considered insufficient. While participants acknowledged the importance of involving caregivers in the intervention, they raised privacy concerns. Intervention providers' adherence to the manual was moderate. Preliminary findings indicate a reduction in depressive symptoms post-intervention and improvement in providers' perceived knowledge and skills.
This contextually developed psychological intervention for bipolar disorder has promising feasibility, acceptability, and potential utility. Further studies should evaluate time considerations and effectiveness.
The trial was registered on 16 August 2024, retrospectively on the Pan African Clinical Trial Registry database [PACTR202408896160144], https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=31727 .
在低收入和中等收入国家,双相情感障碍(BD)亟需合适的心理干预措施,但目前这一需求远未得到满足。我们利用医学研究理事会关于复杂干预措施开发与评估的框架,在埃塞俄比亚的初级卫生保健(PHC)环境中开发了一种针对双相情感障碍的心理干预措施。本研究的目的是调查这种新开发的针对双相情感障碍的心理干预措施在埃塞俄比亚中南部初级卫生保健环境中的可行性、可接受性和保真度。
共有12名双相情感障碍缓解期患者和5名护理人员参加了为期五周、每周一次、每次20分钟的心理干预课程。我们进行了混合方法评估,包括深入的定性访谈、对随机抽取的25%的音频记录干预课程进行保真度评级,以及自我报告的症状严重程度变化。我们对定性数据采用主题分析,对定量数据采用描述性分析。
除一名护理人员外,所有参与者都完成了全部五节课程。干预提供者和接受者对干预表示满意。干预提供者报告称,尽管认为20分钟时间不足,但该干预措施在初级卫生保健环境中可以切实实施。虽然参与者承认护理人员参与干预的重要性,但他们也提出了隐私方面的担忧。干预提供者对手册的依从性中等。初步研究结果表明,干预后抑郁症状有所减轻,提供者感知到的知识和技能有所提高。
这种根据具体情况开发的双相情感障碍心理干预措施具有良好的可行性、可接受性和潜在效用。进一步的研究应评估时间因素和有效性。
该试验于2024年8月16日进行了注册,追溯登记在泛非临床试验注册数据库[PACTR202408896160144],https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=31727 。