Mekdes Demissie, Charlotte Hanlon, Lauren C Ng, Rosie Mayston, Abebaw Fekadu
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引用次数: 0
Abstract
Background: 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.
Method: 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.
Results: 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.
Conclusions: This contextually developed psychological intervention for bipolar disorder has promising feasibility, acceptability, and potential utility. Further studies should evaluate time considerations and effectiveness.
Trial registration: 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 .
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.