University of Washington
Dror Ben-Zeev
In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.
Psychosis
Mania
Depression
mHealer
Not Applicable
The study involves deployment of an intervention in Ghanian prayer camps where traditional and faith healers provide care for people with mental illness. The intervention has two components: a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called M-Healer that is used by the staff working at the camps. The app is designed to provide them with training on how to deliver some psychosocial interventions, monitor the health and well-being of their patients, and protect human rights at the camps. The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention. Throughout the study, participant data will be collected at baseline, mid-treatment, and post-treatment. Following study completion, the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 360 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa |
| Actual Study Start Date : | June 30, 2023 |
| Estimated Primary Completion Date : | May 31, 2027 |
| Estimated Study Completion Date : | May 31, 2027 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Enhanced Usual Care In the Enhanced Usual Care arm, all healers are invited to participate in an interactive session reviewing ways to reduce inhumane and potentially harmful treatments in practices at their camps. |
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Experimental: M&M Intervention Package M&M is a 8-week long combination of mHealth designed to train healers to deliver basic psychosocial interventions while preserving human rights with pharmacotherapy delivered directly to their patients via visiting nurse. |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University of Ghana
Accra, Ghana, GP4236