An interventional study of mHealer in Psychosis, Mania and Depression, sponsored by University of Washington. Recruiting at 1 site in Ghana. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 360 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Exclusion Criteria:
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.
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.
Behavioral: mHealer
MHealer is a software application installed on smartphones that provides psychosocial treatment support and patient condition tracking.
Psychiatric symptoms
Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale
Time frame: Baseline, 4 weeks, 8 weeks
Depressive symptoms
Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9
Time frame: Baseline, 4 weeks, 8 weeks
Plan to share: Undecided — De-identified data from the study may be shared in future, yet-to-be-known, research. Data may be used to evaluate mechanism of intervention action, documentation of prevalence of psychiatric illnesses in the region, relationships between clinical or demographic variables and treatment outcomes, or use of technology in the region.
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for May 2027, 43 months after the start.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 43 months is above that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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