Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

Not Applicable

Recruiting

• Conditions: Mania; Depression; Psychosis
• Interventions: Behavioral: mHealer

• Registration Number: NCT05703711
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-10-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Aged 18 years or older
• Speaks Twi or English
• Current inpatient staying at a study prayer camp
• A diagnosis of psychosis, mania, or depression

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Exclusion Criteria

• Serious physical illness or in need of urgent medical attention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
M&M Intervention Package	mHealer	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.

Primary Outcome Measures

Name	Time	Method
Psychiatric symptoms	Baseline, 4 weeks, 8 weeks	Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale
Depressive symptoms	Baseline, 4 weeks, 8 weeks	Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9

Trial Locations

Locations (1)

University of Ghana; 🇬🇭 Accra, Ghana