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

University of Washington

Status: Enrolling

Conditions: Psychosis; Depression; Mania

Treatments: Behavioral: mHealer

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05703711

1R01MH127531-01A1 (U.S. NIH Grant/Contract)

STUDY00015549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Serious physical illness or in need of urgent medical attention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Enhanced Usual Care

No Intervention group

Description:

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 Intervention Package

Experimental group

Description:

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.

Treatment:

Behavioral: mHealer