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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05703711
Enrollment
360
Registered
2023-01-30
Start date
2023-10-25
Completion date
2027-05-31
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Mania, Psychosis

Keywords

mHealth, Psychosis, Mania, Depression

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.

Interventions

BEHAVIORALmHealer

MHealer is a software application installed on smartphones that provides psychosocial treatment support and patient condition tracking.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Psychiatric symptomsBaseline, 4 weeks, 8 weeksChange in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale
Depressive symptomsBaseline, 4 weeks, 8 weeksChange in depressive symptoms of participants as measured by the Patient Health Questionnaire-9

Countries

Ghana

Contacts

Primary ContactDror Ben-Zeev, PhD
dbenzeev@uw.edu206-685-9655
Backup ContactAlexa Beaulieu, MPH
beaulia@uw.edu253-261-8661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026