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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05703711
• Other study ID #: STUDY00015549
• Secondary ID: 1R01MH127531-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: August 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Mania
• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychiatric symptoms	Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale	Baseline, 4 weeks, 8 weeks
Primary	Depressive symptoms	Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9	Baseline, 4 weeks, 8 weeks