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

July 23, 2024 updated by: Dror Ben-Zeev, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dror Ben-Zeev, PhD
  • Phone Number: 206-685-9655
  • Email: dbenzeev@uw.edu

Study Contact Backup

  • Name: Alexa Beaulieu, MPH
  • Phone Number: 253-261-8661
  • Email: beaulia@uw.edu

Study Locations

  • Ghana
      • Accra, Ghana, GP4236
        • Recruiting
        • University of Ghana
        • Contact:
          • Angela Ofori-Atta, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Enhanced Usual Care
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.
Experimental: M&M Intervention Package
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress
Time Frame: Baseline, 4 weeks, 8 weeks
Change in psychological distress of participants as measured by the Talbieh Brief Distress Inventory
Baseline, 4 weeks, 8 weeks
Quality of Life
Time Frame: Baseline, 4 weeks, 8 weeks
Change in perceived quality of life as measured by the Lehman Quality of Life Interview for Chronically Mentally Ill
Baseline, 4 weeks, 8 weeks
Shame
Time Frame: Baseline, 4 weeks, 8 weeks
Change is perceived shame of participants as measured by the Other As Shamer Scale
Baseline, 4 weeks, 8 weeks
Human rights violations
Time Frame: Baseline, 4 weeks, 8 weeks
Change in human rights violations of participants as measured by direct observation and first-person reports
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Dror Ben-Zeev, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00015549
  • 1R01MH127531-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe