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

Sponsor
University of Washington (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05703711
Collaborator
National Institute of Mental Health (NIMH) (NIH)
360
2
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mHealer
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Psychiatric symptoms [Baseline, 4 weeks, 8 weeks]

    Change in psychiatric symptoms of study participants

  2. Depressive symptoms [Baseline, 4 weeks, 8 weeks]

    Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9

Secondary Outcome Measures

  1. Psychological distress [Baseline, 4 weeks, 8 weeks]

    Change in psychological distress of participants as measured by the Talbieh Brief Distress Inventory

  2. Quality of Life [Baseline, 4 weeks, 8 weeks]

    Change in perceived quality of life as measured by the Lehman Quality of Life Interview for Chronically Mentally Ill

  3. Shame [Baseline, 4 weeks, 8 weeks]

    Change is perceived shame of participants as measured by the Other As Shamer Scale

  4. Human rights violations [Baseline, 4 weeks, 8 weeks]

    Change in human rights violations of participants as measured by direct observation and first-person reports

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Washington
  • National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dror Ben-Zeev, Professor: Psychiatry & Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier:
NCT05703711
Other Study ID Numbers:
  • STUDY00015549
  • 1R01MH127531-01A1
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dror Ben-Zeev, Professor: Psychiatry & Behavioral Sciences, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023