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

NCT05703711 | Recruiting DMC

• 2 other identifiers: STUDY000155491R01MH127531-01A1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Mania; Depression

Keywords

mHealth; Psychosis; Mania; Depression

Outcome Measures

Primary Outcomes (2)

• Psychiatric symptoms

  Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale

  Baseline, 4 weeks, 8 weeks

• Depressive symptoms

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

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

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

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

Interventions

mHealer BEHAVIORAL

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

M&M Intervention Package

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Speaks Twi or English
• Current inpatient staying at a study prayer camp
• A diagnosis of psychosis, mania, or depression

You may not qualify if:

• Serious physical illness or in need of urgent medical attention

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Ghana

Accra, GP4236, Ghana

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Mania; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Dror Ben-Zeev, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Ben-Zeev, PhD

CONTACT

206-685-9655; dbenzeev@uw.edu

Alexa Beaulieu, MPH

CONTACT

253-261-8661; beaulia@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

GH (1)