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

NCT ID: NCT05703711

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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Psychosis Mania Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

mHealer

Intervention Type BEHAVIORAL

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

Interventions

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mHealer

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Dror Ben-Zeev

Professor: Psychiatry & Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dror Ben-Zeev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Ghana

Accra, , Ghana

Site Status RECRUITING

Countries

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Ghana

Central Contacts

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Dror Ben-Zeev, PhD

Role: CONTACT

206-685-9655

Alexa Beaulieu, MPH

Role: CONTACT

253-261-8661

Facility Contacts

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Angela Ofori-Atta, PhD

Role: primary

Other Identifiers

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1R01MH127531-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00015549

Identifier Type: -

Identifier Source: org_study_id

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