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

Primary Purpose

Psychosis, Mania, Depression

Status
Active
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
mHealer
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring mHealth, Psychosis, Mania, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Ghana

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Enhanced Usual Care

M&M Intervention Package

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Psychiatric symptoms
Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale
Depressive symptoms
Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
August 17, 2023
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05703711
Brief Title
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Official Title
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Mania, Depression
Keywords
mHealth, Psychosis, Mania, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
M&M Intervention Package
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mHealer
Intervention Description
MHealer is a software application installed on smartphones that provides psychosocial treatment support and patient condition tracking.
Primary Outcome Measure Information:
Title
Psychiatric symptoms
Description
Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Depressive symptoms
Description
Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9
Time Frame
Baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Ben-Zeev, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ghana
City
Accra
ZIP/Postal Code
GP4236
Country
Ghana

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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