Preliminary Efficacy of an mHealth Intervention in West Africa

August 31, 2026 updated by: Dror Ben-Zeev, University of Washington

The investigators are conducting a pilot feasibility and preliminary efficacy trial of a digital intervention for serious mental illness in West Africa.

Participants will be recruited from a large psychiatric hospital in Ghana and will be asked to use a digital intervention titled G-FOCUS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

Study Contact Backup

  • Name: Shalynn Howard
  • Phone Number: 253 261-8661
  • Email: shahow@uw.edu

Study Locations

  • Ghana
      • Accra, Ghana
        • Recruiting
        • Accra Psychiatric Hospital
        • Contact:
          • Kwadwo Obeng, MBChB, MGCP, FGCP
          • Phone Number: +233 20 253 6108
          • Email: drkobeng@gmail.com

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years of age or older
  2. Speaks English
  3. Outpatient receiving care at Accra Psychiatric Hospital
  4. Diagnosis of psychosis and are currently symptomatic as assessed by administering the psychosis section of the MINI (Mini International Neuropsychiatric Interview)
  5. Owns a mobile device capable of downloading smartphone applications

Exclusion Criteria:

  1. Hearing, vision, or motor impairment that would hamper their ability to participate in data collection
  2. Serious intellectual or developmental disability that would hamper their ability to participate in data collection

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G-FOCUS
Other: G-FOCUS
A cultural adaption of an evidence-based (USA populations tested) digital tool for serious mental illness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 6 weeks, 12 weeks
Depressive symptoms.
Baseline, 6 weeks, 12 weeks
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Baseline, 6 weeks, 12 weeks
Anxiety severity
Baseline, 6 weeks, 12 weeks
Revised Green et al Paranoid Thoughts Scale
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
Hamilton Program for Schizophrenia Voices Questionnaire
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

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

Sponsor

University of Washington

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)

November 3, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00023050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

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