Preliminary Efficacy of an mHealth Intervention in West Africa

We 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 randomized into one of three study conditions: 1) Treatment as usual; 2) FOCUS intervention; 3) G-FOCUS intervention.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenic Spectrum Disorder
• Intervention / Treatment: Other: FOCUS; Other: G-FOCUS

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexa Beaulieu; Phone Number: 253 261-8661; Email: beaulia@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

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 Schizophrenic Spectrum Disorder
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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
Active Comparator: FOCUS	Other: FOCUS; An evidence-based (USA populations tested) digital tool for serious mental illness.
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)	Depressive symptoms.	Baseline, 6 weeks, 12 weeks
Generalized Anxiety Disorder 7-item (GAD-7)	Anxiety severity	Baseline, 6 weeks, 12 weeks
Revised Green et al Paranoid Thoughts Scale		Baseline, 6 weeks, 12 weeks
Hamilton Program for Schizophrenia Voices Questionnaire		Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

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

Study record dates

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): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• 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