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Clinical Trials/NCT07276321
NCT07276321
Recruiting
Not Applicable

Preliminary Efficacy of an mHealth Intervention in West Africa

University of Washington1 site in 1 country150 target enrollmentStarted: November 3, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
Patient Health Questionnaire-9 (PHQ-9)

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 18 years of age or older
  • Speaks English
  • Outpatient receiving care at Accra Psychiatric Hospital
  • Diagnosis of Schizophrenic Spectrum Disorder
  • Owns a mobile device capable of downloading smartphone applications

Exclusion Criteria

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

Outcomes

Primary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Baseline, 6 weeks, 12 weeks

Depressive symptoms.

Generalized Anxiety Disorder 7-item (GAD-7)

Time Frame: Baseline, 6 weeks, 12 weeks

Anxiety severity

Revised Green et al Paranoid Thoughts Scale

Time Frame: Baseline, 6 weeks, 12 weeks

Hamilton Program for Schizophrenia Voices Questionnaire

Time Frame: Baseline, 6 weeks, 12 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dror Ben-Zeev

Professor: School of Medicine, Psychiatry and Behavioral Sciences

University of Washington

Study Sites (1)

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