NCT07276321

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Nov 2025Aug 2027

Study Start

First participant enrolled

November 3, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

November 18, 2025

Last Update Submit

December 9, 2025

Conditions

Schizophrenic Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

Treatment as Usual

NO INTERVENTION

FOCUS

ACTIVE COMPARATOR
Other: FOCUS

G-FOCUS

EXPERIMENTAL
Other: G-FOCUS

Interventions

G-FOCUSOTHER

A cultural adaption of an evidence-based (USA populations tested) digital tool for serious mental illness

G-FOCUS
FOCUSOTHER

An evidence-based (USA populations tested) digital tool for serious mental illness.

FOCUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accra Psychiatric Hospital

Accra, Ghana

RECRUITING

Study Officials

  • Dror Ben-Zeev, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa Beaulieu

CONTACT

253 261-8661beaulia@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor: School of Medicine, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 11, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

GH(1)