Preliminary Efficacy of an mHealth Intervention in West A... | NCT07276321

Studies
Preliminary Efficacy of an mHealth Intervention in West Africa

NCT07276321

Sponsor

University of Washington

Status

Recruiting

Last Update Posted

Dec 11, 2025Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Schizophrenic Spectrum Disorder

Interventions

G-FOCUS
FOCUS

Countries

Ghana

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2025Actual

Primary Completion Date

Aug 30, 2027Estimated

Completion Date

Aug 30, 2027Estimated

First Submitted Date

Nov 18, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2025

Last Update Posted Date

Dec 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dror Ben-Zeev, Professor: School of Medicine, Psychiatry and Behavioral Sciences, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Treatment as Usual	No Intervention
FOCUS	Active Comparator	Other: FOCUS
G-FOCUS	Experimental	Other: G-FOCUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-FOCUS	Other	A cultural adaption of an evidence-based (USA populations tested) digital tool for serious mental illness	G-FOCUS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexa Beaulieu	Contact	253 261-8661		beaulia@uw.edu

Overall Officials

Name	Affiliation	Role
Dror Ben-Zeev, PhD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Accra Psychiatric Hospital	Recruiting	Accra			Ghana

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided