PsychosisNCT07276321
Preliminary Efficacy of an mHealth Intervention in West Africa
A study testing G-FOCUS in people with Psychosis, run by University of Washington at 1 site in Ghana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- G-FOCUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGhana
- Study dates
- 3 Nov 2025to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years of age or older
- Speaks English
- Outpatient receiving care at Accra Psychiatric Hospital
- Diagnosis of psychosis and are currently symptomatic as assessed by administering the psychosis section of the MINI (Mini International Neuropsychiatric Interview)
- Owns a mobile device capable of downloading smartphone applications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ghana1 site, 1 recruiting
- Recruiting
Accra Psychiatric Hospital
Accra
Kwadwo Obeng, MBChB, MGCP, FGCP, +233 20 253 6108, drkobeng@gmail.com
About this study
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.
- Conditions
- Psychosis
- Being tested
- G-FOCUS
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-FOCUSOther
A cultural adaption of an evidence-based (USA populations tested) digital tool for serious mental illness
| Study group | Role | What they receive |
|---|---|---|
| G-FOCUS | Experimental | Not described Receives: Other: G-FOCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms.
Measured: Baseline, 6 weeks, 12 weeks
Generalized Anxiety Disorder 7-item (GAD-7)
Anxiety severity
Measured: Baseline, 6 weeks, 12 weeks
Revised Green et al Paranoid Thoughts Scale
Measured: Baseline, 6 weeks, 12 weeks
Hamilton Program for Schizophrenia Voices Questionnaire
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start3 Nov 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Ben-Zeev, University of Washington
- Investigators
- Dror Ben-Zeev, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276321
- Sponsor's protocol ID
- STUDY00023050
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of an mHealth Intervention in West Africa
- ClinicalTrials.gov ID
- NCT07276321
- Acronym / sponsor ID
- STUDY00023050
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G-FOCUS | Experimental | Other: G-FOCUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years of age or older
- Speaks English
- Outpatient receiving care at Accra Psychiatric Hospital
- Diagnosis of psychosis and are currently symptomatic as assessed by administering the psychosis section of the MINI (Mini International Neuropsychiatric Interview)
- Owns a mobile device capable of downloading smartphone applications
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-FOCUSA cultural adaption of an evidence-based (USA populations tested) digital tool for serious mental illness | Other | G-FOCUS |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dror Ben-Zeev, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-FOCUS in people with Psychosis, run by University of Washington at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalynn Howard (253 261-8661, shahow@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline, 6 weeks, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.