SchizophreniaNCT05725785
Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness
A study testing FOCUS participants in people with Schizophrenia and Bipolar Disorder, run by University of Washington at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- FOCUS participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2023to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chart diagnosis of a serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)
- 18 years of age or older
- English-speaking
- Have access to a smartphone that can support FOCUS
Who cannot join
- Plan to move or discontinue services at the participating community mental health center in the next three months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Community Partners
Dover, New Hampshire, 03820
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03103
Places for People
St Louis, Missouri, 63118
About this study
The goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform.
Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.
Read the detailed description
Widely available technologies can help overcome the capacity constraints of brick-and mortar community mental health centers (CMHCs), expand the reach of evidence-based mental healthcare, and provide much needed illness management skills and resources for people with serious mental illness (SMI). With funding from the NIMH, PCORI, and CMMI, the investigators developed and tested FOCUS--a multi-modal smartphone illness self-management system that is shown to be feasible, usable, highly engaging, and effective among people with SMI.
The current project facilitates translation of FOCUS into routine care at CMHCs using implementation strategies of practice facilitation, implementation resource teams, and the development of accessible training materials. The investigators are proposing a technology-assisted training and implementation model designed to address system needs that have emerged since the COVID-19 pandemic and enhance sustainability of FOCUS at CMHCs. The new tools and strategies used in the project will facilitate improved training and implementation in new treatment settings, reaching a far larger number of patients who otherwise would not receive FOCUS and improving the sustainability of this tool, even in high turnover settings.
This trial is a prospective multi-site site single arm implementation study in three community mental health centers located in New Hampshire and Missouri. The investigators will develop and evaluate a digital training platform to aid in the implementation of FOCUS and utilize the platform to improve the availability, reach, impact, and sustainability of the FOCUS intervention in CMHCs. Patient participants will utilize FOCUS for a 12-week period at CMHCs where clinicians have been trained using the digital training platform. Investigators will compare patient outcomes to results of previous trials where clinicians were trained using more traditional, in-person training and support methods.
- Being tested
- FOCUS participants
- Keywords
- serious mental illness, mHealth, digital health, schizophrenia, implementation, smartphone, SMI
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUS participantsBehavioural
Participants using FOCUS will be given access to the FOCUS application and trained by the mHealth support specialist on how to use the functions of the smartphone (i.e. using a touchscreen, call, text) and different features of the FOCUS intervention.
| Study group | Role | What they receive |
|---|---|---|
| FOCUS participants | Other | FOCUS is a smartphone application system designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It delivers both system initiated (i.e. pre-programmed) and patient initiated (i.e. on demand) real-time assessment to individuals in their own environment. Receives: Behavioral: FOCUS participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychiatric functioning
Change in the psychiatric functioning will be measured by the Symptom Checklist-9 (SCL-9). This nine-item questionnaire is used to assess psychiatric functioning with a maximum score of 36 and a minimum score of 0. Higher scores on this scale indicates worse functioning.
Measured: Baseline, 3-months
Change in depressive symptoms
Change in the depressive symptoms will be measured by the Beck Depression Inventory-2 (BDI-2). This 21-item questionnaire is used to assess depressive symptoms with a maximum score of 63 and a minimum score of 0. Higher scores on this scale indicates worse functioning.
Measured: Baseline, 3-months
Change in auditory verbal hallucinations
Change in the auditory verbal hallucinations will be measured by the Hamilton Program for Schizophrenia Voices (HPSVQ). This 13-item questionnaire is used to assess auditory verbal hallucinations with a maximum score of 36 and a minimum score of 0. Higher scores on this scale indicate worse functioning.
Measured: Baseline, 3-months
Change in recovery oriented thinking
Recovery of patient will be measured using the Recovery Assessment Scale (RAS). RAS has 24-items that assess 5 factors related to recovery including Hope, Goal Directedness, and Domination by Symptoms. The maximum score on this scale is 120 and the minimum score is 24. A higher score on this scale indicated improved functioning.
Measured: Baseline, 3-months
Change in perceived quality of life
Quality of Life will be assessed using a 6-item Quality of Life scale of general wellbeing, interpersonal relations, participation in activities, and role functioning. Patients respond on a 7-point scale with a maximum score of 42 and a minimum score of 6. A higher score on this scale indicated a higher quality of life.
Measured: Baseline, 3-months
Patient Satisfaction with FOCUS
Patient satisfaction related to their use of the FOCUS system will will be assessed by a 5-item questionnaire on a 7-point scale asking about..... The maximum score on this scale is and the minimum is 35 and the minimum score on this scale is 5. A higher score on this scale indicates higher satisfaction with the FOCUS system.
Measured: 3-months
Patient Engagement with FOCUS
Patient engagement will be the number of weeks FOCUS was used, during the 12-week intervention period. Data for FOCUS usage will be captured automatically on FOCUS software.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Aug 2023
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- 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
- NCT05725785
- Sponsor's protocol ID
- STUDY00016266
- Other IDs
- DI-2021C3-24542
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05725785
- Acronym / sponsor ID
- STUDY00016266
- Keywords
- serious mental illness, mHealth, digital health, schizophrenia, implementation, smartphone, SMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 13 Feb 2023 (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 goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform.
Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.
Detailed description
Widely available technologies can help overcome the capacity constraints of brick-and mortar community mental health centers (CMHCs), expand the reach of evidence-based mental healthcare, and provide much needed illness management skills and resources for people with serious mental illness (SMI). With funding from the NIMH, PCORI, and CMMI, the investigators developed and tested FOCUS--a multi-modal smartphone illness self-management system that is shown to be feasible, usable, highly engaging, and effective among people with SMI.
The current project facilitates translation of FOCUS into routine care at CMHCs using implementation strategies of practice facilitation, implementation resource teams, and the development of accessible training materials. The investigators are proposing a technology-assisted training and implementation model designed to address system needs that have emerged since the COVID-19 pandemic and enhance sustainability of FOCUS at CMHCs. The new tools and strategies used in the project will facilitate improved training and implementation in new treatment settings, reaching a far larger number of patients who otherwise would not receive FOCUS and improving the sustainability of this tool, even in high turnover settings.
This trial is a prospective multi-site site single arm implementation study in three community mental health centers located in New Hampshire and Missouri. The investigators will develop and evaluate a digital training platform to aid in the implementation of FOCUS and utilize the platform to improve the availability, reach, impact, and sustainability of the FOCUS intervention in CMHCs. Patient participants will utilize FOCUS for a 12-week period at CMHCs where clinicians have been trained using the digital training platform. Investigators will compare patient outcomes to results of previous trials where clinicians were trained using more traditional, in-person training and support methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOCUS participants | Other | Behavioral: FOCUS participantsFOCUS is a smartphone application system designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It delivers both system initiated (i.e. pre-programmed) and patient initiated (i.e. on demand) real-time assessment to individuals in their own environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chart diagnosis of a serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)
- 18 years of age or older
- English-speaking
- Have access to a smartphone that can support FOCUS
Key exclusion criteria (1 listed)
- Plan to move or discontinue services at the participating community mental health center in the next three months
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 |
|---|---|---|
| FOCUS participantsParticipants using FOCUS will be given access to the FOCUS application and trained by the mHealth support specialist on how to use the functions of the smartphone (i.e. using a touchscreen, call, text) and different features of the FOCUS intervention. | Behavioural | FOCUS participants |
Primary outcome
Change in psychiatric functioning
Time frame: Baseline, 3-months
Change in the psychiatric functioning will be measured by the Symptom Checklist-9 (SCL-9). This nine-item questionnaire is used to assess psychiatric functioning with a maximum score of 36 and a minimum score of 0. Higher scores on this scale indicates worse functioning.
Change in depressive symptoms
Time frame: Baseline, 3-months
Change in the depressive symptoms will be measured by the Beck Depression Inventory-2 (BDI-2). This 21-item questionnaire is used to assess depressive symptoms with a maximum score of 63 and a minimum score of 0. Higher scores on this scale indicates worse functioning.
Change in auditory verbal hallucinations
Time frame: Baseline, 3-months
Change in the auditory verbal hallucinations will be measured by the Hamilton Program for Schizophrenia Voices (HPSVQ). This 13-item questionnaire is used to assess auditory verbal hallucinations with a maximum score of 36 and a minimum score of 0. Higher scores on this scale indicate worse functioning.
Change in recovery oriented thinking
Time frame: Baseline, 3-months
Recovery of patient will be measured using the Recovery Assessment Scale (RAS). RAS has 24-items that assess 5 factors related to recovery including Hope, Goal Directedness, and Domination by Symptoms. The maximum score on this scale is 120 and the minimum score is 24. A higher score on this scale indicated improved functioning.
Change in perceived quality of life
Time frame: Baseline, 3-months
Quality of Life will be assessed using a 6-item Quality of Life scale of general wellbeing, interpersonal relations, participation in activities, and role functioning. Patients respond on a 7-point scale with a maximum score of 42 and a minimum score of 6. A higher score on this scale indicated a higher quality of life.
Patient Satisfaction with FOCUS
Time frame: 3-months
Patient satisfaction related to their use of the FOCUS system will will be assessed by a 5-item questionnaire on a 7-point scale asking about..... The maximum score on this scale is and the minimum is 35 and the minimum score on this scale is 5. A higher score on this scale indicates higher satisfaction with the FOCUS system.
Patient Engagement with FOCUS
Time frame: 3-months
Patient engagement will be the number of weeks FOCUS was used, during the 12-week intervention period. Data for FOCUS usage will be captured automatically on FOCUS software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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. This study is not recruiting at the moment.
Dror Ben Zeev, PhD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS participants in people with Schizophrenia and Bipolar Disorder, run by University of Washington at 3 sites in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychiatric functioning (time frame: Baseline, 3-months). The study lists 7 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 4 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.