SchizophreniaNCT04147897

Implementing mHealth for Schizophrenia in Community Mental Health Settings

A study testing FOCUS in people with Schizophrenia, run by University of Washington at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized control trial examining two mHealth intervention strategies. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Schizophrenia
What is being tested?: FOCUS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 8 sitesUnited States
Study dates: 16 Jun 2020to 16 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;
18 years or older;
English-speaking;
Own a smartphone that can support FOCUS and active data plan.

Who cannot join

Used FOCUS in the past;
Plan to move or discontinue services at participating clinics in the upcoming 6 months.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Cascade Mental Health Care
Chehalis, Washington, 98532
NEW Alliance Counseling Services
Colville, Washington, 99114
Compass Health
Everett, Washington, 98201
Valley Cities
Federal Way, Washington, 98003
Peninsula Behavioral Health
Port Angeles, Washington, 98362
Sound Health
Seattle, Washington, 98125
Frontier Behavioral Health
Spokane, Washington, 99201
Comprehensive Healthcare
Yakima, Washington, 98902

Other trials in United States

About this study

Randomized control trial examining two mHealth intervention strategies.

Read the detailed description

The investigators will conduct a multi-site site hybrid type III effectiveness/implementation study in Washington State. The study involves a systematic head-to-head comparison between External Facilitation (EF) and Internal Facilitation (IF) implementation models applied to the FOCUS mHealth intervention.

Conditions: Schizophrenia
Being tested: FOCUS
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOCUSDevice
FOCUS is a self management mHealth application for people with serious mental illness.

Study groups in NCT04147897
Study group	Role	What they receive
Internal Facilitation	Active comparator	mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. Receives: Device: FOCUS
External Facilitation	Active comparator	mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS. Receives: Device: FOCUS

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Health Questionnaire (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. Total scores range from 0-27. Higher scores represent more severe symptoms.
Measured: 0,3,6 months
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) measures generalized anxiety disorder symptoms. GAD-7 total score ranges from 0 to 21. Higher scores represent more severe symptoms.
Measured: 0,3,6 months
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a brief screening assessment tool designed to evaluate insomnia. Total scores range from 0-28. Higher scores represent more severe symptoms.
Measured: 0,3,6 months
Green Paranoid Thoughts Scale- Part B
The Green Paranoid Thoughts Scale (GPTS)- part B measures ideas of persecution. Scores range from 16-80. Higher scores represent more severe symptoms.
Measured: 0,3,6 months
Symptom Check List (SCL-9)
The Symptom Check List-9 (SCL-9) is a brief version of the SCL-90, which aims to evaluate a broad range of psychological problems and symptoms of psychopathology. Total scores are calculated as sum of all responses. Total sum scores range from 0-36. Higher scores mean more severe symptoms.
Measured: 0,3,6 months
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
A 9-item measure specifically designed to quantify characteristics of auditory hallucinations including frequency, negative content, loudness, duration, interference with life, distress, impact on self-appraisal, and compliance with commands. Total score is a sum of all 9 items. Total HPSVQ scores range from 0-36. Higher scores mean more severe symptoms.
Measured: 0,3,6 Months
Illness Management and Recovery Scales (IMRS)
The Illness Management and Recovery Scales (IMRS) measure illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean less severe symptoms.
Measured: 0,3,6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 202016 Sep 2024

First posted1 Nov 2019
Study start16 Jun 2020
Primary completion16 Sep 2024
Study completion16 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04147897
Sponsor's protocol ID: STUDY00006141
Other IDs: 1R01MH116057-01A1
Status last verified: Nov 2025
First submitted: 14 Oct 2019
Last updated: 24 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Levin CE, Tauscher J, Meller S, Brian RM, Buck BE, Ben-Zeev D. Cost of Implementing mHealth in Community Mental Health Settings: External Versus Internal Facilitation. Psychiatr Serv. 2024 Apr 1;75(4):357-362. doi: 10.1176/appi.ps.20230140. Epub 2023 Oct 26.
PubMed 37880968

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing mHealth for Schizophrenia in Community Mental Health Settings
ClinicalTrials.gov ID: NCT04147897
Acronym / sponsor ID: STUDY00006141
Conditions: Schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 16 Jun 2020 (actual)
Primary completion: 16 Sep 2024 (actual)
Study completion: 16 Sep 2024 (actual)
First posted: 1 Nov 2019 (actual)
Results: Posted 24 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized control trial examining two mHealth intervention strategies.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Internal Facilitation	Active comparator	Device: FOCUSmHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
External Facilitation	Active comparator	Device: FOCUSmHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;
18 years or older;
English-speaking;
Own a smartphone that can support FOCUS and active data plan.

Key exclusion criteria (2 listed)

Used FOCUS in the past;
Plan to move or discontinue services at participating clinics in the upcoming 6 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
FOCUSFOCUS is a self management mHealth application for people with serious mental illness.	Device	External Facilitation, Internal Facilitation

Primary outcome

Patient Health Questionnaire (PHQ)-9
Time frame: 0,3,6 months
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. Total scores range from 0-27. Higher scores represent more severe symptoms.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0,3,6 months
The Generalized Anxiety Disorder-7 (GAD-7) measures generalized anxiety disorder symptoms. GAD-7 total score ranges from 0 to 21. Higher scores represent more severe symptoms.
Insomnia Severity Index (ISI)
Time frame: 0,3,6 months
The Insomnia Severity Index (ISI) is a brief screening assessment tool designed to evaluate insomnia. Total scores range from 0-28. Higher scores represent more severe symptoms.
Green Paranoid Thoughts Scale- Part B
Time frame: 0,3,6 months
The Green Paranoid Thoughts Scale (GPTS)- part B measures ideas of persecution. Scores range from 16-80. Higher scores represent more severe symptoms.
Symptom Check List (SCL-9)
Time frame: 0,3,6 months
The Symptom Check List-9 (SCL-9) is a brief version of the SCL-90, which aims to evaluate a broad range of psychological problems and symptoms of psychopathology. Total scores are calculated as sum of all responses. Total sum scores range from 0-36. Higher scores mean more severe symptoms.
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
Time frame: 0,3,6 Months
A 9-item measure specifically designed to quantify characteristics of auditory hallucinations including frequency, negative content, loudness, duration, interference with life, distress, impact on self-appraisal, and compliance with commands. Total score is a sum of all 9 items. Total HPSVQ scores range from 0-36. Higher scores mean more severe symptoms.
Illness Management and Recovery Scales (IMRS)
Time frame: 0,3,6 months
The Illness Management and Recovery Scales (IMRS) measure illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean less severe symptoms.

Results and safety

Results posted to the registry on 24 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
External Facilitation	176	157
Internal Facilitation	123	117

Primary outcome: Patient Health Questionnaire (PHQ)-9

Time frame: 0,3,6 months. Mean (Standard Error). Unit: Scores on scale

Measure	External Facilitation n = 157	Internal Facilitation n = 117
Baseline	11.6 (0.5)	10.7 (0.6)
3M Follow-up	9.6 (0.6)	10.2 (0.7)
6M Follow-up	9.3 (0.7)	9.4 (0.7)

External Facilitation vs Internal Facilitation: Difference in Difference: 1.5, p = .06, adjusted mixed-effects linear regression
External Facilitation vs Internal Facilitation: Difference-in-Difference: 1.0, p = .25, Adjusted mixed-effects linear regression

Population analysed: Baseline analyses include only those participants who completed baseline assessments (N=274; EF=157, IF=117). Participants who did not complete baseline assessments were excluded from analysis. 3M analyses include only those participants who completed 3M follow-up assessments (N= 186, EF=101, IF=85). 6M analyses include only those participants who completed 6M assessments (N=152, EF=82, IF=70).

Primary outcome: Generalized Anxiety Disorder-7 (GAD-7)

Time frame: 0,3,6 months. Mean (Standard Error). Unit: Scores on scale

Measure	External Facilitation n = 157	Internal Facilitation n = 117
Baseline	9.3 (0.5)	9 (0.6)
3M Follow-up	7.6 (0.6)	7.9 (0.6)
6M Follow-up	7.9 (0.7)	7.6 (0.6)

External Facilitation vs Internal Facilitation: difference in difference: 0.7, p = 0.37, adjusted mixed-effects linear regression
External Facilitation vs Internal Facilitation: Difference-in-Difference: 0.6, p = .44, Adjusted mixed-effects linear regression

Primary outcome: Insomnia Severity Index (ISI)

Time frame: 0,3,6 months. Mean (Standard Error). Unit: Scores on scale

Measure	Internal Facilitation n = 117	External Facilitation n = 157
Baseline	12.4 (0.7)	12.4 (0.6)
3M Follow-up	11.4 (0.8)	11.9 (0.7)
6M Follow-up	12.6 (0.8)	11.1 (0.7)

Internal Facilitation vs External Facilitation: Difference-in-Difference: -0.4, p = .619, Adjusted mixed-effects linear regression
Internal Facilitation vs External Facilitation: Difference-in-Difference: 1.5, p = 0.10, Adjusted mixed-effects linear regression

Primary outcome: Green Paranoid Thoughts Scale- Part B

Time frame: 0,3,6 months. Mean (Standard Error). Unit: Scores on scale

Measure	Internal Facilitation n = 117	External Facilitation n = 157
Baseline	31.8 (1.7)	32.5 (1.4)
3M Follow-up	31.6 (1.8)	30.4 (1.6)
6M Follow-up	32.4 (1.9)	30.1 (1.7)

Internal Facilitation vs External Facilitation: Difference-in-Difference: 1.9, p = .32, Adjusted mixed-effects linear regression
Internal Facilitation vs External Facilitation: Difference-in-Difference: 3.0, p = 0.16, Adjusted mixed-effects linear regression

Adverse events

Time frame: Enrollment until end of follow-up, up to 24-weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
External Facilitation	0 of 176 (0%)	0 of 176 (0%)	0 of 176
Internal Facilitation	0 of 123 (0%)	0 of 123 (0%)	0 of 123

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37880968Levin CE, Tauscher J, Meller S, Brian RM, Buck BE, Ben-Zeev D. Cost of Implementing mHealth in Community Mental Health Settings: External Versus Internal Facilitation. Psychiatr Serv. 2024 Apr 1;75(4):357-362. doi: 10.1176/appi.ps.20230140. Epub 2023 Oct 26.
Individual participant dataSharing planned: No

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
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Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FOCUS in people with Schizophrenia, run by University of Washington at 8 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 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: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Health Questionnaire (PHQ)-9 (time frame: 0,3,6 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?

On the ClinicalTrials.gov record for NCT04147897, which also lists 1 linked publication.

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 24 Nov 2025.