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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH116057-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Randomized control trial examining two mHealth intervention strategies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal Facilitation | Active Comparator | mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. |
|
| External Facilitation | Active Comparator | mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOCUS | Device | FOCUS is a self management mHealth application for people with serious mental illness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
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All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study.
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Dror Ben-Zeev, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cascade Mental Health Care | Chehalis | Washington | 98532 | United States | ||
| NEW Alliance Counseling Services |
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| ID | Title | Description |
|---|---|---|
| FG000 | External Facilitation | mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS. |
| FG001 | Internal Facilitation | mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled in study |
| ||||||||||||||||
| 3M Follow up |
| ||||||||||||||||
| 6M Follow Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Internal Facilitation | mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. |
| BG001 | External Facilitation | mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex/Gender, Customized | What best described you? |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 months |
|
Enrollment until end of follow-up, up to 24-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | External Facilitation | mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dror Ben-Zeev, Professor | University of Washington | 206-685-9655 | dbenzeev@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2024 | Sep 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2020 | Oct 19, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2020 | Sep 5, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| 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. | 0,3,6 months |
| Colville |
| Washington |
| 99114 |
| United States |
| Compass Health | Everett | Washington | 98201 | United States |
| Valley Cities | Federal Way | Washington | 98003 | United States |
| Peninsula Behavioral Health | Port Angeles | Washington | 98362 | United States |
| Sound Health | Seattle | Washington | 98125 | United States |
| Frontier Behavioral Health | Spokane | Washington | 99201 | United States |
| Comprehensive Healthcare | Yakima | Washington | 98902 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
Analyzed includes only those that completed baseline assessment
| Count of Participants |
| Participants |
|
| Race (NIH/OMB) | Analyzed includes only those that completed baseline assessment | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Analyzed includes only those that completed baseline assessment | Count of Participants | Participants |
|
| Education | What is the highest level of education you have completed? | Analyzed includes only those that completed baseline assessment | Count of Participants | Participants |
|
| Age, Continuous | Analyzed includes only those that completed baseline assessment | Mean | Standard Deviation | Years |
|
| Employment | What is your current employment status? | Analyzed includes only those that completed baseline assessment | Count of Participants | Participants |
|
| Housing | What best describes your current housing status? | Analyzed includes only those that completed baseline assessment | Count of Participants | Participants |
|
| OG001 | Internal Facilitation | mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. |
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 months |
|
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 months |
|
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 months |
|
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 months |
|
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 Months |
|
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Error | Scores on scale | 0,3,6 months |
|
|
|
|
| 0 |
| 176 |
| 0 |
| 176 |
| 0 |
| 176 |
| EG001 | Internal Facilitation | mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. | 0 | 123 | 0 | 123 | 0 | 123 |
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| 3M Follow-up |
|
|
| 6M Follow-up |
|
|
| Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast. | Adjusted mixed-effects linear regression | .44 | Difference-in-Difference | 0.6 | 2-Sided | Superiority | Cohen's d: 0.13 |
| 3M Follow-up |
|
|
| 6M Follow-up |
|
|
| Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast. | Adjusted mixed-effects linear regression | 0.10 | Difference-in-Difference | 1.5 | 2-Sided | Superiority | Cohen's d: 0.26 |
| 3M Follow-up |
|
|
| 6M Follow-up |
|
|
| Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast. | Adjusted mixed-effects linear regression | 0.16 | Difference-in-Difference | 3.0 | 2-Sided | Superiority | Cohen's d: 0.23 |
| 3M Follow-up |
|
|
| 6M Follow-up |
|
|
| Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast. | Adjusted mixed-effects linear regression | .28 | Difference-in-Difference | 1.3 | 2-Sided | Superiority | Cohen's d: 0.17 |
| 3M Follow-up |
|
|
| 6M Follow-up |
|
|
| Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast. | Adjusted mixed-effects linear regression | .46 | Difference-in-Difference | 0.9 | 2-Sided | Superiority | Cohen's d: 0.12 |
| 3M Follow-up |
|
|
| 6M Follow-up |
|
|
| Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast. | Adjusted mixed-effects linear regression | 0.53 | Difference-in-Difference | 0.7 | 2-Sided | Superiority | Cohen's d: 0.10 |