Schizophrenia
Conditions
Brief summary
Randomized control trial examining two mHealth intervention strategies.
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.
Interventions
DEVICEFOCUS
FOCUS is a self management mHealth application for people with serious mental illness.
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study. Inclusion: 1. Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder; 2. 18 years or older; 3. English-speaking; 4. Own a smartphone that can support FOCUS and active data plan. Exclusion: 1. Used FOCUS in the past; 2. Plan to move or discontinue services at participating clinics in the upcoming 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | 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) | 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. |
| Patient Health Questionnaire (PHQ)-9 | 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) | 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) | 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 | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Internal Facilitation mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS. | 117 |
| External Facilitation mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS. | 157 |
| Total | 274 |
Baseline characteristics
| Characteristic | Internal Facilitation | Total | External Facilitation |
|---|---|---|---|
| Age, Continuous | 43 Years STANDARD_DEVIATION 12 | 43.4 Years STANDARD_DEVIATION 11.8 | 43.6 Years STANDARD_DEVIATION 11.7 |
| Education Associate's degree | 22 Participants | 41 Participants | 19 Participants |
| Education Bachelor's degree or higher | 11 Participants | 25 Participants | 14 Participants |
| Education Grade school | 1 Participants | 3 Participants | 2 Participants |
| Education High school diploma/GED | 72 Participants | 181 Participants | 109 Participants |
| Education Junior high | 8 Participants | 17 Participants | 9 Participants |
| Education No formal school | 3 Participants | 6 Participants | 3 Participants |
| Education Unknown | 0 Participants | 1 Participants | 1 Participants |
| Employment Employed full time | 6 Participants | 17 Participants | 11 Participants |
| Employment Employed part time | 14 Participants | 26 Participants | 12 Participants |
| Employment Retired | 2 Participants | 7 Participants | 5 Participants |
| Employment Student | 5 Participants | 12 Participants | 7 Participants |
| Employment Unable to work / Disabled | 74 Participants | 176 Participants | 102 Participants |
| Employment Unemployed but looking for work | 14 Participants | 27 Participants | 13 Participants |
| Employment Unemployed but not looking for work | 2 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 33 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 235 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Housing Friend's home or apartment | 23 Participants | 54 Participants | 31 Participants |
| Housing Homeless | 2 Participants | 13 Participants | 11 Participants |
| Housing Mental health/substance use treatment facility or halfway house | 13 Participants | 28 Participants | 15 Participants |
| Housing Own/rent home or apartment | 78 Participants | 177 Participants | 99 Participants |
| Housing Unknown | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 29 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 31 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 81 Participants | 189 Participants | 108 Participants |
| Sex/Gender, Customized Gender Female | 45 Participants | 117 Participants | 72 Participants |
| Sex/Gender, Customized Gender Male | 64 Participants | 139 Participants | 75 Participants |
| Sex/Gender, Customized Gender Other | 4 Participants | 8 Participants | 4 Participants |
| Sex/Gender, Customized Gender Trandgender | 4 Participants | 8 Participants | 4 Participants |
| Sex/Gender, Customized Gender Unknown | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 176 | 0 / 123 |
| other Total, other adverse events | 0 / 176 | 0 / 123 |
| serious Total, serious adverse events | 0 / 176 | 0 / 123 |
Outcome results
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.
Time frame: 0,3,6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Generalized Anxiety Disorder-7 (GAD-7) | Baseline | 9.3 Scores on scale | Standard Error 0.5 |
| External Facilitation | Generalized Anxiety Disorder-7 (GAD-7) | 3M Follow-up | 7.6 Scores on scale | Standard Error 0.6 |
| External Facilitation | Generalized Anxiety Disorder-7 (GAD-7) | 6M Follow-up | 7.9 Scores on scale | Standard Error 0.7 |
| Internal Facilitation | Generalized Anxiety Disorder-7 (GAD-7) | Baseline | 9 Scores on scale | Standard Error 0.6 |
| Internal Facilitation | Generalized Anxiety Disorder-7 (GAD-7) | 3M Follow-up | 7.9 Scores on scale | Standard Error 0.6 |
| Internal Facilitation | Generalized Anxiety Disorder-7 (GAD-7) | 6M Follow-up | 7.6 Scores on scale | Standard Error 0.6 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.37adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.44Adjusted mixed-effects linear regression
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.
Time frame: 0,3,6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Green Paranoid Thoughts Scale- Part B | 6M Follow-up | 32.4 Scores on scale | Standard Error 1.9 |
| External Facilitation | Green Paranoid Thoughts Scale- Part B | Baseline | 31.8 Scores on scale | Standard Error 1.7 |
| External Facilitation | Green Paranoid Thoughts Scale- Part B | 3M Follow-up | 31.6 Scores on scale | Standard Error 1.8 |
| Internal Facilitation | Green Paranoid Thoughts Scale- Part B | Baseline | 32.5 Scores on scale | Standard Error 1.4 |
| Internal Facilitation | Green Paranoid Thoughts Scale- Part B | 3M Follow-up | 30.4 Scores on scale | Standard Error 1.6 |
| Internal Facilitation | Green Paranoid Thoughts Scale- Part B | 6M Follow-up | 30.1 Scores on scale | Standard Error 1.7 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.32Adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.16Adjusted mixed-effects linear regression
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.
Time frame: 0,3,6 Months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | Baseline | 14.3 Scores on scale | Standard Error 1 |
| External Facilitation | Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | 3M Follow-up | 13.6 Scores on scale | Standard Error 1.1 |
| External Facilitation | Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | 6M Follow-up | 13.0 Scores on scale | Standard Error 1.2 |
| Internal Facilitation | Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | Baseline | 13.8 Scores on scale | Standard Error 0.9 |
| Internal Facilitation | Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | 3M Follow-up | 12.5 Scores on scale | Standard Error 1 |
| Internal Facilitation | Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) | 6M Follow-up | 11.5 Scores on scale | Standard Error 1 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.63Adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.46Adjusted mixed-effects linear regression
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.
Time frame: 0,3,6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Illness Management and Recovery Scales (IMRS) | Baseline | 49.7 Scores on scale | Standard Error 0.7 |
| External Facilitation | Illness Management and Recovery Scales (IMRS) | 3M Follow-up | 51.0 Scores on scale | Standard Error 0.8 |
| External Facilitation | Illness Management and Recovery Scales (IMRS) | 6M Follow-up | 50.4 Scores on scale | Standard Error 0.8 |
| Internal Facilitation | Illness Management and Recovery Scales (IMRS) | Baseline | 49.8 Scores on scale | Standard Error 0.8 |
| Internal Facilitation | Illness Management and Recovery Scales (IMRS) | 3M Follow-up | 50.7 Scores on scale | Standard Error 0.9 |
| Internal Facilitation | Illness Management and Recovery Scales (IMRS) | 6M Follow-up | 51.2 Scores on scale | Standard Error 0.9 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.67Adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.53Adjusted mixed-effects linear regression
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.
Time frame: 0,3,6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Insomnia Severity Index (ISI) | Baseline | 12.4 Scores on scale | Standard Error 0.7 |
| External Facilitation | Insomnia Severity Index (ISI) | 3M Follow-up | 11.4 Scores on scale | Standard Error 0.8 |
| External Facilitation | Insomnia Severity Index (ISI) | 6M Follow-up | 12.6 Scores on scale | Standard Error 0.8 |
| Internal Facilitation | Insomnia Severity Index (ISI) | Baseline | 12.4 Scores on scale | Standard Error 0.6 |
| Internal Facilitation | Insomnia Severity Index (ISI) | 3M Follow-up | 11.9 Scores on scale | Standard Error 0.7 |
| Internal Facilitation | Insomnia Severity Index (ISI) | 6M Follow-up | 11.1 Scores on scale | Standard Error 0.7 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.619Adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.1Adjusted mixed-effects linear regression
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.
Time frame: 0,3,6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Patient Health Questionnaire (PHQ)-9 | Baseline | 11.6 Scores on scale | Standard Error 0.5 |
| External Facilitation | Patient Health Questionnaire (PHQ)-9 | 3M Follow-up | 9.6 Scores on scale | Standard Error 0.6 |
| External Facilitation | Patient Health Questionnaire (PHQ)-9 | 6M Follow-up | 9.3 Scores on scale | Standard Error 0.7 |
| Internal Facilitation | Patient Health Questionnaire (PHQ)-9 | Baseline | 10.7 Scores on scale | Standard Error 0.6 |
| Internal Facilitation | Patient Health Questionnaire (PHQ)-9 | 3M Follow-up | 10.2 Scores on scale | Standard Error 0.7 |
| Internal Facilitation | Patient Health Questionnaire (PHQ)-9 | 6M Follow-up | 9.4 Scores on scale | Standard Error 0.7 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.06adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.25Adjusted mixed-effects linear regression
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.
Time frame: 0,3,6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| External Facilitation | Symptom Check List (SCL-9) | Baseline | 13.7 Scores on scale | Standard Error 0.8 |
| External Facilitation | Symptom Check List (SCL-9) | 3M Follow-up | 11.2 Scores on scale | Standard Error 0.9 |
| External Facilitation | Symptom Check List (SCL-9) | 6M Follow-up | 10.7 Scores on scale | Standard Error 0.9 |
| Internal Facilitation | Symptom Check List (SCL-9) | Baseline | 13 Scores on scale | Standard Error 0.9 |
| Internal Facilitation | Symptom Check List (SCL-9) | 3M Follow-up | 11.7 Scores on scale | Standard Error 1 |
| Internal Facilitation | Symptom Check List (SCL-9) | 6M Follow-up | 11.3 Scores on scale | Standard Error 1 |
Comparison: Mixed-effects linear models were used to analyze within-person changes from baseline to 3 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.p-value: 0.31Adjusted mixed-effects linear regression
Comparison: 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.p-value: 0.28Adjusted mixed-effects linear regression