Trial Outcomes & Findings for Implementing mHealth for Schizophrenia in Community Mental Health Settings (NCT NCT04147897)

Last Updated: 2025-11-24

Results Overview

The Green Paranoid Thoughts Scale (GPTS)- part B measures ideas of persecution. Scores range from 16-80. Higher scores represent more severe symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

299 participants

Primary outcome timeframe

0,3,6 months

Results posted on

2025-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	External Facilitation mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Enrolled in study STARTED	176	123
Enrolled in study Completed baseline	157	117
Enrolled in study COMPLETED	157	117
Enrolled in study NOT COMPLETED	19	6
3M Follow up STARTED	157	117
3M Follow up COMPLETED	101	85
3M Follow up NOT COMPLETED	56	32
6M Follow Up STARTED	101	85
6M Follow Up COMPLETED	82	70
6M Follow Up NOT COMPLETED	19	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analyzed includes only those that completed baseline assessment

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	External Facilitation n=157 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=117 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Patient Health Questionnaire (PHQ)-9 Baseline	11.6 Scores on scale Standard Error 0.5	10.7 Scores on scale Standard Error 0.6
Patient Health Questionnaire (PHQ)-9 3M Follow-up	9.6 Scores on scale Standard Error 0.6	10.2 Scores on scale Standard Error 0.7
Patient Health Questionnaire (PHQ)-9 6M Follow-up	9.3 Scores on scale Standard Error 0.7	9.4 Scores on scale Standard Error 0.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	External Facilitation n=157 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=117 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Generalized Anxiety Disorder-7 (GAD-7) Baseline	9.3 Scores on scale Standard Error 0.5	9 Scores on scale Standard Error 0.6
Generalized Anxiety Disorder-7 (GAD-7) 3M Follow-up	7.6 Scores on scale Standard Error 0.6	7.9 Scores on scale Standard Error 0.6
Generalized Anxiety Disorder-7 (GAD-7) 6M Follow-up	7.9 Scores on scale Standard Error 0.7	7.6 Scores on scale Standard Error 0.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	External Facilitation n=117 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=157 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Insomnia Severity Index (ISI) Baseline	12.4 Scores on scale Standard Error 0.7	12.4 Scores on scale Standard Error 0.6
Insomnia Severity Index (ISI) 3M Follow-up	11.4 Scores on scale Standard Error 0.8	11.9 Scores on scale Standard Error 0.7
Insomnia Severity Index (ISI) 6M Follow-up	12.6 Scores on scale Standard Error 0.8	11.1 Scores on scale Standard Error 0.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	External Facilitation n=117 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=157 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Green Paranoid Thoughts Scale- Part B 3M Follow-up	31.6 Scores on scale Standard Error 1.8	30.4 Scores on scale Standard Error 1.6
Green Paranoid Thoughts Scale- Part B 6M Follow-up	32.4 Scores on scale Standard Error 1.9	30.1 Scores on scale Standard Error 1.7
Green Paranoid Thoughts Scale- Part B Baseline	31.8 Scores on scale Standard Error 1.7	32.5 Scores on scale Standard Error 1.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	External Facilitation n=157 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=117 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Symptom Check List (SCL-9) Baseline	13.7 Scores on scale Standard Error 0.8	13 Scores on scale Standard Error 0.9
Symptom Check List (SCL-9) 3M Follow-up	11.2 Scores on scale Standard Error 0.9	11.7 Scores on scale Standard Error 1.0
Symptom Check List (SCL-9) 6M Follow-up	10.7 Scores on scale Standard Error 0.9	11.3 Scores on scale Standard Error 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	External Facilitation n=117 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=157 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) Baseline	14.3 Scores on scale Standard Error 1.0	13.8 Scores on scale Standard Error 0.9
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) 3M Follow-up	13.6 Scores on scale Standard Error 1.1	12.5 Scores on scale Standard Error 1.0
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) 6M Follow-up	13.0 Scores on scale Standard Error 1.2	11.5 Scores on scale Standard Error 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	External Facilitation n=157 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Internal Facilitation n=117 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Illness Management and Recovery Scales (IMRS) Baseline	49.7 Scores on scale Standard Error 0.7	49.8 Scores on scale Standard Error 0.8
Illness Management and Recovery Scales (IMRS) 3M Follow-up	51.0 Scores on scale Standard Error 0.8	50.7 Scores on scale Standard Error 0.9
Illness Management and Recovery Scales (IMRS) 6M Follow-up	50.4 Scores on scale Standard Error 0.8	51.2 Scores on scale Standard Error 0.9

Adverse Events

External Facilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Internal Facilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dror Ben-Zeev, Professor

University of Washington

Phone: 206-685-9655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Internal Facilitation n=117 Participants mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.	External Facilitation n=157 Participants mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Total n=274 Participants Total of all reporting groups
Sex/Gender, Customized Gender · Male	64 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	75 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	139 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Sex/Gender, Customized Gender · Female	45 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	72 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	117 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Sex/Gender, Customized Gender · Trandgender	4 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	4 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	8 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Sex/Gender, Customized Gender · Other	4 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	4 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	8 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Sex/Gender, Customized Gender · Unknown	0 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	2 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	2 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	9 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	12 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) Asian	3 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	2 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	5 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	3 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	6 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) Black or African American	12 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	17 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	29 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) White	81 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	108 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	189 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) More than one race	13 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	18 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	31 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	0 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	2 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	17 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	33 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	136 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	235 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	4 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	6 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education No formal school	3 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	3 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	6 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education Grade school	1 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	2 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	3 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education Junior high	8 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	9 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	17 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education High school diploma/GED	72 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	109 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	181 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education Associate's degree	22 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	19 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	41 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education Bachelor's degree or higher	11 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	14 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	25 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Education Unknown	0 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	1 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	1 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Age, Continuous	43 Years STANDARD_DEVIATION 12 • n=45 Participants • Analyzed includes only those that completed baseline assessment	43.6 Years STANDARD_DEVIATION 11.7 • n=12929 Participants • Analyzed includes only those that completed baseline assessment	43.4 Years STANDARD_DEVIATION 11.8 • n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Unable to work / Disabled	74 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	102 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	176 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Unemployed but looking for work	14 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	13 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	27 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Unemployed but not looking for work	2 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	7 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	9 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Employed full time	6 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	11 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	17 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Employed part time	14 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	12 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	26 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Student	5 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	7 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	12 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Employment Retired	2 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	5 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	7 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Housing Own/rent home or apartment	78 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	99 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	177 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Housing Friend's home or apartment	23 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	31 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	54 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Housing Mental health/substance use treatment facility or halfway house	13 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	15 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	28 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Housing Homeless	2 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	11 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	13 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment
Housing Unknown	1 Participants n=45 Participants • Analyzed includes only those that completed baseline assessment	1 Participants n=12929 Participants • Analyzed includes only those that completed baseline assessment	2 Participants n=6349 Participants • Analyzed includes only those that completed baseline assessment