Trial Outcomes & Findings for Development of a Mobile System for Self-management of Schizophrenia (SOS) (NCT NCT01969500)

NCT ID: NCT01969500

Last Updated: 2019-05-13

Results Overview

Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Baseline, week 12

Results posted on

2019-05-13

Participant Flow

Individuals with schizophrenia or schizoaffective disorder who were receiving services were recruited through flyers in waiting rooms and bulletin boards at treatment centers, and through referrals from clinical staff. Enrollment was open from November 2015 to July 2016.

N=3 enrolled participants were not assigned because N=1 did not pass a competency screener, N=1 did not meet Recovery Assessment Scale inclusion criteria, and N= 1 was no longer interested prior to completing baseline.

Participant milestones

Participant milestones
Measure	Treatment as Usual Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual	Mobile Application Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application
Overall Study STARTED	25	26
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment as Usual Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual	Mobile Application Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application
Overall Study Death	0	1
Overall Study extended hospitalization	1	1

Baseline Characteristics

N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment as Usual n=25 Participants Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual	Mobile Application n=26 Participants Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	25 Participants n=26 Participants	50 Participants n=51 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	1 Participants n=26 Participants	1 Participants n=51 Participants
Age, Continuous	43.0 years STANDARD_DEVIATION 12.5 • n=25 Participants	42.5 years STANDARD_DEVIATION 13.4 • n=26 Participants	42.7 years STANDARD_DEVIATION 12.8 • n=51 Participants
Sex: Female, Male Female	5 Participants n=25 Participants	11 Participants n=26 Participants	16 Participants n=51 Participants
Sex: Female, Male Male	20 Participants n=25 Participants	15 Participants n=26 Participants	35 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=25 Participants	1 Participants n=26 Participants	3 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=25 Participants	24 Participants n=26 Participants	47 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	1 Participants n=26 Participants	1 Participants n=51 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Black or African American	2 Participants n=25 Participants	1 Participants n=26 Participants	3 Participants n=51 Participants
Race (NIH/OMB) White	22 Participants n=25 Participants	24 Participants n=26 Participants	46 Participants n=51 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants	1 Participants n=26 Participants	2 Participants n=51 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Beliefs about Medicines Questionnaire - General (BMQ - General)	19.96 units on a scale STANDARD_DEVIATION 4.57 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	20.32 units on a scale STANDARD_DEVIATION 4.36 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	20.14 units on a scale STANDARD_DEVIATION 4.46 • n=50 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.
Beliefs about Medicines Questionnaire - Specific (BMQ - Specific)	32.56 units on a scale STANDARD_DEVIATION 5.24 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	32.20 units on a scale STANDARD_DEVIATION 4.49 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	32.38 units on a scale STANDARD_DEVIATION 4.86 • n=50 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.
Schizophrenia Patient Activation Measure (SPAM)	56.28 units on a scale STANDARD_DEVIATION 5.73 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	57.48 units on a scale STANDARD_DEVIATION 5.25 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	56.88 units on a scale STANDARD_DEVIATION 5.49 • n=50 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.
Beck Depression Inventory (BDI)	17.68 units on a scale STANDARD_DEVIATION 10.85 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	14.12 units on a scale STANDARD_DEVIATION 8.07 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	15.90 units on a scale STANDARD_DEVIATION 9.46 • n=50 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.
Insomnia Severity Index (ISI)	7.56 units on a scale STANDARD_DEVIATION 7.17 • n=25 Participants	6.73 units on a scale STANDARD_DEVIATION 5.68 • n=26 Participants	7.15 units on a scale STANDARD_DEVIATION 6.42 • n=51 Participants
Working Alliance Inventory (WAI)	64.68 units on a scale STANDARD_DEVIATION 12.93 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	66.28 units on a scale STANDARD_DEVIATION 11.43 • n=25 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.	65.48 units on a scale STANDARD_DEVIATION 12.18 • n=50 Participants • N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.

PRIMARY outcome

Timeframe: Baseline, week 12

Population: N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=25 Participants Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual	Mobile Application n=25 Participants Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application
Change in Severity of Psychotic Symptoms baseline	20.20 units on a scale Standard Error 3.20	19.88 units on a scale Standard Error 3.20
Change in Severity of Psychotic Symptoms 12 weeks	21.98 units on a scale Standard Error 3.24	20.96 units on a scale Standard Error 3.24

PRIMARY outcome

Timeframe: Baseline, week 12

Population: N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.

Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal \& Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=25 Participants Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual	Mobile Application n=25 Participants Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application
Change in Social Functioning baseline	27.60 units on a scale Standard Error 1.15	25.96 units on a scale Standard Error 1.15
Change in Social Functioning 12 weeks	29.28 units on a scale Standard Error 1.17	26.34 units on a scale Standard Error 1.17

SECONDARY outcome

Timeframe: 4 weeks

Population: This data was collected in a previous field trial, not in this randomized controlled trial.

System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: This data was collected in a previous field trial, not in this randomized controlled trial.

Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning.

Outcome measures

Outcome data not reported

Adverse Events

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mobile Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dror Ben-Zeev

University of Washington

Phone: (206) 685-9655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place