Development of a Mobile System for Self-management of Schizophrenia (SOS)

Not Applicable

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Behavioral: Treatment as Usual (TAU); Behavioral: Mobile Application

• Registration Number: NCT01969500
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

This 2-arm clinical trial piloted a mobile Self-Management of Schizophrenia (SOS) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. Researchers compared an intervention arm using the SOS system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Study Start: 2015-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2018-08-01
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Results First Posted: 2019-05-13
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• DSM-IV (Diagnostic and Statistical Manual IV) criteria for schizophrenia or schizoaffective disorder based on a chart diagnosis;
• 18 years or older;
• Prescribed oral antipsychotic medication; and
• A rating of "3" or lower on one of the three items which comprise the Domination by Symptoms factor from the Recovery Assessment Scale, indicating patient-rated need for illness self-management

Exclusion Criteria

• Hearing, vision, or motor impairment that make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening); and
• English reading level below 4th grade (determined using the Wide Range Achievement Test - 4th Edition)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Treatment as Usual (TAU)	Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
Mobile Application	Mobile Application	Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.

Primary Outcome Measures

Name	Time	Method
Change in Social Functioning	Baseline, week 12	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.
Change in Severity of Psychotic Symptoms	Baseline, week 12	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.

Secondary Outcome Measures

Name	Time	Method
Usability and Satisfaction	4 weeks	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.
Change in System Use	4 weeks	System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system.

Trial Locations

Locations (1)

The Mental Health Center of Greater Manchester; 🇺🇸 Manchester, New Hampshire, United States