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

N/ACompletedNCT01969500

Dartmouth-Hitchcock Medical Center51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

Mobile ApplicationBEHAVIORAL

Treatment as Usual (TAU)BEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Outcomes

Primary Outcomes

Change in Severity of Psychotic Symptoms

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.

Time frame: Baseline, week 12

Change in Social Functioning

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.

Time frame: Baseline, week 12

Secondary Outcomes

Change in System Use

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

Time frame: 4 weeks

Usability and Satisfaction

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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