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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: Mobile Application
* Behavioral: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as Usual<br>Treatment as usual includes outpatient case management, linkage to services and medication monitoring. | Behavioral: Treatment as Usual (TAU)<br> <br> |
| Experimental: Mobile Application<br>Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. | Behavioral: Mobile Application<br> <br> * Other names: FOCUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serious Mental Illness, Social Dysfunction, Medication Adherence, Mobile Application, EHealth, E-Health, Health Technology, mobile health, m-Health, electronic health, Schizophrenia, Schizoaffective Disorder, Self Management of Schizophrenia, SOS, Psychosis