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OpenTrials
Completed

NCT Number: NCT01969500

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

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.

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Key information

Conditions

Schizophrenia Behavior Health Behavior Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mobile application

Behavioral

Other names: Self-Management of Schizophrenia (SOS), FOCUS

Treatment as Usual (TAU)

Behavioral

Primary outcomes

  1. Change in Severity of Psychotic Symptoms

    Time frame: 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.

  2. Change in Social Functioning

    Time frame: 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.

Secondary outcomes

  1. Change in System Use

    Time frame: 4 weeks

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

  2. Usability and Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2013
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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