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

February 12, 2019 updated by: Dartmouth-Hitchcock Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Manchester, New Hampshire, United States, 03103
        • The Mental Health Center of Greater Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as Usual
Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
Behavioral: Treatment as Usual (TAU)
Experimental: Mobile Application
Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.
Behavioral: Mobile Application
Other Names:
  • Self-Management of Schizophrenia (SOS)
  • FOCUS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH100195-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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