Back to resultsDevelopment of a Mobile System for Self-management of Schizophrenia (SOS)
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Application
Treatment as Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Self Management of Schizophrenia, SOS, Serious Mental Illness, Psychosis, Social Dysfunction, Medication Adherence, Mobile Application, EHealth, E-Health, Health Technology, mobile health, m-Health, electronic health
Eligibility Criteria
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)
Sites / Locations
- The Mental Health Center of Greater Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as Usual
Mobile Application
Arm Description
Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01969500
First Posted
October 15, 2013
Last Updated
February 12, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01969500
Brief Title
Development of a Mobile System for Self-management of Schizophrenia (SOS)
Official Title
Development of a Mobile System for Self-management of Schizophrenia (SOS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Self Management of Schizophrenia, SOS, Serious Mental Illness, Psychosis, Social Dysfunction, Medication Adherence, Mobile Application, EHealth, E-Health, Health Technology, mobile health, m-Health, electronic health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
Arm Title
Mobile Application
Arm Type
Experimental
Arm Description
Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Application
Other Intervention Name(s)
Self-Management of Schizophrenia (SOS), FOCUS
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Primary Outcome Measure Information:
Title
Change in Severity of Psychotic Symptoms
Description
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
Title
Change in Social Functioning
Description
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 Outcome Measure Information:
Title
Change in System Use
Description
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
Title
Usability and Satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Ben-Zeev, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of a Mobile System for Self-management of Schizophrenia (SOS)
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