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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969500
• Other study ID #: MH100195-01
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Mobile Application

• Treatment as Usual (TAU)

Locations

Country	Name	City	State
United States	The Mental Health Center of Greater Manchester	Manchester	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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