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

NCT ID: NCT01969500

Last Updated: 2019-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

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.

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment as Usual

Treatment as usual includes outpatient case management, linkage to services and medication monitoring.

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

Mobile Application

Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.

Group Type EXPERIMENTAL

Mobile Application

Intervention Type BEHAVIORAL

Interventions

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Mobile Application

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

Other Intervention Names

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Self-Management of Schizophrenia (SOS) FOCUS

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dror Ben-Zeev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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The Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MH100195-01

Identifier Type: -

Identifier Source: org_study_id

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