NCT01969500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
2 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 13, 2019

Completed
Last Updated

May 13, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

October 15, 2013

Results QC Date

August 1, 2018

Last Update Submit

February 12, 2019

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffective DisorderSelf Management of SchizophreniaSOSSerious Mental IllnessPsychosisSocial DysfunctionMedication AdherenceMobile ApplicationEHealthE-HealthHealth Technologymobile healthm-Healthelectronic health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in System Use

    4 weeks

  • Usability and Satisfaction

    4 weeks

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual (TAU)

Mobile Application

EXPERIMENTAL

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

Behavioral: Mobile Application

Interventions

Mobile ApplicationBEHAVIORAL
Also known as: Self-Management of Schizophrenia (SOS), FOCUS
Mobile Application
Treatment as Usual (TAU)BEHAVIORAL
Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV (Diagnostic and Statistical Manual IV) criteria for schizophrenia or schizoaffective disorder based on a chart diagnosis;
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMedication Adherence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dror Ben-Zeev
Organization
University of Washington
dbenzeev@uw.edu
(206) 685-9655

Study Officials

  • Dror Ben-Zeev, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 25, 2013

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 13, 2019

Results First Posted

May 13, 2019

Record last verified: 2019-02

Locations

US(1)