A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

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

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-13

Study Completion Date

2017-08-07

Brief Summary

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This study was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.

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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

Blinded clinical assessors also conducted assessments with all participants at baseline and every 3 months post-randomization.

Study Groups

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Device: Smartphone

Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.

Group Type EXPERIMENTAL

Device: Smartphone

Intervention Type BEHAVIORAL

Treatment as Usual

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

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Interventions

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Device: Smartphone

Intervention Type BEHAVIORAL

Treatment as usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis
* 18 years or older
* An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry
* Willing and able to provide informed consent

Exclusion Criteria

* Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening)
* 6th grade reading level (determined by Wide Range Achievement Test- 4th Edition)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No