A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

N/ACompletedNCT01952041

Dartmouth-Hitchcock Medical Center149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

149

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

Device: SmartphoneBEHAVIORAL

Treatment as usualBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Zucker Hillside Hospital

Glen Oaks, New York, United States

Outcomes

Primary Outcomes

Relapses in Participants

A count of participants who experienced relapse, as defined as one of the following events: psychiatric hospitalization, a significant increase in the level of psychiatric care (i.e. frequency and intensity of services), an increase in medication in addition to a 25% increase in Brief Psychiatric Rating Scale (BPRS) from last assessment, suicidal or homicidal ideation that was clinically significant in the investigator's judgement, deliberate self-injury, violent behavior resulting in damage to another person or property.

Time frame: 1 year

Time to Relapse

Time to first relapse was defined as the time from randomization until the first relapse. Participants who did not experience a relapse were censored at their last known time relapse-free. Time-to-first relapse was estimated using the Kaplan-Meier method.

Time frame: From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study).

Secondary Outcomes

Psychotic Symptom Severity

Psychotic symptom severity assessed using the Brief Psychiatric Rating Scale (BPRS). This is an 18-item scale that rates severity of positive symptoms (including auditory hallucinations and persecutory ideation), and mood and behavioral symptoms. Items are rated by a clinical assessor on a scale of 1 (absent) to 7 (very severe). Total scores range from 18-126. Higher scores indicate worse symptoms.

Time frame: Assessed at baseline and every three months for one year.

Depression

Depression measured using the Calgary Depression Scales (CDSS). This is a 9-item assessment with values of 0 (absent) to 3 (severe) of depressive symptoms separate from positive, negative and extrapyramidal symptoms in people with schizophrenia. Total scores range from 0-27. A higher score indicates more severe symptoms.

Time frame: Assessed at baseline and every three months for one year.

Data from ClinicalTrials.gov

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