N/A
Completed N=126
A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia
Source: ClinicalTrials.gov NCT01952041 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Relapses in Participants — 20; 22 Participants — p=0.80
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapses in Participants |
20; 22 | 0.80 |
| PRIMARY Time to Relapse |
13.8; NA | 0.43 |
| SECONDARY Psychotic Symptom Severity |
26.3; 27.4; 24.9; 25.3; 25.3; 23.7 | 0.58 |
| SECONDARY Depression |
1.4; 2.1; 1.7; 1.7; 1.4; 1.7 | 0.84 |
| SECONDARY Social Functioning |
142.0; 135.1; 144.9; 140.0; 145.8; 140.1 | 0.06 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01952041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.