N/A
N=126
A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01952041 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Relapses in Participants — 20; 22 Participants — p=0.80
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device: Smartphone (Behavioral); Treatment as usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Aug 2017
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 |
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.
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.