Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
Completed
Conditions studied: Schizophrenia, Schizoaffective Disorder
In brief
This study is dedicated to achieving a better understanding of how to identify patterns that indicate someone might be at high risk for relapse in schizophrenia or schizoaffective disorder. The investigators are utilizing smartphone technology along with on body sensors to achieve this goal. The study will observe participants behavior in their natural environment for a period of 16 weeks or until a signal of relapse is obtained. Participants will also complete scales in a clinical research environment biweekly.
Key facts
- Study ID
- NCT02224430
- Run by
- University of Alabama at Birmingham
- People needed
- 40
- Starts
- 2014-08-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2021-07-28
Who can join
Age: 19 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DSM - 5 criteria for schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual (DSM) criteria
- Males and females 19 years or older
- Discharged from the University of Alabama at Birmingham (UAB) inpatient psychiatric unit or the emergency department (ER) or currently seen by UAB outpatient physicians
- Prescribed and maintained on antipsychotic medication
- Psychiatrically stable for a period of at least two weeks
- Willingness and capability to comply with the study procedures, including responding to smartphone application prompts, wearing the optional on-body electronic devices
- Each participant must activate the Ginger.io User License Agreement (ULA) indicating that he or she understands how data security will be maintained on the smartphones.
- Each participant must sign an Informed Consent (ICF) indicating that he or she understands the purpose of the procedures required for the study and are willing to participate in the study
You may not qualify if…
- Physical and or clinical disabilities such as hearing, vision, or motor impairment, which make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening)
- Inability to understand the consent process as determined by the Evaluation to Give Consent
- Substance Use Disorder rating of severe (6 or more symptoms) according to the DSM-5
- Participants with any known skin allergy to the use of adhesives and/or lithium will be excluded from the optional Metria patch segment of the study
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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