Is Cognitive Training Neuroprotective in Early Psychosis?
Completed
Conditions studied: Psychosis, Healthy
In brief
The purpose of this study is to perform longitudinal high-resolution 7T MRI and Prisma 3T MRI in participants with first-episode psychosis (FEP) enrolled in our ongoing randomized controlled clinical trial (RCT) of cognitive training. The investigators seek to determine whether a 12-week course of intensive cognitive training of auditory processing in young FEP patients delivered remotely as a stand-alone treatment is neuroprotective against neural tissue loss in auditory cortex (superior temporal gyrus, STG), and possibly in other cortical regions. The investigators will also observe the effects of training on white matter integrity in the brain.
Key facts
- Study ID
- NCT03049800
- Run by
- University of Minnesota
- People needed
- 36
- Starts
- 2017-06-12
- Expected to finish
- 2021-02-15
- Last updated by the study team
- 2021-02-16
Who can join
Age: 16 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Enrolled in the Mini-COTES randomized controlled trial examining cognitive training in First Episode Psychosis (NCT03079024)
- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
- Good general physical health
- Age between 16 and 35 (inclusive)
- Fluent in written and spoken English
- No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
- Achieved clinical stability, defined as outpatient status for at least one month prior to study participation, stable doses of psychiatric medications for at least one month prior to study participation
- Women who are pregnant or breastfeeding may participate in this study
- Healthy Controls (HC) Participants
- Inclusion Criteria:
- Age between 16 and 35 (inclusive)
- Fluent in English
- Good general physical health
- No neurological disorder
- No current or past diagnosis of a psychotic disorder, mood disorder, or anxiety disorder
- All Participants
You may not qualify if…
- Unable to provide informed consent (or assent if under 18)
- Parents do not provide consent for participants under 18
- Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments).
- Cannot pass the CMRR safety screen for receiving an MRI
- Participant does not comply with study procedures. Exclusion is determined at PI discretion.
Where it is running
- University of Minnesota, Dept of Psychiatry — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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