Is Cognitive Training Neuroprotective in Early Psychosis?



Status:Recruiting
Conditions:Healthy Studies, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 35
Updated:3/22/2019
Start Date:June 12, 2017
End Date:June 12, 2021
Contact:Riley Capizzi
Email:minicotes@umn.edu
Phone:612-626-5167

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The purpose of this study is to perform longitudinal high-resolution 7T 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.

This study will seek to enroll 60 participants. 40 participants will be considered First
Episode Psychosis (FEP) patients, meaning that they have been diagnosed with a psychotic
illness with their first psychotic episode occurring within the last two years at time of
enrollment. These participants will be recruited from a separate study protocol conducted by
Dr. Sophia Vinogradov which examines remote cognitive training in FEP subjects (application
in progress). 20 of these participants will receive treatment as usual (TAU), while 20 will
be assigned to Targeted Cognitive Training (TCT). Additionally, the investigators will enroll
20 healthy, age and gender matched controls (HC). All participants will undergo 2 MRI scans
approximately one year apart. Each MRI scan should last about one hour. The outcome
measurements of this study will be changes in functional, structural, and diffusion weight
images over time within subjects and between groups.

First Episode Psychosis (FEP) Participants

Inclusion Criteria:

- Enrolled in the Mini-COTES randomized controlled trial examining cognitive training in
First Episode Psychosis

- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform
disorder, psychotic disorder not otherwise specified, or unspecified schizophrenia
spectrum disorder, with onset of first psychotic episode within the last 2 years.

- Good general physical health

- Age between 18 and 35 (inclusive)

- Fluent in English

- No substance dependence in the past 6 months determined by DSM-IV criteria

- Achieved clinical stability, defined as outpatient status for at least 1 month prior
to study participation plus stable doses of psychiatric medications for at least one
month prior to study participation.

Exclusion Criteria:

- Unable to provide informed consent

- Cannot pass the CMRR safety screen for receiving an MRI

Healthy Controls (HC) Participants

Inclusion Criteria:

- Age between 18 and 35 (inclusive)

- Fluent in English

- Good general physical health

- No neurological disorder

- No substance dependence in the past 6 months determined by DSM-IV criteria

- No current or past diagnosis of a psychotic disorder, mood disorder, or anxiety
disorder

Exclusion Criteria:

- Unable to provide informed consent

- Cannot pass the CMRR safety screen for receiving an MRI
We found this trial at
1
site
Minneapolis, Minnesota 55454
Phone: 612-625-7886
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Minneapolis, MN
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