- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414215
Cognitive Training for Emotion Regulation in Psychotic Disorders
February 13, 2023 updated by: Gregory Paul Strauss, University of Georgia
The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders.
it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and present major challenges to our health care system.
Difficulties with emotion regulation (i.e., the ability to control the emotion response using strategies) significantly predict the development and maintenance of psychotic symptoms and poor community-based functional outcomes.
Recent neuroimaging research indicates that hypofrontality may underlie these deficits.
Unfortunately, there is no accepted technique for remediating these emotion regulation abnormalities in psychotic disorders.
Recent advances from the field of cognitive neuroscience provide hope for a resolution to this critical unmet need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive training interventions are capable of improving emotion regulation ability by targeting neural activation in the prefrontal cortex.
The goal of the proposed project is to determine whether an emotional working memory cognitive training program is effective for remediating emotion regulation abnormalities and associated clinical outcomes in people with psychotic disorders.
Outpatients with psychotic disorders will be randomly assigned to either an emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control intervention delivered via an app on a smart phone for 30 days.
The primary aim is to determine whether the emotional working memory intervention successfully engages the target mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer task beyond a pre-specified effect size criterion.
Results will also be used to determine the treatment duration (15 vs. 30 days) that most effectively and efficiently improves the target.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gregory P Strauss, PhD
- Phone Number: 706-542-0307
- Email: gstrauss@uga.edu
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- Recruiting
- University of Georgia
-
Contact:
- Gregory P Strauss, PhD
- Phone Number: 706-542-0307
- Email: gstrauss@uga.edu
-
Principal Investigator:
- Gregory P Strauss, PhD
-
Sub-Investigator:
- Lawrence Sweet, PhD
-
Sub-Investigator:
- Dean Sabatinelli, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder
- 18-60 years old
- speaks English
- premorbid intelligence quotient > 70
- clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.
Exclusion Criteria:
- history of intellectual disability or neurological disorder
- history of traumatic brain injury with loss of consciousness > 10 minutes or behavioral sequelae
- substance use disorder within the last 6 months (other than nicotine)
- 4) endorsement of MRI exclusion factors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive training
Emotional working memory training
|
Participants will complete an emotional working memory n-back training program that progressively increases difficulty and has been shown to enhance prefrontal activity in a non-psychiatric sample
|
Placebo Comparator: Placebo training
Placebo working memory training
|
Working memory training that does not involve emotional stimuli using an N-back training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prefrontal blood oxygen level dependent activation in the prefrontal cortex
Time Frame: Change from baseline to 15 days or 30 days
|
blood oxygen level dependent change in the prefrontal cortex as measured using functional magnetic resonance imaging.
This will be calculated as a change from baseline to follow-up on the contrast score (unpleasant passive viewing condition - reappraisal) on the emotion regulation reappraisal task
|
Change from baseline to 15 days or 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
May 29, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Estimate)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001377
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be uploaded to the National Institute of Mental Health Data Archive
IPD Sharing Time Frame
1 year after study completion for 1 year
IPD Sharing Access Criteria
The National Institute of Mental Health Data Archive request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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