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

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:
        • 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.

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

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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