Cognitive Training for Emotion Regulation in Psychotic Disorders

Sponsor
University of Georgia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04414215
Collaborator
(none)
70
1
2
68
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotional working memory training
  • Behavioral: Placebo working memory training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory trainingA double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory training
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Cognitive Training for Emotion Regulation in Psychotic Disorders
Anticipated Study Start Date :
Oct 15, 2020
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jun 15, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive training

Emotional working memory training

Behavioral: 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

Behavioral: Placebo working memory training
Working memory training that does not involve emotional stimuli using an N-back training program

Outcome Measures

Primary Outcome Measures

  1. Prefrontal blood oxygen level dependent activation in the prefrontal cortex [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

    1. endorsement of MRI exclusion factors

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Georgia Athens Georgia United States 30602

Sponsors and Collaborators

  • University of Georgia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gregory Paul Strauss, Assistant Professor, University of Georgia
ClinicalTrials.gov Identifier:
NCT04414215
Other Study ID Numbers:
  • 00001377
First Posted:
Jun 4, 2020
Last Update Posted:
Aug 24, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2020