Cognitive Training for Emotion Regulation in Psychotic Disorders
Primary Purpose
Schizophrenia, Schizo Affective Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional working memory training
Placebo working memory training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- University of GeorgiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cognitive training
Placebo training
Arm Description
Emotional working memory training
Placebo working memory training
Outcomes
Primary Outcome Measures
Prefrontal blood oxygen level dependent activation in the prefrontal cortex
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04414215
Brief Title
Cognitive Training for Emotion Regulation in Psychotic Disorders
Official Title
Cognitive Training for Emotion Regulation in Psychotic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory training
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive training
Arm Type
Experimental
Arm Description
Emotional working memory training
Arm Title
Placebo training
Arm Type
Placebo Comparator
Arm Description
Placebo working memory training
Intervention Type
Behavioral
Intervention Name(s)
Emotional working memory training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Placebo working memory training
Intervention Description
Working memory training that does not involve emotional stimuli using an N-back training program
Primary Outcome Measure Information:
Title
Prefrontal blood oxygen level dependent activation in the prefrontal cortex
Description
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
Time Frame
Change from baseline to 15 days or 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory P Strauss, PhD
Phone
706-542-0307
Email
gstrauss@uga.edu
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory P Strauss, PhD
Phone
706-542-0307
Email
gstrauss@uga.edu
First Name & Middle Initial & Last Name & Degree
Gregory P Strauss, PhD
First Name & Middle Initial & Last Name & Degree
Lawrence Sweet, PhD
First Name & Middle Initial & Last Name & Degree
Dean Sabatinelli, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Cognitive Training for Emotion Regulation in Psychotic Disorders
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