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Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

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ClinicalTrials.gov Identifier: NCT04912089
Recruitment Status : Not yet recruiting
First Posted : June 3, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Jessica Bomyea, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE May 28, 2021
First Posted Date  ICMJE June 3, 2021
Last Update Posted Date June 7, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2021)
Change in cognitive performance [ Time Frame: Baseline, Week 4 ]
Operation Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2021)
  • Reading Span Blood Oxygen Level Dependent (BOLD) Response [ Time Frame: Baseline, Week 4 ]
    Functional Magnetic Resonance Imaging (fMRI) Reading span working memory capacity task while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation.
  • Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response [ Time Frame: Week 4 ]
    Functional Magnetic Resonance Imaging (fMRI) emotional working memory capacity task while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Official Title  ICMJE Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
Brief Summary The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to a high dose, low dose, or assessment only condition. Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.
Detailed Description Mood, anxiety, and traumatic stress disorders are common psychiatric conditions - affecting over 40 million U.S. adults - and are leading causes of disability worldwide. People with these conditions are commonly plagued by difficulty controlling distressing personal thoughts and memories, collectively referred to as repetitive negative thinking symptoms. Models suggest that repetitive negative thinking is driven by executive functioning deficits, such that cognitive resources are insufficient to downregulate unwanted thoughts. Executive functioning deficits could be a promising treatment target but are not typically addressed with existing interventions. The long-term goal advanced by this project is to develop effective, mechanistic cognitive training programs that can improve cognition and reduce symptoms associated with mood, anxiety, and traumatic stress disorders. The objectives of this proposal are first to determine the optimal dose of a cognitive training program designed to improve executive functioning in this population using behavioral and neural outcomes. The central hypothesis is that repeated training exercises will enhance executive functioning and will lead to a reduction of repetitive negative thinking in mood, anxiety, and traumatic stress disorders. The project will randomize participants with depression, anxiety, and/or traumatic stress disorders to one of two doses of cognitive training or a no-treatment control condition. The investigators will examine executive functioning change with cognitive task performance and functional neuroimaging assessments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • Depression
  • Posttraumatic Stress Disorder
Intervention  ICMJE Behavioral: COGENT
COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
Study Arms  ICMJE
  • Experimental: Cognitive Training Low Dose
    Cognitive training completed for 8 sessions
    Intervention: Behavioral: COGENT
  • Experimental: Cognitive Training High Dose
    Cognitive training completed for 16 sessions
    Intervention: Behavioral: COGENT
  • No Intervention: Repeat Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2021)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 21-55
  • fluent in English
  • diagnosis of mood, anxiety, or traumatic stress disorder
  • clinically elevated repetitive negative thinking
  • outpatient status
  • 6-week stability if taking selective serotonin reuptake inhibitor (SSRI) medications

Exclusion Criteria:

  • past year diagnosis of severe alcohol or moderate or greater substance use disorder
  • lifetime history of psychotic or bipolar I disorder
  • acute suicidality necessitating immediate clinical intervention
  • neurodegenerative or neurodevelopmental disorders
  • history of moderate or severe traumatic brain injury or other known neurological condition
  • sensory deficits that would preclude completing tasks
  • conditions unsafe for completing MRI scanning (e.g., metal in body)
  • currently receiving psychosocial treatment
  • currently receiving psychiatric pharmacotherapy, except SSRIs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica Bomyea, Ph.D. 858.552.8585 ext 1416 jbomyea@health.ucsd.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04912089
Other Study ID Numbers  ICMJE 210686
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jessica Bomyea, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP