Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Depression Posttraumatic Stress Disorder Behavioral: COGENT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cognitive Training Low Dose
Cognitive training completed for 8 sessions
Behavioral: COGENT
COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.

Experimental: Cognitive Training High Dose
Cognitive training completed for 16 sessions
Behavioral: COGENT
COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.

No Intervention: Repeat Assessment



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04912089


Contacts
Layout table for location contacts
Contact: Jessica Bomyea, Ph.D. 858.552.8585 ext 1416 jbomyea@health.ucsd.edu

Sponsors and Collaborators
University of California, San Diego
Layout table for additonal information
Responsible Party: Jessica Bomyea, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04912089    
Other Study ID Numbers: 210686
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders