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Clinical Trials/NCT06273527
NCT06273527
Recruiting
Phase 2

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

University of California, San Diego1 site in 1 country128 target enrollmentOctober 1, 2024

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
University of California, San Diego
Enrollment
128
Locations
1
Primary Endpoint
Change in cognitive performance
Status
Recruiting
Last Updated
6 months ago

Overview

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 one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham 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 is to evaluate the cognitive effects of the optimized computer-based cognitive training intervention relative to a sham training program (ST). The central hypothesis is that the cognitive training intervention 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 a cognitive training intervention program or a sham training program. The investigators will examine executive functioning change with cognitive task performance and functional neuroimaging assessments.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
August 1, 2027
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Bomyea

Assistant Professor

University of California, San Diego

Eligibility 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)
  • current pregnancy
  • currently receiving psychosocial treatment
  • currently receiving psychiatric pharmacotherapy, except SSRIs

Outcomes

Primary Outcomes

Change in cognitive performance

Time Frame: Baseline, Week 4, Week 8, Week 16

Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance. This change is expected to be significantly higher for the COGENT group than the Sham group.

Secondary Outcomes

  • Reading Span Blood Oxygen Level Dependent (BOLD) Response(Baseline, Week 4)
  • Neuropsychological Performance(Baseline, Week 4, Week 8, Week 16)
  • Repetitive Negative Thinking (RNT)(Baseline, Week 4,Week 8, Week 16)

Study Sites (1)

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