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Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)

NCT06273527 · University of California, San Diego
In plain English

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Official title
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
About this study
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.
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
Study design
Enrollment target: 128 participants
Allocation: randomized
Masking: double
Age groups: adult
Timeline
Starts: 2024-10-01
Estimated completion: 2027-08-01
Last updated: 2025-10-24
Interventions
Behavioral: COGENTOther: Sham Program
Primary outcomes
  • Change in cognitive performance (Baseline, Week 4, Week 8, Week 16)
Sponsor
University of California, San Diego · other
Contacts & investigators
ContactJessica Bomyea, Ph.D. · contact · jbomyea@health.ucsd.edu · 858.552.8585
All locations (1)
UC San DiegoRecruiting
San Diego, California, United States
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33) · TrialPath