Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)

NCT ID: NCT06273527

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-08-01

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.

Conditions

Anxiety Disorders; Depression; Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

COGENT - Cognitive Training Intervention Program

Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources

Group Type: EXPERIMENTAL

COGENT

Intervention Type: BEHAVIORAL

COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.

Non-Training Program

The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials.

Group Type: SHAM_COMPARATOR

Sham Program

Intervention Type: OTHER

The Sham Program will be a similar task which researchers think will be less effective in training thinking skills.

Interventions

COGENT

COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.

Intervention Type: BEHAVIORAL

Sham Program

The Sham Program will be a similar task which researchers think will be less effective in training thinking skills.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jessica Bomyea

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Bomyea, Ph.D.

Role: CONTACT

jbomyea@health.ucsd.edu

858.552.8585 ext. 1416

Facility Contacts

Jessica Sauceda

Role: primary

UCSDanxietylab@health.ucsd.edu

858.822.1470

Other Identifiers

808681

Identifier Type: -

Identifier Source: org_study_id