Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)

NCT06273527 | Recruiting Phase 2

• 1 other identifier: 808681
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in cognitive performance

  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.

  Baseline, Week 4, Week 8, Week 16

Secondary Outcomes (3)

• 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

Other Outcomes (7)

• Disability

  Baseline, Week 4,Week 8, Week 16

• Suicide Cognitions

  Baseline, Week 4,Week 8, Week 16

• Mood and Emotions

  Baseline, Week 4,Week 8, Week 16

Study Arms (2)

COGENT - Cognitive Training Intervention Program

EXPERIMENTAL

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

Behavioral: COGENT

Non-Training Program

SHAM COMPARATOR

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.

Other: Sham Program

Interventions

COGENT BEHAVIORAL

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

COGENT - Cognitive Training Intervention Program

Sham Program OTHER

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

Non-Training Program

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

San Diego, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Interventions

cogent db

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Jessica Bomyea, Ph.D.

CONTACT

858.552.8585; jbomyea@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 22, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)