Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

NCT ID: NCT04912089

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Anxiety Disorders; Depression; Posttraumatic Stress Disorder

Study Design

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

Study Groups

Cognitive Training Low Dose

Cognitive training completed for 8 sessions

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.

Cognitive Training High Dose

Cognitive training completed for 16 sessions

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.

Repeat Assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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)
• 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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

210686

Identifier Type: -

Identifier Source: org_study_id