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NCT Number: NCT06273527

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)

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.

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UC San Diego

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Jessica Sauceda

CONTACT

[email protected]

858.822.1470

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COGENT

Behavioral

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

Sham Program

Other

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

Primary outcomes

  1. 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

  1. Reading Span Blood Oxygen Level Dependent (BOLD) Response

    Time frame: Baseline, Week 4

    Functional Magnetic Resonance Imaging (fMRI) Reading span working memory capacity task while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation.

  2. Neuropsychological Performance

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

    Change from baseline in neuropsychological performance as measured by a composite of the following tests Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, Oral Reading Recognition Test, Dimensional Change Card Sort Test, Pattern Comparison Processing Speed Test, Picture Vocabulary Test (measured at baseline and week 4) and Matrix Reasoning, Digit Span, Trail Making Test, Digit Symbol Matching.

  3. Repetitive Negative Thinking (RNT)

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

    Change from baseline in RNT as measured by a composite of the Ruminative Response Scale (RRS), Penn State Worry Questionnaire (PSWQ), the Repetitive Negative Thinking Questionnaire-10 (RTQ-10) and the Perseverative Thinking Questionnaire (PTQ).

    The total score for the RRS ranges from 22 to 88, with higher scores indicating higher degrees of ruminative symptoms.

    The total score for the PSWQ ranges from 16 to 80, with higher scores indicating higher worry.

    The total score for the RTQ-10 ranges from 10 to 50, with higher scores indicating higher repetitive thinking.

    The total score for the PTQ ranges from 0 to 60, with higher scores indicating higher repetitive negative thinking. Scores of each characteristic of RNT can also be obtained.

Other outcomes

  1. Disability

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

    Change from baseline in disability across six domains, understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).

    A simple score for the WHODAS 2.0 ranges from 36-180 with higher scores indicating the degree of functional limitations. An item-response-theory based score can also be obtained by summing the recoded item scores within each of the six domains, summing the domains, and converting the summary score into a metric ranging from 0 to 100, with higher scores indicating higher disability.

  2. Suicide Cognitions

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

    Change from baseline in suicide-related beliefs as measures by the Suicide Cognitions Scale-Revised (SCS-R). The total score ranges from 0 to 64, with higher scores indicating higher severity of suicidal cognitions.

  3. Mood and Emotions

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

    Changes from baseline in mood and emotions as measured by the Positive and Negative Affect Schedule (PANAS).There are two scores calculated, one for positive affect and one for negative affect. The total score for positive affect ranges from 10 to 50. The total score for negative affect ranges from 11 to 55.

  4. Self-reported attention

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

    Change from baseline in attention focusing and attention shifting as measured by the Attention Control Questionnaire. The total score ranges from 20 to 80, with higher scores indicating higher levels of attention control.

  5. Anxiety Symptoms

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

    Change from baseline in anxiety symptoms as measured by General Anxiety Disorder 7 (GAD-7). The total score ranges from 0-21. With higher scores indicating higher levels of anxiety symptoms.

  6. Symptoms of Depression

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

    Change from baseline in symptoms of depression as measured by the PhenX Depression-Quick Inventory of Depressive Symptoms (QUIDS). The total score ranges from 0-27, with higher scores indicating higher depressive symptoms.

  7. PTSD Symptoms

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

    Change from baseline in PTSD symptoms as measured by PTSD Checklist for DSM-5 (PCL-5).The total score ranges from 0-80, with higher scores indicating higher severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Bomyea, Ph.D.

CONTACT

[email protected]

858.552.8585 ext. 1416

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2024
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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