Anxiety DisordersNCT04912089
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
A study testing COGENT in people with Anxiety Disorders and Depression, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Anxiety Disorders, Depression, Posttraumatic Stress Disorder
- What is being tested?
- COGENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- conditions unsafe for completing MRI scanning (e.g., metal in body)
- currently receiving psychosocial treatment
- currently receiving psychiatric pharmacotherapy, except SSRIs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
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.
Read the 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
- Being tested
- COGENT
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGENTBehavioural
COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training Low Dose | Experimental | Cognitive training completed for 8 sessions Receives: Behavioral: COGENT |
| Cognitive Training High Dose | Experimental | Cognitive training completed for 16 sessions Receives: Behavioral: COGENT |
| Repeat Assessment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (0-81 range).
Measured: Baseline, Week 4
Secondary outcomes (16)
Change in Reading Span Blood Oxygen Level Dependent (BOLD) Response
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.
Measured: Baseline, Week 4
Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response
Functional Magnetic Resonance Imaging (fMRI) emotional 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.
Measured: Week 4
Change in Neuropsychological Performance
Change from baseline in neuropsychological performance as measured by 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, Matrix Reasoning, Digit Span, Trail Making Test, Digit Symbol Matching, composite score (change in NIH corrected fluid cognition t score) with larger scores reflecting larger gains (1-100 range; T score of 50 is mean with standard deviation of 10).
Measured: Baseline, Week 4
Anxiety Symptoms
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.
Measured: Baseline, Week 4
Symptoms of Depression
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.
Measured: Baseline, Week 4
PTSD Symptoms
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.
Measured: Baseline, Week 4
Change Repetitive Negative Thinking (RNT)
Change from baseline in RNT as measured by the Ruminative Response Scale (RRS), Penn State Worry Questionnaire (PSWQ), the Repetitive Negative Thinking Questionnaire-10 (RTQ-10) and the Perseverative Thinking Questionnaire (PTQ) composite z score (z score of 0 reflects mean, larger scores reflecting worse symptoms).
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.
Measured: Baseline, Week 4
Self-reported Attention Attention
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.
Measured: Baseline, Week 4
Emotion Regulation
Change from baseline in emotion regulation tendencies as measured by the Emotion Regulation Questionnaire (ERQ). Scores are obtained by averaging the scores of two subscales: cognitive reappraisal and expressive suppression. Higher scores indicating higher use of emotion regulation (10 to 70 range).
Measured: Baseline, Week 4
Disability
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.
Measured: Baseline, Week 4
Suicide Cognitions
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.
Measured: Baseline, Week 4
Alcohol Use
Change from baseline in drinking patterns as measured by the Alcohol Use Disorders Identification Test (AUDIT). The total score ranges from 0 to 40, with higher scores indicating higher risk. Such that 1-7 indicates low risk, 8-12 risky, and 13+ high risk.
Measured: Baseline, Week 4
Drug Abuse
Change from baseline in drug abuse as measured by the Drug Abuse Screening Test (DAST-10). The total score ranges from 0-10, with higher scores indicating higher degree of drug abuse related problems.
Measured: Baseline, Week 4
Insomnia
Changes from baseline in insomnia problems as measured by the Insomnia Severity Index (ISI). The total score ranges 0-21, with higher scores indicating severity of insomnia.
Measured: Baseline, Week 4
Change in Mood and Emotions: Negative Affect
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 (higher is greater emotion on the dimension).
Measured: Baseline, Week 4
Change in Mood and Emotion: Positive Affect
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 (higher is greater emotion on the dimension).
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Oct 2021
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Bomyea, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912089
- Sponsor's protocol ID
- 210686
- Status last verified
- Jul 2025
- First submitted
- 28 May 2021
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
- ClinicalTrials.gov ID
- NCT04912089
- Acronym / sponsor ID
- 210686
- Conditions
- Anxiety Disorders, Depression, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training Low Dose | Experimental | Behavioral: COGENTCognitive training completed for 8 sessions |
| Cognitive Training High Dose | Experimental | Behavioral: COGENTCognitive training completed for 16 sessions |
| Repeat Assessment | No intervention | – |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age 21-55
- fluent in English
- diagnosis of mood, anxiety, or traumatic stress disorder
- clinically elevated repetitive negative thinking
- outpatient status
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COGENTCOGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task. | Behavioural | Cognitive Training High Dose, Cognitive Training Low Dose |
Primary outcome
Change in Cognitive Performance
Time frame: Baseline, Week 4
Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance (0-81 range).
16 secondary outcomes
Change in Reading Span Blood Oxygen Level Dependent (BOLD) Response
Time frame: Baseline, Week 4
Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response
Time frame: Week 4
Change in Neuropsychological Performance
Time frame: Baseline, Week 4
Anxiety Symptoms
Time frame: Baseline, Week 4
Symptoms of Depression
Time frame: Baseline, Week 4
PTSD Symptoms
Time frame: Baseline, Week 4
Change Repetitive Negative Thinking (RNT)
Time frame: Baseline, Week 4
Self-reported Attention Attention
Time frame: Baseline, Week 4
Emotion Regulation
Time frame: Baseline, Week 4
Disability
Time frame: Baseline, Week 4
Suicide Cognitions
Time frame: Baseline, Week 4
Alcohol Use
Time frame: Baseline, Week 4
Drug Abuse
Time frame: Baseline, Week 4
Insomnia
Time frame: Baseline, Week 4
Change in Mood and Emotions: Negative Affect
Time frame: Baseline, Week 4
Change in Mood and Emotion: Positive Affect
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COGENT in people with Anxiety Disorders and Depression, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Performance (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.