Anxiety DisordersPhase 2/3NCT06273527
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)
A Phase 2/3 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 one of two groups. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Anxiety Disorders, Depression, Post Traumatic Stress Disorder
- What is being tested?
- COGENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 10Show fewer
- conditions unsafe for completing MRI scanning (e.g., metal in body)
- current pregnancy
- currently receiving psychosocial treatment
- currently receiving psychiatric pharmacotherapy, except SSRIs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC San Diego
San Diego, California, 92037
Jessica Sauceda, 858.822.1470, UCSDanxietylab@health.ucsd.edu
About this study
Official title: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
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.
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 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.
- Being tested
- COGENT, Sham Program
- 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.
Sham ProgramOther
The Sham Program will be a similar task which researchers think will be less effective in training thinking skills.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Sham Program |
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. This change is expected to be significantly higher for the COGENT group than the Sham group.
Measured: Baseline, Week 4, Week 8, Week 16
Secondary outcomes (3)
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
Neuropsychological Performance
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.
Measured: Baseline, Week 4, Week 8, Week 16
Repetitive Negative Thinking (RNT)
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.
Measured: Baseline, Week 4,Week 8, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Oct 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
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
- NCT06273527
- Sponsor's protocol ID
- 808681
- Status last verified
- Oct 2025
- First submitted
- 31 Jan 2024
- Last updated
- 24 Oct 2025
- Results posted
- No
- 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 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
- ClinicalTrials.gov ID
- NCT06273527
- Acronym / sponsor ID
- 808681
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COGENT - Cognitive Training Intervention Program | Experimental | Behavioral: COGENTComputer-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 |
| Non-Training Program | Sham comparator | Other: Sham ProgramThe 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. |
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 (10 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 | COGENT - Cognitive Training Intervention Program |
| Sham ProgramThe Sham Program will be a similar task which researchers think will be less effective in training thinking skills. | Other | Non-Training Program |
Primary outcome
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.
3 secondary outcomes
Reading Span Blood Oxygen Level Dependent (BOLD) Response
Time frame: Baseline, Week 4
Neuropsychological Performance
Time frame: Baseline, Week 4, Week 8, Week 16
Repetitive Negative Thinking (RNT)
Time frame: Baseline, Week 4,Week 8, Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 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 10 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: looking for participants now, as of the sponsor's last update on 24 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Bomyea, Ph.D. (858.552.8585 ext. 1416, jbomyea@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance (time frame: Baseline, Week 4, Week 8, Week 16). 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 24 Oct 2025.