AnxietyNCT07805070
Uncovering Neurocognitive Mechanisms and Enhancement of Exposure-based Fear Learning With Cognitive Training
A study testing Cognitive training in people with Anxiety and Fear Extinction, run by University of California, San Diego.
Trial summary
Anxiety disorders remain are among the most prevalent psychiatric conditions and are associated with negative outcomes spanning poor health to increased suicide risk. While exposure therapy is recognized as a gold standard empirically supported treatment, many individuals fail to achieve adequate response. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Fear Extinction
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Sep 2031
- Phase
- Interventional
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65
- fluent in English
- diagnosis of social anxiety disorder (generalized or performance-only) with Personal Report of Public Speaking Anxiety (PRPSA) score of ≥120 at screening
- 6-week stability if receiving other (non-anxiety focused) psychosocial treatment
Who cannot join
- past 3-mo diagnosis of moderate or greater alcohol or substance use disorder
- lifetime history of psychotic or bipolar I disorders
- acute suicidality necessitating immediate clinical intervention
- neurodegenerative or neurodevelopmental disorders
- history of neurological condition
- conditions that are unsafe for MRI (e.g., metal in body)
- currently receiving psychosocial treatment for anxiety or related condition
- currently receiving psychiatric pharmacotherapy
About this study
Anxiety disorders remain are among the most prevalent psychiatric conditions and are associated with negative outcomes spanning poor health to increased suicide risk. While exposure therapy is recognized as a gold standard empirically supported treatment, many individuals fail to achieve adequate response. Exposure therapy is grounded in fear extinction learning models, which suggest that anxiety diminishes when individuals repeatedly confront their fears. To improve exposure-based interventions, it is critical to enhance our understanding of underlying mechanisms of fear extinction and how to better target these mechanisms. Fear extinction requires basic neurocognitive abilities that allow individuals to learn from and adapt to experiences confronting feared situations. Emerging cross sectional and experimental data suggest that working memory is a particularly important neurocognitive process that is associated with fear learning outcomes. By enhancing working memory through experimental manipulations like cognitive training, we may improve the fear extinction learning processes essential for successful exposure therapy. Unlike other neurocognitive enhancements (e.g., medications), computer-based working memory training offers high mechanistic precision, ease of administration, and low cost. The long-term goal of this research is to develop a novel mechanistic understanding of the neurocognitive processes involved in exposure-based fear extinction learning, ultimately aiming to improve interventions for anxiety disorders. This study will test the effects of manipulating working memory prior to a massed exposure paradigm, comparing working memory training plus massed exposure (WMT+Ex) to a sham training plus massed exposure (ST+Ex) condition. Using public speaking anxiety as a clinical exemplar, we will employ a rigorous experimental trial design combined with a validated single-visit speech exposure paradigm to assess fear extinction learning outcomes through multiple measures, including behavioral, physiological, neural, and self-report. The central hypothesis is that WMT+Ex will improve markers of fear extinction learning considered to underlie clinical response in exposure therapy. Specific aims are to 1) determine the extent to which working memory training delivered prior to massed exposure improves behavioral and neural markers of fear extinction learning, and 2) evaluate the effects of working memory training delivered prior to massed exposure on fear extinction learning occurring during exposure. This study is expected to achieve two goals: first, to advance our understanding of the neurocognitive mechanisms of fear extinction through a rigorous experimental design, and second, to validate a combined working memory training and exposure paradigm. If successful in enhancing fear extinction, this approach could be further explored in therapeutic formats to assess its clinical effects.
- Conditions
- Anxiety, Fear Extinction
- Being tested
- Cognitive training
- Keywords
- anxiety, social phobia
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Repeated practice with cognitive skills to enhance performance
Cognitive trainingBehavioural
Sham cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Active comparator | Training to enhance cognitive functioning Receives: Behavioral: Cognitive training |
| Sham training | Sham comparator | Computer interface designed to control for general task parameters Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear extinction
threat expectancy ratings to the CS+ during late extinction learning
Measured: Change from baseline day 1 to post-intervention day 2
Subjective Units of Distress
Ratings of distress during speeches
Measured: Change from baseline speech to post speech (all within day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT07805070
- Sponsor's protocol ID
- 812820
- Other IDs
- 1R01MH141088-01A1
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIH NDA