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CompletedNCT04953832Updated Oct 1, 2021

Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

An interventional study of Cognitive Training in Anxiety Disorders, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-10-01.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Nov 2019, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

Anxiety disorders are highly prevalent and costly to the individual and society. Exposure-based cognitive behavioral therapy (CBT) is the gold-standard intervention for anxiety disorders, although this approach does not fully reduce symptoms for all individuals. Therefore there is a need for innovative intervention approaches. One approach to augment and improve existing therapies would be to enhance the neurocognitive basis of fear extinction processes, which are the model on which treatments are based. Enhancing these processes may be possible through computerized cognitive training techniques which target executive functioning, the cognitive processes that help people manage complex cognitive activities. The proposed project is a proof-of-concept pilot study investigating the potential for training of executive functioning to improve anxiety-related outcomes. Individuals with elevated levels of social anxiety will be randomized to single-session COGnitive Enhancement Training (COGENT) or sham training program (ST). All participants will complete a single speech session where they present three 7-minute impromptu speeches and rate their anxiety at specific intervals. Participants will then complete the COGENT paradigm and affective processing task while undergoing fMRI.

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Conditions studied

  • Anxiety Disorders

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Screened positive for anxiety symptoms
  2. Between the ages of 18-55, inclusive.
  3. Have signed informed consent document(s) indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study.
  4. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Evidence of psychosis, bipolar disorder, or severe substance use disorder based on clinical cutoffs on self report measures
  2. Current neurological conditions based on brief medical history
  3. Current psychotherapy for anxiety or psychotropic medications
  4. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body piercings, and pregnancy.
  5. Active suicidal ideation endorsed on the depression self-report measure.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Cognitive Training + exposure

    Participants will complete adaptive computerized cognitive training plus a series of speech tasks

    Behavioral: Cognitive Training

  • Active comparator
    No training + exposure

    Participants will complete a low-dose computerized cognitive program plus a series of speech tasks

    Behavioral: Cognitive Training

Interventions

  • BehavioralCognitive Training

    Participants are asked to remember a series of items while solving puzzles.

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What researchers measure

Primary outcomes

  1. BOLD activation during cognitive task

    Working Memory Span task during fMRI

    Time frame: immediately after the intervention

  2. BOLD activation during emotional task

    Face processing task during fMRI

    Time frame: immediately after the intervention

Secondary outcomes

  1. Speech anxiety ratings

    Subjective units of distress, scaled from 0 to 100, during each of 3, 7-minute speech activities

    Time frame: baseline, ratings during 3 speeches

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Study locations

1 site
  • UC San Diego
    San Diego, California 92037, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04953832
Lead sponsor
University of California, San Diego
Responsible party
Jessica Bomyea (Assistant Professor, University of California, San Diego) — Principal investigator
First posted
Jul 8, 2021
Start date
Nov 1, 2019
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Oct 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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