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OpenTrials
Completed

NCT Number: NCT04953832

Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

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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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

San Diego, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Screened positive for anxiety symptoms
  • Between the ages of 18-55, inclusive.
  • 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.
  • Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion criteria

  • Evidence of psychosis, bipolar disorder, or severe substance use disorder based on clinical cutoffs on self report measures
  • Current neurological conditions based on brief medical history
  • Current psychotherapy for anxiety or psychotropic medications
  • 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.
  • Active suicidal ideation endorsed on the depression self-report measure.

Treatment and study plan

Cognitive training

Behavioral

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

Primary outcomes

  1. BOLD activation during cognitive task

    Time frame: immediately after the intervention

    Working Memory Span task during fMRI

  2. BOLD activation during emotional task

    Time frame: immediately after the intervention

    Face processing task during fMRI

Secondary outcomes

  1. Speech anxiety ratings

    Time frame: baseline, ratings during 3 speeches

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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Oct 1, 2021

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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