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Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04953832
Enrollment
30
Registered
2021-07-08
Start date
2019-11-01
Completion date
2021-09-01
Last updated
2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Brief 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.

Interventions

BEHAVIORALCognitive Training

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

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
BOLD activation during cognitive taskimmediately after the interventionWorking Memory Span task during fMRI
BOLD activation during emotional taskimmediately after the interventionFace processing task during fMRI

Secondary

MeasureTime frameDescription
Speech anxiety ratingsbaseline, ratings during 3 speechesSubjective units of distress, scaled from 0 to 100, during each of 3, 7-minute speech activities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026