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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04564976
Other study ID # SSA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 9, 2022
Est. completion date December 2024

Study information

Verified date September 2023
Source University of California, Los Angeles
Contact Erica Hornstein, PhD
Phone 9175664470
Email ericahornstein@ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

University of California, Los Angeles researchers will recruit healthy participants and anxious participants (those diagnosed with social anxiety disorder) age 18-55 years old to participate in a study examining whether the ability of social support figure reminders to prevent the acquisition of fear in healthy participants extends to those with anxiety disorders. After being recruited from the UCLA community (healthy participants, n = 50) or referred by treatment providers at the Anxiety and Depression Research Center at UCLA (anxious participants, n =50) and undergoing a telephone screening and in-person screening, 100 participants will be enrolled in the study. During the experiment, all participants will undergo the same procedures: undergoing fear acquisition procedures--the repeated pairing of a neutral image with a mild electric shock that ultimately leads to the association of threat of shock with the image--in the presence of an image of a social support figure (provided by participants) and an image of a smiling stranger.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - healthy adults 18 and 35 - fluent in English - no history of mental illness (healthy participants: including anxiety, depression, phobia, or any other mental health related disorder diagnosed by a mental health professional) - diagnosis of social anxiety disorder (anxious participants: allowed co-morbid disorders include depression, other anxiety disorders, and PTSD) Exclusion Criteria: - pregnant or planning to become pregnant during the experiment period - presence of chronic mental illness (healthy participants: as determined by the report of a past diagnosis of mental illness by a physician or psychologist and/or the prescription of medication related to mental health disorder; including anxiety, depression, phobia, or any other diagnosed psychological disorder) - presence of non-allowed co-morbid disorders (anxious participants: including, bipolar disorder, psychosis, substance use disorder, neurological disorder, and/or obsessive-compulsive disorder) - current and regular use of prescription medications related to mental health disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social support image
An image of a social support figure specific to each participant (provided by the participant) will be present while participants undergo a fear acquisition procedure. Specifically--the image will be presented alongside a neutral image that is either consistently paired with shock (CS+) or never paired with shock (CS-), so that assessment of whether there are differences in fear responding (evaluated via SCR) due the shock pairing can be assessed. This is a typical fear acquisition procedure, and a typical outcome would be for SCR to be higher for the CS+ compared to the CS- toward the end and following the procedure, indicating that the CS+ is now associated with the aversive shock and is bringing about a fear response (in this case indexed by increased sympathetic nervous system activity preparing the body to fight or flee).

Locations

Country Name City State
United States UCLA Department of Psychology Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fear response during acquisition indicated by elevated Galvanic Skin Response (GSR) presence of fear response as indicated by significantly higher galvanic skin response (GSR: an index of peripheral stress responding) to a previously learned fearful image (CS+) compared to a baseline comparator (CS-: never learned to be fearful). during acquisition procedure
Primary Fear response post-acquisition indicated by elevated GSR presence of fear response as indicated by significantly higher galvanic skin response (GSR: an index of peripheral stress responding) to a previously learned fearful image (CS+) compared to a baseline comparator (CS-: never learned to be fearful). same session - directly post-acquisition (approximately 5 minutes post procedure)
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