Back to resultsSocial Support and Reduced Fear Acquisition
Primary Purpose
Fear, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social support image
Sponsored by
About this trial
This is an interventional basic science trial for Fear focused on measuring social support, fear acquisition
Eligibility Criteria
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
Sites / Locations
- UCLA Department of PsychologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Social Support
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04564976
First Posted
September 10, 2020
Last Updated
September 20, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04564976
Brief Title
Social Support and Reduced Fear Acquisition
Official Title
Can Social Support Figures Enhance Fear Extinction in Patients With Social Anxiety?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear, Anxiety
Keywords
social support, fear acquisition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social Support
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Social support image
Intervention Description
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).
Primary Outcome Measure Information:
Title
Fear response during acquisition indicated by elevated Galvanic Skin Response (GSR)
Description
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).
Time Frame
during acquisition procedure
Title
Fear response post-acquisition indicated by elevated GSR
Description
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).
Time Frame
same session - directly post-acquisition (approximately 5 minutes post procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Hornstein, PhD
Phone
9175664470
Email
ericahornstein@ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Eisenberger, PhD
Facility Information:
Facility Name
UCLA Department of Psychology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1563
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Social Support and Reduced Fear Acquisition
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