Investigating the Effects of Social Stress on Brain Imaging

Social Stress Clinical Trial

— SSBI  

Official title:

Investigating the Effects of Social Stress on Brain Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05591404
• Other study ID #: 2206000689
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Massachusetts Institute of Technology
• Contact: Omar Rutledge, MS
• Phone: 617-324-2898
• Email: orutledge[@]mit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether experiencing a social stressor prior to the collection of neuroimaging measures is associated with differences in brain activation in healthy participants.

Description:

Using a randomized, parallel-group study design, this scientific investigation will examine the effect that experiencing the Trier Social Stress Test (TSST), the gold-standard for ethically inducing stress in a controlled laboratory setting, may have on neuroimaging measures of anxiety in healthy subjects. The study will enroll 50 healthy subjects who will be randomized to either experience the TSST or watch a nature film prior to undergoing task-based neuroimaging measures of emotional processing and self-referential processing using functional magnetic resonance imaging (fMRI). This study will be conducted primarily at Massachusetts Institute of Technology with research and clinical support from Massachusetts General Hospital.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Ability and willingness to provide written informed consent.
• Sufficiently fluent in English to participate in the trial.
• Between 18-55 years of age (inclusive).
• Right-hand dominant.
• Current medications are stable for past 30 days (no changes to dose or frequency).
• Negative result on pregnancy test (if female).
• Negative result on urine drug screening.
• No clinically significant mental health disorders (QuickSCID-5).
• Liebowitz Social Anxiety Scale (LSAS <30).

Exclusion Criteria:

• History of bipolar disorder, schizophrenia, psychosis, delusional disorders.
• History of eating disorder within past 6 months.
• History of any traumatic brain injury.
• Currently diagnosed with diabetes mellitus.
• Presence of severe medical illness that would prevent completion of study procedures.
• Presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia).
• History of substance use disorder within past 6 months (other than nicotine and caffeine).
• Use of any cannabis-containing products in past 30 days (CBD or THC).
• Use of beta-blockers or benzodiazepines in past 2 weeks.
• History of claustrophobia.
• Contraindications for MRI (e.g.; shrapnel).
• Presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures.

Related Conditions & MeSH terms

• Social Stress

Intervention

Behavioral:
• Trier Social Stress Test (TSST)
Participants randomized to the TSST arm will experience the Trier Social Stress Test.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Massachusetts Institute of Technology	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts Institute of Technology	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in fMRI BOLD Response	Patterns of brain activation measured as blood-oxygenation-level dependent (BOLD) signals will be assessed using 3.0 Tesla (3T) functional magnetic resonance imaging (fMRI). Several exploratory imaging paradigms, including the emotional face-matching task (EFMT) and the self-referential comment task (SRCT), will be used to examine differences between participants who experience the TSST and those who do not.	Day 1