SSBI: Investigating the Effects of Social Stress on Brain Imaging

Sponsor
Massachusetts Institute of Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05591404
Collaborator
Massachusetts General Hospital (Other)
50
2
2
28
25
0.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trier Social Stress Test (TSST)
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigating the Effects of Social Stress on Brain Imaging
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: TSST

Nature Film + Trier Social Stress Test (TSST)

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

No Intervention: No-TSST

Nature Film Only

Outcome Measures

Primary Outcome Measures

  1. Differences in fMRI BOLD Response [Day 1]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 Massachusetts Institute of Technology Cambridge Massachusetts United States 02139

Sponsors and Collaborators

  • Massachusetts Institute of Technology
  • Massachusetts General Hospital

Investigators

  • Principal Investigator: John D.E. Gabrieli, PhD, Massachusetts Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Massachusetts Institute of Technology
ClinicalTrials.gov Identifier:
NCT05591404
Other Study ID Numbers:
  • 2206000689
First Posted:
Oct 24, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Massachusetts Institute of Technology

Study Results

No Results Posted as of Dec 8, 2022