Clinical trial NCT05591404: Investigating the Effects of Social Stress on Brain Imaging
Official title: Investigating the Effects of Social Stress on Brain Imaging
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Social Stress
Keywords: Social Stress
fMRI
Lead sponsor: Massachusetts Institute of Technology
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2022-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in fMRI BOLD Response
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Massachusetts Institute of Technology
name: John Gabrieli, PhD
role: PRINCIPAL_INVESTIGATOR
References: