NCT05591404

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
3.1 years until next milestone

Study Start

First participant enrolled

November 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

October 19, 2022

Last Update Submit

November 25, 2025

Conditions

Social Stress

Keywords

Social StressfMRI

Outcome Measures

Primary Outcomes (1)

  • 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.

    45 minutes after TSST

Secondary Outcomes (2)

  • Change in Acute Subjective Anxiety

    -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes

  • Differences in Salivary Alpha Amylase

    -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes

Study Arms (2)

Film + TSST

EXPERIMENTAL

Nature Film + Trier Social Stress Test (TSST)

Behavioral: Trier Social Stress Test (TSST)

Film Only (No-TSST)

NO INTERVENTION

Nature Film Only

Interventions

Trier Social Stress Test (TSST)BEHAVIORAL

Participants randomized to the TSST arm will experience the Trier Social Stress Test.

Film + TSST

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Liebowitz Social Anxiety Scale (LSAS \<30).

You may not qualify if:

  • 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 benzodiazepines in past 2 weeks.
  • Use of alpha- or beta-blockers in the past week.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Psychological Tests

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • John Gabrieli, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Rutledge, MS

CONTACT

617-324-2898orutledge@mit.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

November 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

All data, code, and materials used in the analyses will be made available upon request by John Gabrieli and Massachusetts Institute of Technology after scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Any requests should be submitted to John Gabrieli at gabrieli@mit.edu.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will become available beginning one year after publication of the results.
Access Criteria
Data will be provided pending a scientific review and a completed data use agreement/material transfer agreement. Requests should be submitted to John Gabrieli at gabrieli@mit.edu.

Locations

US(1)