NCT05203731

Brief Summary

The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

January 20, 2022

Last Update Submit

February 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Skin Conductance Response (SCR)

    SCR will be computed for each trial by subtracting the mean skin conductance level observed during the last two seconds of context presentation from the maximal skin conductance level reached during CS presentation. All SCR values will be square-root transformed prior to any statistical analyses. To evaluate extinction recall, an extinction retention index (ERI) will be computed for each individual using the following formula: 100 - (mean SCR to the first 4 CS+E trials during recall / maximum SCR reached during conditioning for this same cue) \* 100

    Day 2 Visit

  • Heart rate (HR)

    HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.

    Day 2 Visit

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants who will be randomized to moderate intensity exercise after extinction (Day 1)

Behavioral: Exercise

Seated group

SHAM COMPARATOR

Participants who will be randomized to sitting after extinction (Day 1)

Behavioral: Sitting

Interventions

SittingBEHAVIORAL

Sitting will occur for 20 minutes after the emotional learning procedures on Day 1.

Seated group
ExerciseBEHAVIORAL

Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.

Exercise Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females ages 18-60
  • A primary diagnosis of a DSM-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder)
  • Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
  • Able and willing to provide informed consent

You may not qualify if:

  • Lifetime Bipolar Disorder or psychosis
  • Past 3 months substance use disorder or eating disorder
  • Current PTSD (past PTSD \> 6 months prior to screening is allowed)
  • High risk for exercise according to the Physical Activity Readiness Questionnaire and American College of Sports Medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
  • Women who are currently pregnant
  • Acute suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Benzodiazepine use
  • Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
  • Stable psychiatric medications for at least 4 weeks prior to experimental procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderPhobia, SocialPanic Disorder

Interventions

ExerciseSitting Position

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPosture

Study Officials

  • Kristin Szuhany, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 20, 2022

First Posted

January 24, 2022

Study Start

January 31, 2023

Primary Completion

March 19, 2025

Study Completion

March 19, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

This pilot study is not funded to support data sharing in a small pilot sample size. The Brain \& Behavior Research Foundation (funder) does not require data sharing. However, individual requests for deidentified data will be considered in the future, if appropriate.

Locations