NCT06144203

Brief Summary

This study aims to test whether aerobic exercise performed after fear extinction learning improves cognitive, physiological, and neural indices of extinction recall in a sample of trauma-exposed men and women with and without posttraumatic stress disorder (PTSD). Participants will complete a clinical intake visit (Day 0), followed by a three-day fear conditioning (day 1), fear extinction + activity (day 2), and fear extinction recall (day 3) protocol.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Jan 2024

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2024Mar 2029

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2024

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

5.1 years

First QC Date

November 16, 2023

Last Update Submit

February 13, 2024

Conditions

PTSD

Outcome Measures

Primary Outcomes (3)

  • Skin conductance responses

    SCR data will be collected while participants are completing the cognitive task in the MRI environment.

    Collected during fear conditioning, fear extinction, and extinction recall task.

  • Threat expectancy ratings

    Threat expectancy ratings will be collected while participants are completing the cognitive task in the MRI environment.

    Collected during fear conditioning, fear extinction, and extinction recall task.

  • Neural activity

    Neural activity will be collected while participants are completing the cognitive task in the MRI environment.

    Collected during fear conditioning, fear extinction, and extinction recall task.

Study Arms (3)

Light-intensity aerobic exercise

EXPERIMENTAL
Behavioral: Exercise

Moderate-intensity aerobic exercise

EXPERIMENTAL
Behavioral: Exercise

High-intensity aerobic exercise

EXPERIMENTAL
Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Participants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits.

High-intensity aerobic exerciseLight-intensity aerobic exerciseModerate-intensity aerobic exercise

Eligibility Criteria

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

You may qualify if:

  • male or female sex
  • right-handed
  • age 18-64
  • a current diagnosis of PTSD where the index event involves interpersonal violence exposure (e.g., physical/sexual assault).
  • male or female sex
  • right-handed
  • age 18-64
  • interpersonal violence exposure (e.g., physical/sexual assault).

You may not qualify if:

  • current substance use disorder (other than alcohol, nicotine, or cannabis)
  • acute suicidality
  • history of bipolar/psychotic disorder
  • changes to or addition of psychiatric medication in the past 4 weeks (6 weeks for fluoxetine)
  • medications that effect neurovascular properties upon which BOLD fMRI capitalizes (e.g., water pills)
  • history of neurological disorders or disease (e.g., traumatic brain injury, epilepsy, seizures)
  • loss of consciousness \> 10 minutes
  • intellectual disabilities (IQ\<70)
  • developmental disorders
  • MRI contraindication (e.g., internal ferromagnetic objects such as electronic devices, surgical implants, shrapnel; see phone screen)
  • claustrophobia or the inability to lie still in a confined space
  • physical disabilities that prohibit task performance (e.g., blindness or deafness)
  • positive pregnancy test
  • cochlear implant
  • an implanted neurostimulator
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wade Hall - University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kevin Crombie, PhD

CONTACT

2053482684kmcrombie@ua.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

January 29, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

US(1)