Exercise and Exposure in PTSD

Sponsor

Thomas Adams (Other)

Overall Status

Recruiting

CT.gov ID

NCT05177458

Collaborator

(none)

Enrollment

Location

Arms

20.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed project seeks to demonstrate that a brief bout of aerobic exercise can improve a particular type of therapeutic learning among women with Posttraumatic Stress Disorder (PTSD).

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Experimental Behavioral: Active Control	N/A

Detailed Description

The proposed study has two aims:

Specific Aim 1: To examine the effects of acute exercise on the consolidation of therapeutic safety learning. It is hypothesized that participants who engage in 30-min of moderate-intensity aerobic exercise following the first session of imaginal exposure will show larger between-session (visit 2 to 3) reductions in heart rate and anxiety during imaginal exposure to trauma narratives compared to participants who engage in light-intensity exercise.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effects of Acute Aerobic Exercise on Therapeutic Safety Learning in PTSD

Actual Study Start Date :

Apr 14, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of moderate intensity (70-75% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.	Behavioral: Experimental Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% maximum heart rate) for 30 minutes on a treadmill.
Active Comparator: Control - Low Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of light intensity (40-50% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.	Behavioral: Active Control Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at 40-50% of maximum heart rate) for 30 minutes.

Arm

Intervention/Treatment

Experimental: Moderate Intensity Exercise

Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of moderate intensity (70-75% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.

Behavioral: Experimental

Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% maximum heart rate) for 30 minutes on a treadmill.

Active Comparator: Control - Low Intensity Exercise

Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of light intensity (40-50% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.

Behavioral: Active Control

Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at 40-50% of maximum heart rate) for 30 minutes.

Outcome Measures

Primary Outcome Measures

Change in participant heart rate [24 hours (visit 2), 48 hours (visit 3)]
Participant heart rate will be measured at baseline and after each imagery trial using a BIOPAC Bionomadix photo plethysmogram.
Change in participant subjective emotional ratings [24 hours (visit 2), 48 hours (visit 3)]
Participant anxiety will be measured at baseline and after each imagery trial.
Change in participant electrodermal response [24 hours (visit 2), 48 hours (visit 3)]
Participant skin conductance activity will be measured at baseline and during each imagery trial using a pair of BIOPAC Bionomadix electrodermal activity electrodes

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
English speaking
Medically healthy

Exclusion Criteria:

Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
Major medical disorders (such as cancer, AIDS)
Psychotic disorders
Intellectual disabilities
Developmental disorders
Active substance use disorders
Pregnancy or probably pregnancy
Body mass index greater than or equal to 35
Daily cannabis use
History of any cardiac disease
Inability to provide informed consent
Physical disabilities that prohibit task performance (such as deafness or blindness)
Self-reported history of loss of consciousness (greater than 30 minutes)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40505

Sponsors and Collaborators

Thomas Adams

Investigators

Principal Investigator: Thomas G Adams Jr, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Adams, Assistant Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT05177458

Other Study ID Numbers:

67199

First Posted:

Jan 4, 2022

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Adams, Assistant Professor, University of Kentucky

Study Results

No Results Posted as of Apr 22, 2022