Brief Exposure and Exercise for PTSD.

NCT07080606 | Completed

• 1 other identifier: 101765
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if 8 sessions of brief exposure and exercise therapy works to treat Post Traumatic Stress Disorder (PTSD) in adults. This study will also learn if participants think brief exposure and exercise therapy is a good and doable treatment. and The main questions it aims to answer are:

• Do participants find brief exposure and exercise an acceptable and feasible means of treatment for PTSD?
• Does brief exposure and exercise decreases of the severity of PTSD symptoms? Participants will:
• Complete weekly questionnaires for 10-14 weeks.
• Attend 8 twice weekly exposure therapy and exercise sessions for 4 weeks.

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; Exercise; Exposure Therapy

Outcome Measures

Primary Outcomes (3)

• Change in PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a 20-item self-report questionnaire used to assess PTSD symptom severity. Each of the 20 PCL-5 items corresponds to symptoms of PTSD in the DSM-5. Items are rated on a Likert scale from 0 (not at all) to 4 (extremely) based upon how bothered participants are by each symptom. Items on the PCL-5 are summed, resulting in a total score of PTSD symptom severity from 0-80. Scores \>30 indicate probable PTSD.

  Up to 15 weeks.

• Patient Satisfaction Questionnaire Scores

  Acceptability will be assessed using a patient satisfaction questionnaire. The 5 Items on the patient satisfaction questionnaire are rated on a 4 likert scale with higher scores on the indicating better perceptions of treatment. Total satisfaction of treatment can be obtained by averaging scores across the 5 items.

  Once at end of treatment (up to 9 weeks).

• Feasibility of the intervention

  Feasibility will be analyzed by examining adherence to the treatment protocol checklist. An average score of 80% treatment adherence for all participants will be used as a threshold to define the feasibility of this intervention.

  4 weeks of treatment following the 3-to 5-week baseline.

Secondary Outcomes (3)

• Changes in Brief Experiential Avoidance Questionnaire

  Up to 15 weeks

• Changes in the posttraumatic cognitions inventory-9 (PTCI-9)

  Up to 15 weeks.

• Changes in the positive and negative valence affect schedule (PANAS)

  Up to 15 weeks.

Study Arms (3)

Brief exposure therapy and exercise 3 week

EXPERIMENTAL

Participants are randomized into the 3 week baseline condition before receiving the exposure therapy and exercise intervention.

Behavioral: Brief exposure therapy and exercise

Brief exposure therapy and exercise 5 week

EXPERIMENTAL

Participants are randomized into the 5 week baseline condition before receiving the exposure therapy and exercise intervention.

Behavioral: Brief exposure therapy and exercise

Brief exposure therapy and exercise 4 week

EXPERIMENTAL

Participants are randomized into the 4 week baseline condition before receiving the exposure therapy and exercise intervention.

Behavioral: Brief exposure therapy and exercise

Interventions

Brief exposure therapy and exercise BEHAVIORAL

Treatment provided in this study includes an open label brief imaginal exposure therapy for Post Traumatic Stress Disorder (PTSD) and moderate intensity aerobic exercise (i.e., 70-75% max heart rate). Participants all receive 30 minutes of psychotherapy and 25 minutes of exercise.

Also known as: Imaginal Exposure

Brief exposure therapy and exercise 3 week; Brief exposure therapy and exercise 4 week; Brief exposure therapy and exercise 5 week

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provide informed consent and are willing to participate in therapy sessions twice weekly, which include moderate-intensity aerobic exercise.
• Participants must be adults aged 18-64 meeting the criteria for PTSD within the past month, who are not currently receiving treatment from other psychotherapy or are on unstable psychiatric medication (i.e., less than four weeks of psychiatric medication).
• Participants should be able to engage in 25 minutes of moderate-intensity aerobic exercise (i.e., 70-75% of max heart rate).
• Participants must be able to speak and read English fluently to participate in the current study.

You may not qualify if:

• Participants who endorse health condition(s) that would prevent moderate exercise.
• Participants who endorse (i.e., "yes") any items on the Physical Activity Readiness Questionnaire (PARQ) that is not controlled or managed.
• Participants with any injuries to the lower extremities that may hinder riding an exercise bicycle.
• Participants currently seeking or undergoing any other trauma-focused psychotherapy treatment.

Sponsors & Collaborators

• Troy Hubert: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Links

• A Github repository hosting data, analytic plan, and analytic R code.

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Motor Activity

Interventions

Exercise; Implosive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica Burris, Ph.D.

  University of Kentucky

  STUDY DIRECTOR

• Shannon Sauer-Zavala, Ph.D.

  University of Kentucky

  STUDY DIRECTOR

• Troy J.J. Hubert, M.S.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Research Assistant

Model Details: Acceptability and Feasibility using a Single Case Experimental Design

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 23, 2025
• Study Start: June 25, 2025
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be released before the completion of the first participant and stored after the completion of the study. Data analytic plan and analytic code will be stored on github indefinitely.
• Access Criteria: The full de-identified dataset will be released by PI to other researchers upon request. The small de-identified dataset of variables used for primary analysis, the data dictionary, data analytic plan, and the R analytic code will be stored on Github and OSF.

Locations

US (1)