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The Role of Exercise in the Treatment of PTSD Symptoms

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
imaginal therapy
exercise
self-care
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring exercise, biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • be an Active Duty, Reserve, or National Guard Army, Air Force, Navy, or Marine Veteran of Operation Iraqi Freedom (OIF) / Operation Enduring Freedom (OEF) eligible for military medical care
  • be at least 18 years old
  • be able to read and speak English
  • answer "no" to the seven questions of the Physical Activity Readiness Questionnaire (PAR-Q), or have primary care provider approval to undertake an exercise program.
  • score ≥25 on the PTSD CheckList - Stressor-Specific(PCL-S); participants scoring >50 on the PCL-S will be contacted weekly to ensure that their symptoms are under control and they do not require a higher level of care.
  • report on the PTSD Symptom Scale - Interview (PSS-I) an exposure to a traumatic event (Criterion A), at least one re-experiencing symptom (Criterion B), and at least one avoidance symptom (Criterion C)
  • participants taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the 1-month follow-up assessment as much as possible and as medically indicated
  • anticipate being in the area for at least three months to complete intervention and 13-week follow-up assessment

Exclusion Criteria:

  • score <25 on the PTSD CheckList - Stressor Specific (PCL-S) (Those scoring <25 do not have enough symptom severity to adequately test the study hypotheses
  • have undergone exposure therapy for PTSD within the last year
  • be taking benzodiazepines every day on a prescribed schedule (Individuals prescribed and taking a benzodiazepine only as needed will not be excluded.)
  • suicidal ideation with moderate to severe intent warranting intervention
  • active psychosis or mania
  • be on a medical profile that prohibits exercise

Sites / Locations

  • Carl R. Darnall Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Imaginal Therapy Only

Exercise Only

Imaginal Therapy & Exercise Combined

Nurse-led Self-Care

Arm Description

The imaginal exercise of exposure therapy will be manualized (Rothbaum, Foa & Hembree, 2007) and adapted with the permission of Dr. Foa for combat-related stress disorders (Peterson, Cigrang & Riggs, 2008). While traditional exposure therapy includes both imaginal exposure and in vivo exposure, this study will use only the imaginal exposure components. Participants will meet with a therapist the first week of treatment and every-other week for a total of five appointments over eight weeks. During the second session, the therapist will help the participant make an approximately 20-minute voice tape recording of their traumatic experience which they will listen to 5-days/week. A new recording will be made with the therapist during sessions 3 and 4 also, for a total of three tapes.

The aerobic exercise regimen will be standardized according to the American College of Sports Medicine recommendations: frequency of a minimum of 5 sessions per week, at a vigorous intensity [>60% of oxygen uptake reserve (VO2R)], time of 20-25 minutes per exercise session. To determine the exercise heart rate intensity, the Karvonen formula for heart rate reserve will be used. The mode of exercise will be purposeful walking or jogging. The goal of the exercise is not training, but rather to keep the participant's heart rate >60% of their individually-determined heart rate reserve.

Participants will meet with a therapist the first week of treatment and every-other week for a total of five appointments over eight weeks. During the second session, the therapist will help the participant make an approximately 20-minute voice tape recording of their traumatic experience which they will listen to 5-days/week. A new recording will be made with the therapist during sessions 3 and 4 also, for a total of three tapes. Participants will exercise listening to their tape at least 5-times/week outside of scheduled unit Physical Training. Participants will wear the heart rate monitor to record their exercise activity.

The Self-Care Group will use written materials that outline the benefits of thinking about problems the individual is facing as well as the benefits of exercise, however doing the two activities together will not be advocated as part of the material. A fact sheet prepared by the National Center for PTSD, Returning from the War Zone: A Guide for Military Personnel as well as a list of coping strategies and self-care behaviors adapted from the National Center for PTSD guide, Self-Care and Self-Help Following Disasters, will be used to guide the discussion. The research nurse will meet with the participant five times over 8-weeks at weeks 1, 2, 4, 6, and 8 to encourage use of the self-care fact sheet and assess the participant for safety.

Outcomes

Primary Outcome Measures

PTSD symptoms as assessed using the PTSD Symptom Scale - Interview (PSS-I) and PTSD CheckList (PCL)
degree of PTSD symptoms

Secondary Outcome Measures

Full Information

First Posted
January 4, 2016
Last Updated
September 8, 2017
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
C.R.Darnall Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02649127
Brief Title
The Role of Exercise in the Treatment of PTSD Symptoms
Official Title
The Role of Exercise in the Treatment of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
C.R.Darnall Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an 8-week experimental, repeated-measures clinical trial randomizing 120 Service Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic exercise, or 4) self-care.
Detailed Description
One of the signature injuries of combat operations following 9/11 is posttraumatic stress disorder (PTSD). The most effective treatment for PTSD is exposure therapy where, under the supervision of a trained therapist, individuals are exposed to prolonged and repeated imagined images of the trauma until the images no longer cause severe anxiety. Various forms of exercise have been used to treat a broad range of depression and anxiety disorders and exercise has been used with some success to treat individuals with PTSD. Considering the population of otherwise healthy and physically active Service Members suffering from symptoms of PTSD, it seems possible that exercise might serve as an outlet for the emotional reactions experienced during therapy, decreasing emotional distress, and increasing the individual's tolerance to imaginal exposure serving as a powerful adjunct to exposure therapy. The purpose of this study to explore the role of exercise in the treatment of symptoms of posttraumatic stress disorder (PTSD), specifically determining if the efficacy of imaginal exercises, part of exposure therapy for PTSD, can be improved by augmenting the therapy with aerobic exercise. Towards this end, this 8-week experimental, repeated-measures clinical trial will randomize 120 Service Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic exercise, or 4) self-care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
exercise, biomarker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaginal Therapy Only
Arm Type
Experimental
Arm Description
The imaginal exercise of exposure therapy will be manualized (Rothbaum, Foa & Hembree, 2007) and adapted with the permission of Dr. Foa for combat-related stress disorders (Peterson, Cigrang & Riggs, 2008). While traditional exposure therapy includes both imaginal exposure and in vivo exposure, this study will use only the imaginal exposure components. Participants will meet with a therapist the first week of treatment and every-other week for a total of five appointments over eight weeks. During the second session, the therapist will help the participant make an approximately 20-minute voice tape recording of their traumatic experience which they will listen to 5-days/week. A new recording will be made with the therapist during sessions 3 and 4 also, for a total of three tapes.
Arm Title
Exercise Only
Arm Type
Experimental
Arm Description
The aerobic exercise regimen will be standardized according to the American College of Sports Medicine recommendations: frequency of a minimum of 5 sessions per week, at a vigorous intensity [>60% of oxygen uptake reserve (VO2R)], time of 20-25 minutes per exercise session. To determine the exercise heart rate intensity, the Karvonen formula for heart rate reserve will be used. The mode of exercise will be purposeful walking or jogging. The goal of the exercise is not training, but rather to keep the participant's heart rate >60% of their individually-determined heart rate reserve.
Arm Title
Imaginal Therapy & Exercise Combined
Arm Type
Experimental
Arm Description
Participants will meet with a therapist the first week of treatment and every-other week for a total of five appointments over eight weeks. During the second session, the therapist will help the participant make an approximately 20-minute voice tape recording of their traumatic experience which they will listen to 5-days/week. A new recording will be made with the therapist during sessions 3 and 4 also, for a total of three tapes. Participants will exercise listening to their tape at least 5-times/week outside of scheduled unit Physical Training. Participants will wear the heart rate monitor to record their exercise activity.
Arm Title
Nurse-led Self-Care
Arm Type
Active Comparator
Arm Description
The Self-Care Group will use written materials that outline the benefits of thinking about problems the individual is facing as well as the benefits of exercise, however doing the two activities together will not be advocated as part of the material. A fact sheet prepared by the National Center for PTSD, Returning from the War Zone: A Guide for Military Personnel as well as a list of coping strategies and self-care behaviors adapted from the National Center for PTSD guide, Self-Care and Self-Help Following Disasters, will be used to guide the discussion. The research nurse will meet with the participant five times over 8-weeks at weeks 1, 2, 4, 6, and 8 to encourage use of the self-care fact sheet and assess the participant for safety.
Intervention Type
Behavioral
Intervention Name(s)
imaginal therapy
Intervention Description
imaginal exercise of Prolonged Exposure therapy
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
aerobic training at a frequency of a minimum of 3 sessions per week, at vigorous intensity [i. e., >60% of oxygen uptake reserve (VO2R)], and a time of 20-25 minutes each bout of training
Intervention Type
Behavioral
Intervention Name(s)
self-care
Intervention Description
meeting with a nurse to review and discuss publically available written materials that outline approaches for dealing with posttraumatic stress symptoms
Primary Outcome Measure Information:
Title
PTSD symptoms as assessed using the PTSD Symptom Scale - Interview (PSS-I) and PTSD CheckList (PCL)
Description
degree of PTSD symptoms
Time Frame
change in score between baseline, 1-week post-treatment, 1-month post-treatment, 6-months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be an Active Duty, Reserve, or National Guard Army, Air Force, Navy, or Marine Veteran of Operation Iraqi Freedom (OIF) / Operation Enduring Freedom (OEF) eligible for military medical care be at least 18 years old be able to read and speak English answer "no" to the seven questions of the Physical Activity Readiness Questionnaire (PAR-Q), or have primary care provider approval to undertake an exercise program. score ≥25 on the PTSD CheckList - Stressor-Specific(PCL-S); participants scoring >50 on the PCL-S will be contacted weekly to ensure that their symptoms are under control and they do not require a higher level of care. report on the PTSD Symptom Scale - Interview (PSS-I) an exposure to a traumatic event (Criterion A), at least one re-experiencing symptom (Criterion B), and at least one avoidance symptom (Criterion C) participants taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the 1-month follow-up assessment as much as possible and as medically indicated anticipate being in the area for at least three months to complete intervention and 13-week follow-up assessment Exclusion Criteria: score <25 on the PTSD CheckList - Stressor Specific (PCL-S) (Those scoring <25 do not have enough symptom severity to adequately test the study hypotheses have undergone exposure therapy for PTSD within the last year be taking benzodiazepines every day on a prescribed schedule (Individuals prescribed and taking a benzodiazepine only as needed will not be excluded.) suicidal ideation with moderate to severe intent warranting intervention active psychosis or mania be on a medical profile that prohibits exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Young-McCaughan, RN, PhD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carl R. Darnall Army Medical Center
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76544
Country
United States

12. IPD Sharing Statement

Links:
URL
http://tango.uthscsa.edu/strongstar/subs/afinfo.asp?prj=17
Description
STRONG STAR Consortium web link describing study
URL
http://www.runnersworld.com/runners-stories/running-back-from-hell
Description
Runner's World article, Running back from hell

Learn more about this trial

The Role of Exercise in the Treatment of PTSD Symptoms

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