Posttraumatic Stress DisorderNCT02649127
The Role of Exercise in the Treatment of PTSD Symptoms
A study testing imaginal therapy, exercise and self-care in people with Posttraumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- imaginal therapy, exercise and self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
About this study
Official title: The Role of Exercise in the Treatment of PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- imaginal therapy, exercise, self-care
- Keywords
- exercise, biomarker
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaginal therapyBehavioural
imaginal exercise of Prolonged Exposure therapy
exerciseBehavioural
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
self-careBehavioural
meeting with a nurse to review and discuss publically available written materials that outline approaches for dealing with posttraumatic stress symptoms
| Study group | Role | What they receive |
|---|---|---|
| Imaginal Therapy Only | Experimental | 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. Receives: Behavioral: imaginal therapy |
| Exercise Only | Experimental | 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. Receives: Behavioral: exercise |
| Imaginal Therapy & Exercise Combined | Experimental | 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. Receives: Behavioral: imaginal therapy; Behavioral: exercise |
| Nurse-led Self-Care | Active comparator | 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. Receives: Behavioral: self-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms as assessed using the PTSD Symptom Scale - Interview (PSS-I) and PTSD CheckList (PCL)
degree of PTSD symptoms
Measured: change in score between baseline, 1-week post-treatment, 1-month post-treatment, 6-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startFeb 2011
- Primary completionAug 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- C.R.Darnall Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Stacey Young-McCaughan, RN, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649127
- Sponsor's protocol ID
- HSC20100372H
- Status last verified
- Sep 2016
- First submitted
- 4 Jan 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exercise in the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT02649127
- Acronym / sponsor ID
- HSC20100372H
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- exercise, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- C.R.Darnall Army Medical Center
- Study start
- Feb 2011 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Imaginal Therapy Only | Experimental | Behavioral: imaginal therapyThe 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. |
| Exercise Only | Experimental | Behavioral: exerciseThe 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. |
| Imaginal Therapy & Exercise Combined | Experimental | Behavioral: imaginal therapy, Behavioral: exerciseParticipants 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. |
| Nurse-led Self-Care | Active comparator | Behavioral: self-careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaginal therapyimaginal exercise of Prolonged Exposure therapy | Behavioural | Imaginal Therapy & Exercise Combined, Imaginal Therapy Only |
| exerciseaerobic 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 | Behavioural | Exercise Only, Imaginal Therapy & Exercise Combined |
| self-caremeeting with a nurse to review and discuss publically available written materials that outline approaches for dealing with posttraumatic stress symptoms | Behavioural | Nurse-led Self-Care |
Primary outcome
PTSD symptoms as assessed using the PTSD Symptom Scale - Interview (PSS-I) and PTSD CheckList (PCL)
Time frame: change in score between baseline, 1-week post-treatment, 1-month post-treatment, 6-months post-treatment
degree of PTSD symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- STRONG STAR Consortium web link describing studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Young-McCaughan, RN, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaginal therapy, exercise and self-care in people with Posttraumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms as assessed using the PTSD Symptom Scale - Interview (PSS-I) and PTSD CheckList (PCL) (time frame: change in score between baseline, 1-week post-treatment, 1-month post-treatment, 6-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.