Post Traumatic Stress DisorderNCT02891421
Therapeutic Horsemanship in Veterans
A study testing Therapeutic Horseback Riding in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by University of Missouri-Columbia.
Trial summary
The project partnered with U.S. military veterans with a premier accredited therapeutic riding center for six weeks. The veterans interacted with horses by grooming and learning about them, as well as riding them for one hour per week during which they gained a variety of skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- Therapeutic Horseback Riding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Feb 2015
- 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
- Age 18 years or older
- Veterans, left active military service (not serving in reserve units.)
- Diagnosed with Post Traumatic Stress Disorder/Traumatic Brain Injury or both according to ICD-9 diagnostic codes.
- Weight less than 220 pounds.
- Able to walk at least 25 feet without the assistance of a person (but potentially with assistive devices).
- Willing to interact with and ride a horse.
- Have not ridden a horse in the past year.
- Care Provider assent
Who cannot join
- Age less than 18 years
- Veterans in active military service (including reserve units).
- No diagnosis of PTSD/TBI or both according to ICD-9 diagnostic codes.
- Weight greater than 221 pounds.
- Unable to walk at least 25 feet without the assistance of a person (but potentially with assistive devices.)
- Unwilling to interact with and ride a horse.
- Have been riding a horse in the past year.
- Care Provider unwilling to provide assent
About this study
Official title: Effects of Equine Assisted Activities on PTSD Symptoms, Coping Self-efficacy, Emotion Regulation, and Social Engagement in U.S. Military Veterans
The project partnered with U.S. military veterans with a premier accredited therapeutic riding center for six weeks. The veterans interacted with horses by grooming and learning about them, as well as riding them for one hour per week during which they gained a variety of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and emotional health and self-efficacy.
Read the detailed description
Large numbers of post-deployed U.S. veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and/or Traumatic Brain Injury make effective interventions urgent, to reduce symptoms and increase veterans' coping. PTSD includes anxiety, flashbacks, and emotional numbing. Symptoms expand health care costs for stress-related illnesses making veterans' civilian life difficult.
The proposed study used a randomized experimental design with repeated measures and waitlist control group testing the efficacy of a 6-week human-horse interaction and systematic therapeutic horseback riding program in: decreasing PTSD symptoms, increasing coping self efficacy, emotion regulation, and social engagement. The Riding Group spent one hour weekly interacting with and riding the same horse at one of two PATH-accredited riding centers in Mid-Missouri supervised by an Occupational Therapist, Profession Association of Therapeutic Horsemanship (PATH) International-certified instructor, leader and side walkers as needed. Riding was directed by a systematic lesson plan. Data collection occured at baseline, 3 weeks, and 6 weeks. The Control Group was assessed at the same intervals and again 3 weeks and 6 weeks after joining the Riding Group.
- Being tested
- Therapeutic Horseback Riding, Standard Care
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Horseback RidingBehavioural
Veterans were matched to a horse for best fit and the same horse was ridden each week. The warm-up exercises involved various repeated physical movements while the horse was walking or standing steady, such as head rotations, lifting arms, rotating ankles, flexing toes. The exercises began with riding at a walk during the early weeks, learning reining skills and riding positions, and progressed to light trotting. Veteran participants were able to build on skill sets related to grooming, tacking, mounting, and riding that were introduced in prior weeks. Skill progression was based on individual abilities and safety as determined by certified riding instructor and occupational therapist.
Standard CareOther
Standard Care: Participants received standard care
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Horseback Riding | Other | Therapeutic Horseback Riding: Veterans were matched to a horse by the instructor and occupational therapist for best fit and the same horse was ridden each week Receives: Behavioral: Therapeutic Horseback Riding |
| Standard Care | Other | Participants received standard care. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Coping Self-Efficacy Scale (CSES)
26 item, 11 point analog scale
Measured: Day 1, 3 weeks and 6 weeks
Change in Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
17 item, 5 point scale
Measured: Day 1, 3 weeks and 6 weeks
Secondary outcomes (2)
Change in Social and Emotional Loneliness Scale for Adults (SELSA) scale
15 item, 7 point Likert-type scale.
Measured: Day 1, 3 weeks and 6 weeks
Change in Difficulties in Emotion Regulation Scale (DERS)
36 item, 5 point Likert-type scale
Measured: Day 1, 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Harry S. Truman Memorial Veterans' Hospital, Horses and Humans Research Foundation
- Responsible party
- Principal investigator, Rebecca Johnson, University of Missouri-Columbia
- Investigators
- Rebecca A Johnson, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891421
- Sponsor's protocol ID
- 1207664-1
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
Publications
Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
PubMed 17636720Brewin CR, Andrews B, Valentine JD. Meta-analysis of risk factors for posttraumatic stress disorder in trauma-exposed adults. J Consult Clin Psychol. 2000 Oct;68(5):748-66. doi: 10.1037//0022-006x.68.5.748.
PubMed 11068961Hakanson M, Moller M, Lindstrom I, Mattsson B. The horse as the healer-a study of riding in patients with back pain. J Bodyw Mov Ther. 2009 Jan;13(1):43-52. doi: 10.1016/j.jbmt.2007.06.002. Epub 2007 Aug 24.
PubMed 19118792Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.
PubMed 18234750
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Equine Assisted Activities on PTSD Symptoms, Coping Self-efficacy, Emotion Regulation, and Social Engagement in U.S. Military Veterans
- ClinicalTrials.gov ID
- NCT02891421
- Acronym / sponsor ID
- 1207664-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Harry S. Truman Memorial Veterans' Hospital, Horses and Humans Research Foundation
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Sep 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.
The project partnered with U.S. military veterans with a premier accredited therapeutic riding center for six weeks. The veterans interacted with horses by grooming and learning about them, as well as riding them for one hour per week during which they gained a variety of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and emotional health and self-efficacy.
Detailed description
Large numbers of post-deployed U.S. veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and/or Traumatic Brain Injury make effective interventions urgent, to reduce symptoms and increase veterans' coping. PTSD includes anxiety, flashbacks, and emotional numbing. Symptoms expand health care costs for stress-related illnesses making veterans' civilian life difficult.
The proposed study used a randomized experimental design with repeated measures and waitlist control group testing the efficacy of a 6-week human-horse interaction and systematic therapeutic horseback riding program in: decreasing PTSD symptoms, increasing coping self efficacy, emotion regulation, and social engagement. The Riding Group spent one hour weekly interacting with and riding the same horse at one of two PATH-accredited riding centers in Mid-Missouri supervised by an Occupational Therapist, Profession Association of Therapeutic Horsemanship (PATH) International-certified instructor, leader and side walkers as needed. Riding was directed by a systematic lesson plan. Data collection occured at baseline, 3 weeks, and 6 weeks. The Control Group was assessed at the same intervals and again 3 weeks and 6 weeks after joining the Riding Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Horseback Riding | Other | Behavioral: Therapeutic Horseback RidingTherapeutic Horseback Riding: Veterans were matched to a horse by the instructor and occupational therapist for best fit and the same horse was ridden each week |
| Standard Care | Other | Other: Standard CareParticipants received standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Veterans, left active military service (not serving in reserve units.)
- Diagnosed with Post Traumatic Stress Disorder/Traumatic Brain Injury or both according to ICD-9 diagnostic codes.
- Weight less than 220 pounds.
- Able to walk at least 25 feet without the assistance of a person (but potentially with assistive devices).
Key exclusion criteria (8 listed)
- Age less than 18 years
- Veterans in active military service (including reserve units).
- No diagnosis of PTSD/TBI or both according to ICD-9 diagnostic codes.
- Weight greater than 221 pounds.
- Unable to walk at least 25 feet without the assistance of a person (but potentially with assistive devices.)
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 |
|---|---|---|
| Therapeutic Horseback RidingVeterans were matched to a horse for best fit and the same horse was ridden each week. The warm-up exercises involved various repeated physical movements while the horse was walking or standing steady, such as head rotations, lifting arms, rotating ankles, flexing toes. The exercises began with riding at a walk during the early weeks, learning reining skills and riding positions, and progressed to light trotting. Veteran participants were able to build on skill sets related to grooming, tacking, mounting, and riding that were introduced in prior weeks. Skill progression was based on individual abilities and safety as determined by certified riding instructor and occupational therapist. | Behavioural | Therapeutic Horseback Riding |
| Standard CareStandard Care: Participants received standard care | Other | Standard Care |
Primary outcome
Change in Coping Self-Efficacy Scale (CSES)
Time frame: Day 1, 3 weeks and 6 weeks
26 item, 11 point analog scale
Change in Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Time frame: Day 1, 3 weeks and 6 weeks
17 item, 5 point scale
2 secondary outcomes
Change in Social and Emotional Loneliness Scale for Adults (SELSA) scale
Time frame: Day 1, 3 weeks and 6 weeks
Change in Difficulties in Emotion Regulation Scale (DERS)
Time frame: Day 1, 3 weeks and 6 weeks
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 7 Sep 2016.
- Background: PubMed 17636720Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
- Background: PubMed 11068961Brewin CR, Andrews B, Valentine JD. Meta-analysis of risk factors for posttraumatic stress disorder in trauma-exposed adults. J Consult Clin Psychol. 2000 Oct;68(5):748-66. doi: 10.1037//0022-006x.68.5.748.
- Background: PubMed 19118792Hakanson M, Moller M, Lindstrom I, Mattsson B. The horse as the healer-a study of riding in patients with back pain. J Bodyw Mov Ther. 2009 Jan;13(1):43-52. doi: 10.1016/j.jbmt.2007.06.002. Epub 2007 Aug 24.
- Background: PubMed 18234750Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.
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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.
Rebecca A Johnson, PhD principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Horseback Riding in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by University of Missouri-Columbia.
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 8 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Coping Self-Efficacy Scale (CSES) (time frame: Day 1, 3 weeks and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02891421, which also lists 4 linked publications.
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 7 Sep 2016.