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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02891421
Other study ID # 1207664-1
Secondary ID
Status Completed
Phase N/A
First received September 1, 2016
Last updated September 1, 2016
Start date May 2013
Est. completion date February 2015

Study information

Verified date September 2016
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Therapeutic Horseback Riding
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.
Other:
Standard Care
Standard Care: Participants received standard care

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Missouri-Columbia Harry S Truman Memorial Veterans Hospital, Columbia, Missouri, Horses and Humans Research Foundation

References & Publications (4)

Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. Review. Update in: Cochrane Database Syst Rev. 2013;12:CD003388. — View Citation

Brewin 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. — View Citation

Håkanson M, Möller M, Lindström 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. — View Citation

Hoge 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Coping Self-Efficacy Scale (CSES) 26 item, 11 point analog scale Day 1, 3 weeks and 6 weeks No
Primary Change in Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M) 17 item, 5 point scale Day 1, 3 weeks and 6 weeks No
Secondary Change in Social and Emotional Loneliness Scale for Adults (SELSA) scale 15 item, 7 point Likert-type scale. Day 1, 3 weeks and 6 weeks No
Secondary Change in Difficulties in Emotion Regulation Scale (DERS) 36 item, 5 point Likert-type scale Day 1, 3 weeks and 6 weeks No
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