NCT02893202

Brief Summary

The purpose of the research project was to assess changes in Posttraumatic stress disorder \[PTSD\] symptoms, quality of life and participation of combat veteran who participate in equine assisted activities \[EAA\]. The study used a mixed-methods, waitlist-controlled, repeated measures trial of a standardized 8-week therapeutic riding intervention for combat veterans with PTSD. Behavioral changes were assessed four times during the study. Veterans meeting inclusion criteria were selected to participate in either the intervention group or the control/waitlist group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

August 30, 2016

Last Update Submit

July 28, 2023

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDEquine assisted activitiesquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD symptoms

    PCL-5 to measure PTSD symptoms at each time point

    baseline, 4 weeks, 8 weeks, and 2 month post intervention

Secondary Outcomes (4)

  • Change in behavior by participating in the program assessed with a semi-structured questionnaire

    8 weeks

  • Change in Disability and Functioning

    baseline, 4 weeks, 8 weeks, and 2 month post intervention

  • Change in Quality of life

    baseline, 4 weeks, 8 weeks, and 2 month post intervention

  • Change in Depression symptoms

    baseline, 4 weeks, 8 weeks, and 2 month post intervention

Study Arms (5)

Ride On Center for Kids (ROCK) facility

EXPERIMENTAL

8-week therapeutic horseback riding

Other: Therapeutic Horseback riding

Triple H Equitherapy Facility

EXPERIMENTAL

8-week therapeutic horseback riding

Other: Therapeutic Horseback riding

Rainer Therapeutic Riding facility

EXPERIMENTAL

8-week therapeutic horseback riding

Other: Therapeutic Horseback riding

REACH Therapeutic Riding facility

EXPERIMENTAL

8-week therapeutic horseback riding

Other: Therapeutic Horseback riding

Courtney Cares Riding facility

EXPERIMENTAL

8-week therapeutic horseback riding

Other: Therapeutic Horseback riding

Interventions

Therapeutic Horseback ridingOTHER

An 8-week equine-assisted program designed to especially for veterans. The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.

Courtney Cares Riding facilityREACH Therapeutic Riding facilityRainer Therapeutic Riding facilityRide On Center for Kids (ROCK) facilityTriple H Equitherapy Facility

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participated in any of the three Iraq and Afghanistan war missions Operation Enduring Freedom, \[OEF\], Operation Iraqi Freedom,\[OIF\], Operation New Dawn, \[OND\]
  • diagnosed with PTSD or exhibiting PTSD symptoms and confirmed using PCL-M or PCL-5 provisional diagnosis
  • not participated in equine assisted activities and therapies six months prior to the start of the study

You may not qualify if:

  • had a diagnosis of bipolar, schizophrenia, or presence of psychosis
  • active substance dependence within the last three months
  • significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.

    PMID: 21076562BACKGROUND

  • Ware, J. E., Kosinski, M., & Keller, S. D. (1994). SF-36 Physical and Mental Component Summary Measures: A User's Manual Boston: The Health Institute.

    BACKGROUND

  • Schneidert M, Hurst R, Miller J, Ustun B. The role of environment in the International Classification of Functioning, Disability and Health (ICF). Disabil Rehabil. 2003 Jun 3-17;25(11-12):588-95. doi: 10.1080/0963828031000137090.

    PMID: 12959332BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Beth A Lanning, PhD

    Baylor University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 8, 2016

Study Start

August 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share