Posttraumatic Stress Disorder Clinical Trial
— THRICFOfficial title:
Examination of the Effects of Equine Assisted Activities [EAA] on Symptoms, Quality of Life and Functioning in Veterans With PTSD: An International Classification of Functioning, Disability and Health [ICF] Approach
NCT number | NCT02893202 |
Other study ID # | EAAVeterans |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | June 2016 |
Verified date | July 2023 |
Source | Baylor University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - had a diagnosis of bipolar, schizophrenia, or presence of psychosis - active substance dependence within the last three months - significant cognitive impairment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Baylor University | Horses and Humans Research Foundation |
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. — View Citation
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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in behavior by participating in the program assessed with a semi-structured questionnaire | semi-structured questions designed to elicit responses about changes in behavior by participating in the program. | 8 weeks | |
Secondary | Change in Disability and Functioning | WHODAS 2 was used to measure level of functioning at each time point | baseline, 4 weeks, 8 weeks, and 2 month post intervention | |
Secondary | Change in Quality of life | SF36v2 was used to measure quality of life at each time point | baseline, 4 weeks, 8 weeks, and 2 month post intervention | |
Secondary | Change in Depression symptoms | Major Depression Inventory was used to measure depression symptoms at each time point | baseline, 4 weeks, 8 weeks, and 2 month post intervention |
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