PTSD Clinical Team Research Clinic (PCT Research Clinic)

PTSD Clinical Trial

Official title:

PTSD Clinical Team Research Clinic (PCT Research Clinic)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05422768
• Other study ID #: IRB_00136053
• Status: Active, not recruiting
• Start date: November 16, 2020
• Est. completion date: May 11, 2024

Study information

• Verified date: May 2023
• Source: VA Salt Lake City Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Part of the IRB_00136053 study was to look at the effectiveness of Warrior Renew and Warrior Renew+EAL interventions. Furthermore, demographic information on Veteran participants will be analyzed.

Description:

EAL is one of a group of equine-assisted services (EAS), which are aimed at providing benefits for humans, including addressing emotional, mental and social components of functioning. In recent years, the use of EAS has grown rapidly in Europe and the United States in general and is being increasingly used for active-duty military and veteran Veteran populations. As we have previously reviewed, there is evidence that EAS, such as EAL, can contribute to reduction of PTSD and other psychological symptoms as well as enhancing well-being via improvements in resilience, life satisfaction, trust, self-image, and self-control, as well as quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: May 11, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• referred to PTSD team

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Warrior Renew
Warrior Renew is a program for military sexual trauma (MST).
• Warrior Renew + EAL
Warrior Renew and EAL are combined into one program for military sexual trauma (MST).

Locations

Country	Name	City	State
United States	VA Salt Lake City Health Care System	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (17)

Arnon S, Fisher PW, Pickover A, Lowell A, Turner JB, Hilburn A, Jacob-McVey J, Malajian BE, Farber DG, Hamilton JF, Hamilton A, Markowitz JC, Neria Y. Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. Mil Med. 20 — View Citation

Bachi K, Terkel J, Teichman M. Equine-facilitated psychotherapy for at-risk adolescents: the influence on self-image, self-control and trust. Clin Child Psychol Psychiatry. 2012 Apr;17(2):298-312. doi: 10.1177/1359104511404177. Epub 2011 Jul 14. — View Citation

Burton LE, Qeadan F, Burge MR. Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. J Integr Med. 2019 Jan;17(1):14-19. doi: 10.1016/j.joim.2018.11.001. Epub 2018 Nov 16. — View Citation

Cerulli C, Minganti C, De Santis C, Tranchita E, Quaranta F, Parisi A. Therapeutic horseback riding in breast cancer survivors: a pilot study. J Altern Complement Med. 2014 Aug;20(8):623-9. doi: 10.1089/acm.2014.0061. Epub 2014 Jun 25. — View Citation

Duncan CR, Critchley S, & Marland J. Can Praxis: A model of equine assisted learning (EAL) for PTSD. Canadian Military Journal. 2014; 14(2):64-69.

Ferruolo DM. Psychosocial Equine Program for Veterans. Soc Work. 2016 Jan;61(1):53-60. doi: 10.1093/sw/swv054. — View Citation

Fields B, Bruemmer J, Gloeckner G, Wood W. Influence of an Equine-Assisted Activities Program on Dementia-Specific Quality of Life. Am J Alzheimers Dis Other Demen. 2018 Aug;33(5):309-317. doi: 10.1177/1533317518772052. Epub 2018 May 9. — View Citation

Johnson RA, Albright DL, Marzolf JR, Bibbo JL, Yaglom HD, Crowder SM, Carlisle GK, Willard A, Russell CL, Grindler K, Osterlind S, Wassman M, Harms N. Effects of therapeutic horseback riding on post-traumatic stress disorder in military veterans. Mil Med — View Citation

Lanning BA, Krenek N. Guest Editorial: Examining effects of equine-assisted activities to help combat veterans improve quality of life. J Rehabil Res Dev. 2013;50(8):vii-xiii. doi: 10.1682/JRRD.2013.07.0159. No abstract available. — View Citation

Lanning BA, Wilson AL, Krenek N, & Beaujean AA. Using therapeutic riding as an intervention for combat Veterans: An international classification of functioning, disability, and health (ICF) approach. Occupational Therapy in Mental Health. 2017; 33(3):259-

Malinowski K, Yee C, Tevlin JM, Birks EK, Durando MM, Pournajafi-Nazarloo H, Cavaiola AA, McKeever KH. The Effects of Equine Assisted Therapy on Plasma Cortisol and Oxytocin Concentrations and Heart Rate Variability in Horses and Measures of Symptoms of P — View Citation

Marchand WR, Andersen SJ, Smith JE, Hoopes KH, Carlson JK. Equine-Assisted Activities and Therapies for Veterans With Posttraumatic Stress Disorder: Current State, Challenges and Future Directions. Chronic Stress (Thousand Oaks). 2021 Feb 15;5:24705470219 — View Citation

Shelef A, Brafman D, Rosing T, Weizman A, Stryjer R, Barak Y. Equine Assisted Therapy for Patients with Post Traumatic Stress Disorder: A Case Series Study. Mil Med. 2019 Oct 1;184(9-10):394-399. doi: 10.1093/milmed/usz036. — View Citation

Steele E, Wood DS, J Usadi E, Applegarth DM. TRR's Warrior Camp: An Intensive Treatment Program for Combat Trauma in Active Military and Veterans of All Eras. Mil Med. 2018 Mar 1;183(suppl_1):403-407. doi: 10.1093/milmed/usx153. — View Citation

Sylvia L, West E, Blackburn AM, Gupta C, Bui E, Mahoney T, Duncan G, Wright EC, Lejeune S, Spencer TJ. Acceptability of an adjunct equine-assisted activities and therapies program for veterans with posttraumatic stress disorder and/or traumatic brain inju — View Citation

U.S. Congress. House Report 114-102: National Defense Authorization Act for Fiscal Year 2016; 2015. https://www.congress.gov/congressional-report/114th-congress/house-report/102/1

Wharton T, Whitworth J, Macauley E, Malone M. Pilot testing a manualized equine-facilitated cognitive processing therapy (EF-CPT) intervention for PTSD in veterans. Psychiatr Rehabil J. 2019 Sep;42(3):268-276. doi: 10.1037/prj0000359. Epub 2019 Mar 25. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PCL Measures Pre to Post-Intervention and by Intervention Type	The Posttraumatic Checklist-5 (PCL) was used to assess self-reported symptoms of PTSD using items consistent with the Diagnostic and Statistical Manual - Fifth Edition. PCL-5 scores can range from 0 to 80 with higher score indicating more PTSD symptoms.	through study completion, an average of 2 years
Primary	Change in PHQ Measures Pre to Post-Intervention and by Intervention Type	The Patient Health Questionnaire (PHQ) was used to assess symptoms of major depression. PHQ scores range from 0 to 27 with higher scores indicating greater depression symptoms.	through study completion, an average of 2 years
Primary	Change in PTCI Measures Pre to Post-Intervention and by Intervention Type	The Posttraumatic Cognitions Inventory (PTCI) was used to assess trauma-related thoughts and beliefs. PTCI can range from 33-252 with higher scores indicating more distress.	through study completion, an average of 2 years
Primary	Mean and Standard Deviation of Demographic information by Intervention Type	The demographic information analyzed includes age, sex, race, ethnicity, religion, service era, service connection, service connection percentage, diagnoses, Emergency Department (ED) visits, Inpatient Psychiatric Unit (IPU) visits, Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) visits.	through study completion, an average of 2 years