NCT05422768

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 16, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2024

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

February 16, 2022

Last Update Submit

May 10, 2023

Conditions

PTSD

Keywords

PTSD

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Warrior Renew

Warrior Renew is a program for military sexual trauma (MST).

Behavioral: Warrior Renew

Warrior Renew + EAL

Warrior Renew and EAL are combined into one program for military sexual trauma (MST).

Behavioral: Warrior Renew + EAL

Interventions

Warrior RenewBEHAVIORAL

Warrior Renew is a program for military sexual trauma (MST).

Warrior Renew
Warrior Renew + EALBEHAVIORAL

Warrior Renew and EAL are combined into one program for military sexual trauma (MST).

Warrior Renew + EAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Veterans who were referred to PTSD team were contacted to see if they wanted to participate in the study.

You may qualify if:

  • referred to PTSD team

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

Location

Related Publications (17)

  • 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

    RESULT

  • 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.

    PMID: 21757481RESULT

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

    PMID: 26897999RESULT

  • 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. 2020 Jun 8;185(5-6):e557-e564. doi: 10.1093/milmed/usz444.

    PMID: 32034416RESULT

  • 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;5:2470547021991556. doi: 10.1177/2470547021991556. eCollection 2021 Jan-Dec.

    PMID: 33644617RESULT

  • 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.

    PMID: 30839068RESULT

  • 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.

    PMID: 30497951RESULT

  • 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 Post-Traumatic Stress Disorder in Veterans. J Equine Vet Sci. 2018 May;64:17-26. doi: 10.1016/j.jevs.2018.01.011. Epub 2018 Feb 12.

    PMID: 30973147RESULT

  • 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 Res. 2018 Jan 19;5(1):3. doi: 10.1186/s40779-018-0149-6.

    PMID: 29502529RESULT

  • 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.

    PMID: 29635563RESULT

  • 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.

    RESULT

  • 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.

    PMID: 24458903RESULT

  • 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):259-278. https://doi.org/10.1080/0164212X.2017.1283282

    RESULT

  • 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 injury. J Integr Med. 2020 Mar;18(2):169-173. doi: 10.1016/j.joim.2020.01.005. Epub 2020 Jan 21.

    PMID: 31996299RESULT

  • 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.

    PMID: 30907609RESULT

  • 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.

    PMID: 24963599RESULT

  • 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.

    PMID: 29742908RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Erika Roberge, PhD

    Salt Lake City Veterans' Administration Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

June 16, 2022

Study Start

November 16, 2020

Primary Completion

May 11, 2024

Study Completion

May 11, 2024

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

US(1)