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PTSDNCT05422768

PTSD Clinical Team Research Clinic (PCT Research Clinic)

An observational study of PTSD, run by VA Salt Lake City Health Care System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD
What is being tested?
Warrior Renew and Warrior Renew + EAL
How many people
118 participants
Where
1 siteUnited States
Study dates
16 Nov 2020to 11 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • referred to PTSD team

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Salt Lake City Health Care System

    Salt Lake City, Utah, 84148

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions
PTSD
Being tested
Warrior Renew, Warrior Renew + EAL
Keywords
PTSD
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Warrior RenewBehavioural

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

  • Warrior Renew + EALBehavioural

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

Study groups in NCT05422768
Study groupRoleWhat they receive
Warrior RenewWarrior Renew is a program for military sexual trauma (MST).
Receives: Behavioral: Warrior Renew
Warrior Renew + EALWarrior Renew and EAL are combined into one program for military sexual trauma (MST).
Receives: Behavioral: Warrior Renew + EAL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 2 years

  2. 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.

    Measured: through study completion, an average of 2 years

  3. 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.

    Measured: through study completion, an average of 2 years

  4. 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.

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start16 Nov 2020
  3. Primary completion11 May 2024 (estimated)
  4. Study completion11 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05422768
Sponsor's protocol ID
IRB_00136053
Status last verified
May 2023
First submitted
16 Feb 2022
Last updated
12 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • 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.

    PubMed 21757481

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

    PubMed 26897999

  • 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.

    PubMed 32034416

  • 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.

    PubMed 33644617

  • 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.

    PubMed 30839068

  • 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.

    PubMed 30497951

  • 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.

    PubMed 30973147

  • 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.

    PubMed 29502529

  • 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.

    PubMed 29635563

  • 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.

  • 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.

    PubMed 24458903

  • 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

  • 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.

    PubMed 31996299

  • 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.

    PubMed 30907609

Questions about this trial

What is this clinical trial studying?

An observational study of PTSD, run by VA Salt Lake City Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PCL Measures Pre to Post-Intervention and by Intervention Type (time frame: through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05422768, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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