PTSD Clinical Team Research Clinic (PCT Research Clinic)

May 10, 2023 updated by: VA Salt Lake City Health Care System
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • referred to PTSD team

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Warrior Renew
Warrior Renew is a program for military sexual trauma (MST).
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).
Behavioral: Warrior Renew + EAL
Warrior Renew and EAL are combined into one program for military sexual trauma (MST).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PCL Measures Pre to Post-Intervention and by Intervention Type
Time Frame: through study completion, an average of 2 years
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
Time Frame: through study completion, an average of 2 years
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
Time Frame: through study completion, an average of 2 years
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
Time Frame: through study completion, an average of 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Salt Lake City Health Care System

Investigators

  • Principal Investigator: Erika Roberge, PhD, Salt Lake City Veterans' Administration Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Anticipated)

May 11, 2024

Study Completion (Anticipated)

May 11, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00136053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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