<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039361</url>
  </required_header>
  <id_info>
    <org_study_id>13-547</org_study_id>
    <nct_id>NCT03039361</nct_id>
  </id_info>
  <brief_title>Equine Assisted Psychotherapy for PTSD</brief_title>
  <official_title>Equine Assisted Psychotherapy for PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD&#xD;
      symptoms in veterans with PTSD as compared with existing care.&#xD;
&#xD;
      The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms&#xD;
      following participation in a 6-week Equine Assisted Psychotherapy program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will employ a randomized, parallel group design with delayed intervention in the&#xD;
      control group. Eligible participants will be randomly assigned using a random number&#xD;
      generator. The PTSD Checklist (PCL) - Military (measuring PTSD symptoms) will be administered&#xD;
      to each participant at week 0 and week 6. Permissions have been obtained for the use of the&#xD;
      survey.&#xD;
&#xD;
      Surveys will be identified by randomized number only, to maintain confidentiality.&#xD;
      Participants will be assigned a unique identifier. A list of participant's initials and their&#xD;
      random assigned numbers will be kept in a locked secure file by the investigator. In this way&#xD;
      the participants confidentially will be protected.&#xD;
&#xD;
      The participants assigned to the intervention group will complete the Equine Assisted&#xD;
      Psychotherapy (EAP) program that will be performed at an Equine Assisted Growth and Learning&#xD;
      Association (EAGALA) certified facility. The participants will be going through a 6 week&#xD;
      program. The researcher will not be conducting the therapy. An EAGALA certified and licensed&#xD;
      Occupational Therapist will be running the therapy as well as a professional Horse Handler&#xD;
      for safety. In the event that a participant is in need of additional therapy as a result of&#xD;
      this research, a psychotherapist will be on call. Participation will not include riding the&#xD;
      horses. &quot;The basis of the EAGALA Model is a belief that all clients have the best solutions&#xD;
      for themselves when given the opportunity to discover them. Rather than instructing or&#xD;
      directing solutions, [the instructor] allow [their] clients to experiment, problem-solve,&#xD;
      take risks, employ creativity, and find their own solutions that work best for them. No&#xD;
      horseback riding is involved. Instead, effective and deliberate techniques are utilized where&#xD;
      the horses are metaphors in specific ground-based experiences.&quot;&#xD;
      (http://www.eagala.org/Information/What_Is_EAGALA_Model) All horse based activities involve&#xD;
      inherent risk. The facility and the horses that the participants will be using are used daily&#xD;
      for Hippotherapy involving disabled individuals. All safety procedures and precautions&#xD;
      outlined by the EAGALA certifications and the therapy facility will be strictly maintained.&#xD;
      The participants may decline to do any of the therapy activities and or survey questions at&#xD;
      any time. If the certified therapist senses a problem, they will stop the therapy and consult&#xD;
      with a psychotherapist.&#xD;
&#xD;
      The participants assigned to the control group will have no intervention related to the&#xD;
      research but may continue any preexisting therapy. They will be asked to not initiate any new&#xD;
      therapy programs. The participants will be however given the option of delayed EAP after the&#xD;
      completion of the 6 week program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 17-item PCL-Military (PTSD Symptoms)</measure>
    <time_frame>Baseline and 6 weeks</time_frame>
    <description>A validated and widely used survey instrument to assess PTSD symptoms for the purposes of diagnosis, clinical assessment, and scientific inquiry. Scores range from 17 to 85 in severity, with anything over 29 as having PTSD.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>PostTraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Equine Assisted Psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 week Equine Assisted Psychotherapy program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care, Existing PTSD therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Equine Assisted Psychotherapy</intervention_name>
    <description>Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.</description>
    <arm_group_label>Equine Assisted Psychotherapy</arm_group_label>
    <other_name>Equine Assisted Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will include war veterans with post-traumatic stress disorder, who have a&#xD;
             PCL-M symptom score of ≥ 29 with an age between 18 and 75.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent, individuals aged &lt; 18 years, individuals receiving&#xD;
             antipsychotic medication, individuals receiving glucocorticoid therapy, and/or&#xD;
             pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark R Burge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNM Clinical Translational Science Center</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will be provided in Lobo vault after finalization of the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039361
org study id: 13-547
nct id: NCT03039361
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD
      symptoms in veterans with PTSD as compared with existing care.

      The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms
      following participation in a 6-week Equine Assisted Psychotherapy program.
This study will employ a randomized, parallel group design with delayed intervention in the
      control group. Eligible participants will be randomly assigned using a random number
      generator. The PTSD Checklist (PCL) - Military (measuring PTSD symptoms) will be administered
      to each participant at week 0 and week 6. Permissions have been obtained for the use of the
      survey.

      Surveys will be identified by randomized number only, to maintain confidentiality.
      Participants will be assigned a unique identifier. A list of participant's initials and their
      random assigned numbers will be kept in a locked secure file by the investigator. In this way
      the participants confidentially will be protected.

      The participants assigned to the intervention group will complete the Equine Assisted
      Psychotherapy (EAP) program that will be performed at an Equine Assisted Growth and Learning
      Association (EAGALA) certified facility. The participants will be going through a 6 week
      program. The researcher will not be conducting the therapy. An EAGALA certified and licensed
      Occupational Therapist will be running the therapy as well as a professional Horse Handler
      for safety. In the event that a participant is in need of additional therapy as a result of
      this research, a psychotherapist will be on call. Participation will not include riding the
      horses. "The basis of the EAGALA Model is a belief that all clients have the best solutions
      for themselves when given the opportunity to discover them. Rather than instructing or
      directing solutions, [the instructor] allow [their] clients to experiment, problem-solve,
      take risks, employ creativity, and find their own solutions that work best for them. No
      horseback riding is involved. Instead, effective and deliberate techniques are utilized where
      the horses are metaphors in specific ground-based experiences."
      (http://www.eagala.org/Information/What_Is_EAGALA_Model) All horse based activities involve
      inherent risk. The facility and the horses that the participants will be using are used daily
      for Hippotherapy involving disabled individuals. All safety procedures and precautions
      outlined by the EAGALA certifications and the therapy facility will be strictly maintained.
      The participants may decline to do any of the therapy activities and or survey questions at
      any time. If the certified therapist senses a problem, they will stop the therapy and consult
      with a psychotherapist.

      The participants assigned to the control group will have no intervention related to the
      research but may continue any preexisting therapy. They will be asked to not initiate any new
      therapy programs. The participants will be however given the option of delayed EAP after the
      completion of the 6 week program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in 17-item PCL-Military (PTSD Symptoms)
time frame: Baseline and 6 weeks
description: A validated and widely used survey instrument to assess PTSD symptoms for the purposes of diagnosis, clinical assessment, and scientific inquiry. Scores range from 17 to 85 in severity, with anything over 29 as having PTSD.
arm group label: Equine Assisted Psychotherapy
arm group type: Experimental
description: 6 week Equine Assisted Psychotherapy program
arm group label: Control
arm group type: No Intervention
description: Standard of Care, Existing PTSD therapy
intervention type: Behavioral
intervention name: Equine Assisted Psychotherapy
description: Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.
arm group label: Equine Assisted Psychotherapy
other name: Equine Assisted Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark R Burge, MD
role: Principal Investigator
affiliation: UNM Clinical Translational Science Center
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
ipd description: Individual participant data will be provided in Lobo vault after finalization of the study.