NCT03039361

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

January 11, 2017

Last Update Submit

March 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in 17-item PCL-Military (PTSD Symptoms)

    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.

    Baseline and 6 weeks

Study Arms (2)

Equine Assisted Psychotherapy

EXPERIMENTAL

6 week Equine Assisted Psychotherapy program

Behavioral: Equine Assisted Psychotherapy

Control

NO INTERVENTION

Standard of Care, Existing PTSD therapy

Interventions

Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.

Also known as: Equine Assisted Therapy
Equine Assisted Psychotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will include war veterans with post-traumatic stress disorder, who have a PCL-M symptom score of ≥ 29 with an age between 18 and 75.

You may not qualify if:

  • Adults unable to consent, individuals aged \< 18 years, individuals receiving antipsychotic medication, individuals receiving glucocorticoid therapy, and/or pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mark R Burge, MD

    UNM Clinical Translational Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

February 1, 2017

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will be provided in Lobo vault after finalization of the study.