Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder

NCT ID: NCT04850573

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2023-06-16

Brief Summary

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The study will examine the effects of eight weeks of equine assisted activities (EAA) on co-regulation, basal physiological values, and symptom severity in veterans with post-traumatic stress disorder (PTSD). Heart rate, respiration rate, surface electromyography (EMG) and plasma concentrations of cortisol, epinephrine, norepinephrine, and oxytocin will be measured at rest and during dyadic interaction tasks (human to human or human to horse) to assess effects of EAA on these measures. Additionally, standard and regularly used questionnaires will be used to monitor PTSD symptom severity during the study and 6-month follow-up period. EAA is expected to lower PTSD symptom severity, and mitigate other physiological changes associated with PTSD.

Detailed Description

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Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomly assigned to an equine assisted activities intervention or wait-listed control for eight weeks. At the end of the eight week period, participants assigned to the wait-listed control will be offered the opportunity to participate in the equine assisted activities intervention.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EAA

Participants in this arm will take part in eight weekly thirty minute sessions of equine facilitated learning where they interact with a horse and learn basic horsemanship skills.

Group Type EXPERIMENTAL

equine assisted activities

Intervention Type OTHER

Participants interact with the horse and learn how to safely handle the horse.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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equine assisted activities

Participants interact with the horse and learn how to safely handle the horse.

Intervention Type OTHER

Other Intervention Names

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equine facilitated learning, horsemanship

Eligibility Criteria

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Inclusion Criteria

* male
* was deployed and experienced combat in Iraq or Afghanistan
* between 18 and 65 years of age

Exclusion Criteria

* female
* amputation
* severe traumatic brain injury
* schizophrenia, bi-polar disorder, or substance dependence in the last 3 months
* pacemaker
* allergies to horses
* previous enrollment in equine assisted activities or psychotherapy in an equine environment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Karyn Malinowski, Ph.D.

Professor and Director, Rutgers Equine Science Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karyn Malinowski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Rutgers Equine Science Center

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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Rankins EM, Quinn A, McKeever KH, Malinowski K. Ground-based adaptive horsemanship lessons for veterans with post-traumatic stress disorder: a randomized controlled pilot study. Front Psychiatry. 2024 May 28;15:1390212. doi: 10.3389/fpsyt.2024.1390212. eCollection 2024.

Reference Type DERIVED
PMID: 38863605 (View on PubMed)

Other Identifiers

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Pro2019001999

Identifier Type: -

Identifier Source: org_study_id

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