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

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: equine assisted activities

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karyn Malinowski, Ph.D.; Phone Number: +1 848-932-9419; Email: karynmal@njaes.rutgers.edu
• Study Contact Backup: Name: Ellen M Rankins, M.S.; Phone Number: +1 848-932-3761; Email: ellen.rankins@rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Equine Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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.	Other: equine assisted activities; Participants interact with the horse and learn how to safely handle the horse.; Other Names: equine facilitated learning, horsemanship

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to the Conclusion of 8 weeks of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory	The Brief Symptom Inventory and PTSD Checklist for DSM-5 are questionnaires used to assess the presence and severity of post-traumatic stress disorder symptoms.	Symptoms will be assessed prior to the intervention and immediately following the eight week intervention.
Change from Baseline to 2-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory	The Brief Symptom Inventory and PTSD Checklist for DSM-5 are questionnaires used to assess the presence and severity of post-traumatic stress disorder symptoms.	Symptoms will be assessed prior to the intervention and 2-months after the end of the EAA sessions.
Change from Baseline to 6-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory	The Brief Symptom Inventory and PTSD Checklist for DSM-5 are questionnaires used to assess the presence and severity of post-traumatic stress disorder symptoms.	Symptoms will be assessed prior to the intervention and 6-months after the end of the EAA sessions.
Co-regulation of heart rate between horse and human during EAA sessions.	Co-regulation will be assessed through the telemetric measurement and modeling of heart rate.	Co-regulation of heart rate between horse and human will be assessed once a week during a 30 min session for 8 weeks..
Co-regulation of cortisol between horse and human during EAA sessions.	Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma cortisol.	Co-regulation of cortisol between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation of oxytocin between horse and human during EAA sessions.	Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma oxytocin.	Co-regulation of oxytocin between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation of epinephrine between horse and human during EAA sessions.	Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma epinephrine.	Co-regulation of epinephrine between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation of norepinephrine between horse and human during EAA sessions.	Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma norepinephrine.	Co-regulation of norepinephrine between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation of muscle activity between horse and human during EAA sessions.	Co-regulation will be assessed through collection of surface electromyography (sEMG) from the masseter, brachiocephalas, and cervical trapezius muscles and subsequent modeling.	Co-regulation of muscle activity between horse and human will be assessed once a week during a 30 min session over an 8 week period.
Changes in co-regulation of heart rate during dyadic (human-human) interactions following 8 weeks of EAA	Co-regulation will be assessed through the measurement and modeling of heart rate during gazing, not looking, resting, and mimicking tasks.	Co-regulation will be assessed prior to the intervention and immediately following the eight week intervention.
Changes in social motor synchrony during dyadic (human-human) interactions following 8 weeks of EAA	Social motor synchrony will be assessed through the measurement and modeling of gross motor movement during a pendulum swinging task.	Social motor synchrony will be assessed prior to the intervention and immediately following the eight week intervention.
Changes in resting heart rate following 8 weeks of EAA	Telemetric heart rate monitors will be used to collect resting heart rate.	Resting heart rate will be assessed prior to the intervention and immediately following the eight week intervention.
Changes in basal plasma cortisol concentration following 8 weeks of EAA	Plasma concentrations of cortisol will be measured via immunoassay following blood draws during rest.	Cortisol concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Changes in plasma basal oxytocin concentration following 8 weeks of EAA	Plasma concentrations of oxytocin will be measured via immunoassay following blood draws during rest.	Plasma oxytocin concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Changes in basal plasma epinephrine concentration following 8 weeks of EAA	Plasma concentrations of epinephrine will be measured via immunoassay following blood draws during rest.	Plasma epinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Changes in basal plasma norepinephrine concentration following 8 weeks of EAA	Plasma concentrations of norepinephrine will be measured via immunoassay following blood draws during rest.	Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Karyn Malinowski, Ph.D., Rutgers, the State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: veterans, equine
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Pro2019001999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No