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

NCT04850573 | Completed

• 1 other identifier: Pro2019001999
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

veterans, equine

Outcome Measures

Primary Outcomes (16)

• 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.

Study Arms (2)

EAA

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

equine assisted activities OTHER

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

Also known as: equine facilitated learning, horsemanship

EAA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only males are eligible for inclusion in the study because the hormones being measured are impacted by the menstrual cycle in females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Equine Science Center

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• 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.

  PMID: 38863605 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Karyn Malinowski, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Rutgers Equine Science Center

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: June 21, 2021
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)