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Completed

NCT Number: NCT04850573

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Equine Science Center

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

equine assisted activities

Other

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

Other names: equine facilitated learning, horsemanship

Primary outcomes

  1. Change from Baseline to the Conclusion of 8 weeks of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory

    Time frame: Symptoms will be assessed prior to the intervention and immediately following the eight week intervention.

    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.

  2. Change from Baseline to 2-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory

    Time frame: Symptoms will be assessed prior to the intervention and 2-months after the end of the EAA sessions.

    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.

  3. Change from Baseline to 6-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory

    Time frame: Symptoms will be assessed prior to the intervention and 6-months after the end of the EAA sessions.

    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.

  4. Co-regulation of heart rate between horse and human during EAA sessions.

    Time frame: 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 will be assessed through the telemetric measurement and modeling of heart rate.

  5. Co-regulation of cortisol between horse and human during EAA sessions.

    Time frame: 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 will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma cortisol.

  6. Co-regulation of oxytocin between horse and human during EAA sessions.

    Time frame: 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 will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma oxytocin.

  7. Co-regulation of epinephrine between horse and human during EAA sessions.

    Time frame: 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 will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma epinephrine.

  8. Co-regulation of norepinephrine between horse and human during EAA sessions.

    Time frame: 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 will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma norepinephrine.

  9. Co-regulation of muscle activity between horse and human during EAA sessions.

    Time frame: 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.

    Co-regulation will be assessed through collection of surface electromyography (sEMG) from the masseter, brachiocephalas, and cervical trapezius muscles and subsequent modeling.

  10. Changes in co-regulation of heart rate during dyadic (human-human) interactions following 8 weeks of EAA

    Time frame: Co-regulation will be assessed prior to the intervention and immediately following the eight week intervention.

    Co-regulation will be assessed through the measurement and modeling of heart rate during gazing, not looking, resting, and mimicking tasks.

  11. Changes in social motor synchrony during dyadic (human-human) interactions following 8 weeks of EAA

    Time frame: Social motor synchrony will be assessed prior to the intervention and immediately following the eight week intervention.

    Social motor synchrony will be assessed through the measurement and modeling of gross motor movement during a pendulum swinging task.

  12. Changes in resting heart rate following 8 weeks of EAA

    Time frame: Resting heart rate will be assessed prior to the intervention and immediately following the eight week intervention.

    Telemetric heart rate monitors will be used to collect resting heart rate.

  13. Changes in basal plasma cortisol concentration following 8 weeks of EAA

    Time frame: Cortisol concentrations will be assessed prior to the intervention and immediately following the eight week intervention.

    Plasma concentrations of cortisol will be measured via immunoassay following blood draws during rest.

  14. Changes in plasma basal oxytocin concentration following 8 weeks of EAA

    Time frame: Plasma oxytocin concentrations will be assessed prior to the intervention and immediately following the eight week intervention.

    Plasma concentrations of oxytocin will be measured via immunoassay following blood draws during rest.

  15. Changes in basal plasma epinephrine concentration following 8 weeks of EAA

    Time frame: Plasma epinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.

    Plasma concentrations of epinephrine will be measured via immunoassay following blood draws during rest.

  16. Changes in basal plasma norepinephrine concentration following 8 weeks of EAA

    Time frame: Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.

    Plasma concentrations of norepinephrine will be measured via immunoassay following blood draws during rest.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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