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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04850573
Enrollment
9
Registered
2021-04-20
Start date
2021-06-21
Completion date
2023-06-16
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

veterans, equine

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.

Interventions

OTHERequine assisted activities

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

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline to the Conclusion of 8 weeks of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom InventorySymptoms 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.
Change from Baseline to 2-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom InventorySymptoms 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.
Change from Baseline to 6-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom InventorySymptoms 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.
Co-regulation of heart rate between horse and human during EAA sessions.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.
Co-regulation of cortisol between horse and human during EAA sessions.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.
Co-regulation of oxytocin between horse and human during EAA sessions.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.
Co-regulation of epinephrine between horse and human during EAA sessions.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.
Co-regulation of norepinephrine between horse and human during EAA sessions.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.
Co-regulation of muscle activity between horse and human during EAA sessions.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.
Changes in co-regulation of heart rate during dyadic (human-human) interactions following 8 weeks of EAACo-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.
Changes in social motor synchrony during dyadic (human-human) interactions following 8 weeks of EAASocial 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.
Changes in resting heart rate following 8 weeks of EAAResting 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.
Changes in basal plasma cortisol concentration following 8 weeks of EAACortisol 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.
Changes in plasma basal oxytocin concentration following 8 weeks of EAAPlasma 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.
Changes in basal plasma epinephrine concentration following 8 weeks of EAAPlasma 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.
Changes in basal plasma norepinephrine concentration following 8 weeks of EAAPlasma 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026