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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850573
• Other study ID #: Pro2019001999
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: June 16, 2023

Study information

• Verified date: June 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• equine assisted activities
Participants interact with the horse and learn how to safely handle the horse.

Locations

Country	Name	City	State
United States	Rutgers Equine Science Center	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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..
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.