Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
equine assisted activities
Sponsored by
About this trial
This is an interventional basic science trial for Stress Disorders, Post-Traumatic focused on measuring veterans, equine
Eligibility Criteria
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
Sites / Locations
- Rutgers Equine Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EAA
Control
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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 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 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 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 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 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.
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.
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.
Changes in resting heart rate following 8 weeks of EAA
Telemetric heart rate monitors will be used to collect resting heart rate.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04850573
First Posted
April 14, 2021
Last Updated
June 29, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04850573
Brief Title
Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
Official Title
Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
veterans, equine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EAA
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
equine assisted activities
Other Intervention Name(s)
equine facilitated learning, horsemanship
Intervention Description
Participants interact with the horse and learn how to safely handle the horse.
Primary Outcome Measure Information:
Title
Change from Baseline to the Conclusion of 8 weeks of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
Description
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.
Time Frame
Symptoms will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Change from Baseline to 2-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
Description
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.
Time Frame
Symptoms will be assessed prior to the intervention and 2-months after the end of the EAA sessions.
Title
Change from Baseline to 6-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
Description
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.
Time Frame
Symptoms will be assessed prior to the intervention and 6-months after the end of the EAA sessions.
Title
Co-regulation of heart rate between horse and human during EAA sessions.
Description
Co-regulation will be assessed through the telemetric measurement and modeling of heart rate.
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..
Title
Co-regulation of cortisol between horse and human during EAA sessions.
Description
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma cortisol.
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.
Title
Co-regulation of oxytocin between horse and human during EAA sessions.
Description
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma oxytocin.
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.
Title
Co-regulation of epinephrine between horse and human during EAA sessions.
Description
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma epinephrine.
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.
Title
Co-regulation of norepinephrine between horse and human during EAA sessions.
Description
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma norepinephrine.
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.
Title
Co-regulation of muscle activity between horse and human during EAA sessions.
Description
Co-regulation will be assessed through collection of surface electromyography (sEMG) from the masseter, brachiocephalas, and cervical trapezius muscles and subsequent modeling.
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.
Title
Changes in co-regulation of heart rate during dyadic (human-human) interactions following 8 weeks of EAA
Description
Co-regulation will be assessed through the measurement and modeling of heart rate during gazing, not looking, resting, and mimicking tasks.
Time Frame
Co-regulation will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Changes in social motor synchrony during dyadic (human-human) interactions following 8 weeks of EAA
Description
Social motor synchrony will be assessed through the measurement and modeling of gross motor movement during a pendulum swinging task.
Time Frame
Social motor synchrony will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Changes in resting heart rate following 8 weeks of EAA
Description
Telemetric heart rate monitors will be used to collect resting heart rate.
Time Frame
Resting heart rate will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Changes in basal plasma cortisol concentration following 8 weeks of EAA
Description
Plasma concentrations of cortisol will be measured via immunoassay following blood draws during rest.
Time Frame
Cortisol concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Changes in plasma basal oxytocin concentration following 8 weeks of EAA
Description
Plasma concentrations of oxytocin will be measured via immunoassay following blood draws during rest.
Time Frame
Plasma oxytocin concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Changes in basal plasma epinephrine concentration following 8 weeks of EAA
Description
Plasma concentrations of epinephrine will be measured via immunoassay following blood draws during rest.
Time Frame
Plasma epinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Title
Changes in basal plasma norepinephrine concentration following 8 weeks of EAA
Description
Plasma concentrations of norepinephrine will be measured via immunoassay following blood draws during rest.
Time Frame
Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only males are eligible for inclusion in the study because the hormones being measured are impacted by the menstrual cycle in females.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karyn Malinowski, Ph.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Equine Science Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
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