Clinical trial NCT04850573: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: veterans, equine
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change from Baseline to the Conclusion of 8 weeks of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
timeFrame: Symptoms will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Change from Baseline to 2-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
timeFrame: Symptoms will be assessed prior to the intervention and 2-months after the end of the EAA sessions.
measure: Change from Baseline to 6-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
timeFrame: Symptoms will be assessed prior to the intervention and 6-months after the end of the EAA sessions.
measure: Co-regulation of heart rate between horse and human during EAA sessions.
timeFrame: Co-regulation of heart rate between horse and human will be assessed once a week during a 30 min session for 8 weeks..
measure: Co-regulation of cortisol between horse and human during EAA sessions.
timeFrame: 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.
measure: Co-regulation of oxytocin between horse and human during EAA sessions.
timeFrame: 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.
measure: Co-regulation of epinephrine between horse and human during EAA sessions.
timeFrame: 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.
measure: Co-regulation of norepinephrine between horse and human during EAA sessions.
timeFrame: 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.
measure: Co-regulation of muscle activity between horse and human during EAA sessions.
timeFrame: 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.
measure: Changes in co-regulation of heart rate during dyadic (human-human) interactions following 8 weeks of EAA
timeFrame: Co-regulation will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Changes in social motor synchrony during dyadic (human-human) interactions following 8 weeks of EAA
timeFrame: Social motor synchrony will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Changes in resting heart rate following 8 weeks of EAA
timeFrame: Resting heart rate will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Changes in basal plasma cortisol concentration following 8 weeks of EAA
timeFrame: Cortisol concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Changes in plasma basal oxytocin concentration following 8 weeks of EAA
timeFrame: Plasma oxytocin concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Changes in basal plasma epinephrine concentration following 8 weeks of EAA
timeFrame: Plasma epinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
measure: Changes in basal plasma norepinephrine concentration following 8 weeks of EAA
timeFrame: Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Equine Science Center
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Karyn Malinowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: