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

June 29, 2023 updated by: Karyn Malinowski, Ph.D., Rutgers, The State University of New Jersey
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Equine Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: EAA
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.
Other: equine assisted activities
Participants interact with the horse and learn how to safely handle the horse.
Other Names:
  • equine facilitated learning, horsemanship

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Symptoms will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Symptoms will be assessed prior to the intervention and 2-months after the end of the EAA sessions.
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.
Symptoms will be assessed prior to the intervention and 6-months after the end of the EAA sessions.
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.
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 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.
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 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.
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 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.
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 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.
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 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.
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.
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.
Co-regulation will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Social motor synchrony will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Resting heart rate will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Cortisol concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Plasma oxytocin concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Plasma epinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
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.
Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karyn Malinowski, Ph.D., Rutgers, The State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2019001999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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