Stress Disorders, Post-TraumaticNCT04850573
Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
A study testing equine assisted activities in people with Stress Disorders, Post-Traumatic, run by Rutgers, The State University of New Jersey at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- equine assisted activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 16 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- was deployed and experienced combat in Iraq or Afghanistan
- between 18 and 65 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Equine Science Center
New Brunswick, New Jersey, 08901
About this study
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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- equine assisted activities
- Keywords
- veterans, equine
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
equine assisted activitiesOther
Also called equine facilitated learning, horsemanship
Participants interact with the horse and learn how to safely handle the horse.
| Study group | Role | What they receive |
|---|---|---|
| EAA | Experimental | 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. Receives: Other: equine assisted activities |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Co-regulation will be assessed through the telemetric measurement and modeling of heart rate.
Measured: 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.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma cortisol.
Measured: 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.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma oxytocin.
Measured: 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.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma epinephrine.
Measured: 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.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma norepinephrine.
Measured: 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.
Co-regulation will be assessed through collection of surface electromyography (sEMG) from the masseter, brachiocephalas, and cervical trapezius muscles and subsequent modeling.
Measured: 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
Co-regulation will be assessed through the measurement and modeling of heart rate during gazing, not looking, resting, and mimicking tasks.
Measured: 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
Social motor synchrony will be assessed through the measurement and modeling of gross motor movement during a pendulum swinging task.
Measured: 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
Telemetric heart rate monitors will be used to collect resting heart rate.
Measured: 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
Plasma concentrations of cortisol will be measured via immunoassay following blood draws during rest.
Measured: 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
Plasma concentrations of oxytocin will be measured via immunoassay following blood draws during rest.
Measured: 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
Plasma concentrations of epinephrine will be measured via immunoassay following blood draws during rest.
Measured: 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
Plasma concentrations of norepinephrine will be measured via immunoassay following blood draws during rest.
Measured: Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start21 Jun 2021
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karyn Malinowski, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Karyn Malinowski, Ph.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850573
- Sponsor's protocol ID
- Pro2019001999
- Status last verified
- Jun 2023
- First submitted
- 14 Apr 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rankins EM, Quinn A, McKeever KH, Malinowski K. Ground-based adaptive horsemanship lessons for veterans with post-traumatic stress disorder: a randomized controlled pilot study. Front Psychiatry. 2024 May 28;15:1390212. doi: 10.3389/fpsyt.2024.1390212. eCollection 2024.
PubMed 38863605
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04850573
- Acronym / sponsor ID
- Pro2019001999
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- veterans, equine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EAA | Experimental | Other: equine assisted activitiesParticipants 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male
- was deployed and experienced combat in Iraq or Afghanistan
- between 18 and 65 years of age
Key exclusion criteria (7 listed)
- female
- amputation
- severe traumatic brain injury
- schizophrenia, bi-polar disorder, or substance dependence in the last 3 months
- pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| equine assisted activitiesAlso: equine facilitated learning, horsemanshipParticipants interact with the horse and learn how to safely handle the horse. | Other | EAA |
Primary outcome
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.
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.
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.
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 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 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 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 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 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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 38863605Rankins EM, Quinn A, McKeever KH, Malinowski K. Ground-based adaptive horsemanship lessons for veterans with post-traumatic stress disorder: a randomized controlled pilot study. Front Psychiatry. 2024 May 28;15:1390212. doi: 10.3389/fpsyt.2024.1390212. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karyn Malinowski, Ph.D. principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing equine assisted activities in people with Stress Disorders, Post-Traumatic, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.