PTSDNCT04832815
Equine Human Interaction With Veterans
A study testing Equine Therapy and Therapeutic Horsemanship Program in people with PTSD, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial summary
This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Equine Therapy and Therapeutic Horsemanship Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 19 Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Aim 1:
- Currently enrolled for services at the VA Salt Lake City Health Care System
- At least one mental health service encounter within the preceding 12 months
- Diagnosed with PTSD by a clinician within the preceding 24 months
- Have a doctor release to participate in equine activities
- For Aim 2:
- Currently enrolled for services at the VA Salt Lake City Health Care System
- Have a doctor release to participate in equine activities
Who cannot join
- Pregnancy
- Diagnoses of a psychotic spectrum illness and/or cognitive impairment
- Physical disability that would prevent horseback riding
- Weight >= 250 lbs.
- Potentially the severity of and psychological and/or behavioral symptoms will be considered
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148
About this study
This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes.
- Conditions
- PTSD
- Being tested
- Equine Therapy, Therapeutic Horsemanship Program
- Keywords
- Equine, PTSD
- 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 TherapyBehavioural
Aim 1: Six session equine interventions. Intervention will be provided one day per week for four weeks. During the first two weeks, each intervention day with consist of two sessions with a lunch break in between. Weeks four and five consist of one trail riding session per intervention day followed by lunch. Each session will be approximately 1.5 hours in length. Sessions 1-4 will occur at the USU Equine Education Center, and session 5-6 will occur on local trails. Optional transportation for participants will be provided from the VA to the intervention site.
Therapeutic Horsemanship ProgramBehavioural
Aim 2: Therapeutic Horsemanship program utilizes the USU Pathways to Horsemanship model and covers levels of equestrian training from basic groundwork to more advanced riding techniques. Training occurs in a three or six-session format with once weekly sessions over three or six weeks. Mindfulness and mindful self-compassion training may be included.
| Study group | Role | What they receive |
|---|---|---|
| Equine Therapy | Experimental | Not described Receives: Behavioral: Equine Therapy |
| Treatment as Usual (TAU) | No intervention | Not described |
| Therapeutic Horsemanship Program | Experimental | Not described Receives: Behavioral: Therapeutic Horsemanship Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
AAQII measures psychological flexibility. The total AAQII score can range from 7 to 49, with higher values indicating greater psychological inflexibility. Mixed Effect Modeling will be used for the analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome at multiple time points: pre-intervention, post-intervention for selected or all sessions, and post-intervention.
Measured: through study completion, an average of 2 years
Heart Rate (HR) Indices
To determine correlations between physiological responses of the rider and horse, the following heart rate (HR) indices will be computed: Mean HR, standard deviation of the beat-to-beat intervals (SDRR) and the root mean square of successive beat-to-beat differences (rMSSD). Both SDRR and rMSSD are measures of HR variability and reflect shifts between sympathetic (e.g., decrease in HR variability) or parasympathetic (e.g., increase in HR variability) drive. These measures will be taken during each equine intervention session.
Measured: through study completion, an average of 2 years
Mean Difference in Positive and Negative Affect Scale (PANAS) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
PANAS measures short-term positive and negative emotions. The total PANAS-C score can range from 12 to 60 for the positive affect (PA) scale, with higher values indicating greater PA. Similarly, the score range from 15 to 75 for the negative affect (NA) scale, with higher values indicating greater NA. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the primary outcome at multiple time points: pre-intervention, post-intervention sessions, and post-intervention.
Measured: through study completion, an average of 2 years
Mean Difference in Physical Activity Enjoyment Scale (PACES) for Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
PACES measures enjoyment of activity. The total PACES score can range from 18 to 126, with higher values indicating greater enjoyment. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome after the intervention sessions and post-intervention.
Measured: through study completion, an average of 2 years
Mean Difference in Posttraumatic Stress Disorder Checklist (PCL) for Equine Therapy + TAU cohort compared to the TAU only cohort
PCL measures PTSD symptoms. The total PCL score can range from 17 to 85, with higher values indicating greater PTSD symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Measured: through study completion, an average of 2 years
Mean Difference in Beck Depression Inventory (BDI) for Equine Therapy + TAU cohort compared to the TAU only cohort
BDI measures depressive symptoms. The total BDI score can range from 0 to 63, with higher values indicating greater depressive symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Measured: through study completion, an average of 2 years
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort
Q-LES-Q-SF measures quality of, and satisfaction with, life. The total Q-LES-Q-SF score can range from 14 to 70, with higher values indicating greater satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Measured: through study completion, an average of 2 years
Mean and Standard Deviation of Personal Satisfaction Program Survey for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort
Personal Satisfaction Program Survey measures satisfaction with the program. The total Personal Satisfaction Program Survey score can range from 0 to 210, with higher values indicating greater program satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Measured: through study completion, an average of 2 years
Mean Difference in Toronto Mindfulness Scale (TMS) for Equine Therapy + TAU cohort
TMS measures state mindfulness. The total TMS score can range from 0 to 52, with higher values indicating greater state mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome pre-intervention, post-intervention sessions, post-intervention.
Measured: through study completion, an average of 2 years
Mean Difference in Five Facet Mindfulness Questionnaire (FFMQ) for Horsemanship Skills Training Program.
The total FFMQ score can range from 8 to 40 for each of the facets (observe, describe, act aware, nonjudge, nonreact), with higher values indicating greater levels of mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Mean and Standard Deviation of Demographic information including medical and psychiatric diagnoses
Demographic information as well as medical and psychiatric diagnoses of the participants will be extracted from the electronic medical record. Demographic information includes age, race, ethnicity, and service connection.
Numbers of psychiatric hospitalizations and emergency department visits for 6 months pre- and 6 months post-intervention will be extracted from the electronic medical record.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start19 Dec 2019
- Primary completion19 Dec 2024 (estimated)
- Study completion19 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Utah State University
- Responsible party
- Sponsor
- Investigators
- William R Marchand, MD, Principal investigator, Salt Lake City Veterans' Administration Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832815
- Sponsor's protocol ID
- IRB_00125426
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equine Human Interaction With Veterans
- ClinicalTrials.gov ID
- NCT04832815
- Acronym / sponsor ID
- IRB_00125426
- Conditions
- PTSD
- Keywords
- Equine, PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Collaborators
- Utah State University
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 19 Dec 2024 (estimated)
- Study completion
- 19 Dec 2024 (estimated)
- First posted
- 6 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.
This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Equine Therapy | Experimental | Behavioral: Equine Therapy |
| Treatment as Usual (TAU) | No intervention | – |
| Therapeutic Horsemanship Program | Experimental | Behavioral: Therapeutic Horsemanship Program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently enrolled for services at the VA Salt Lake City Health Care System
- At least one mental health service encounter within the preceding 12 months
- Diagnosed with PTSD by a clinician within the preceding 24 months
- Have a doctor release to participate in equine activities
- Currently enrolled for services at the VA Salt Lake City Health Care System
Key exclusion criteria (5 listed)
- Pregnancy
- Diagnoses of a psychotic spectrum illness and/or cognitive impairment
- Physical disability that would prevent horseback riding
- Weight >= 250 lbs.
- Potentially the severity of and psychological and/or behavioral symptoms will be considered
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 TherapyAim 1: Six session equine interventions. Intervention will be provided one day per week for four weeks. During the first two weeks, each intervention day with consist of two sessions with a lunch break in between. Weeks four and five consist of one trail riding session per intervention day followed by lunch. Each session will be approximately 1.5 hours in length. Sessions 1-4 will occur at the USU Equine Education Center, and session 5-6 will occur on local trails. Optional transportation for participants will be provided from the VA to the intervention site. | Behavioural | Equine Therapy |
| Therapeutic Horsemanship ProgramAim 2: Therapeutic Horsemanship program utilizes the USU Pathways to Horsemanship model and covers levels of equestrian training from basic groundwork to more advanced riding techniques. Training occurs in a three or six-session format with once weekly sessions over three or six weeks. Mindfulness and mindful self-compassion training may be included. | Behavioural | Therapeutic Horsemanship Program |
Primary outcome
Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
Time frame: through study completion, an average of 2 years
AAQII measures psychological flexibility. The total AAQII score can range from 7 to 49, with higher values indicating greater psychological inflexibility. Mixed Effect Modeling will be used for the analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome at multiple time points: pre-intervention, post-intervention for selected or all sessions, and post-intervention.
Heart Rate (HR) Indices
Time frame: through study completion, an average of 2 years
To determine correlations between physiological responses of the rider and horse, the following heart rate (HR) indices will be computed: Mean HR, standard deviation of the beat-to-beat intervals (SDRR) and the root mean square of successive beat-to-beat differences (rMSSD). Both SDRR and rMSSD are measures of HR variability and reflect shifts between sympathetic (e.g., decrease in HR variability) or parasympathetic (e.g., increase in HR variability) drive. These measures will be taken during each equine intervention session.
Mean Difference in Positive and Negative Affect Scale (PANAS) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
Time frame: through study completion, an average of 2 years
PANAS measures short-term positive and negative emotions. The total PANAS-C score can range from 12 to 60 for the positive affect (PA) scale, with higher values indicating greater PA. Similarly, the score range from 15 to 75 for the negative affect (NA) scale, with higher values indicating greater NA. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the primary outcome at multiple time points: pre-intervention, post-intervention sessions, and post-intervention.
Mean Difference in Physical Activity Enjoyment Scale (PACES) for Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
Time frame: through study completion, an average of 2 years
PACES measures enjoyment of activity. The total PACES score can range from 18 to 126, with higher values indicating greater enjoyment. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome after the intervention sessions and post-intervention.
Mean Difference in Posttraumatic Stress Disorder Checklist (PCL) for Equine Therapy + TAU cohort compared to the TAU only cohort
Time frame: through study completion, an average of 2 years
PCL measures PTSD symptoms. The total PCL score can range from 17 to 85, with higher values indicating greater PTSD symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Mean Difference in Beck Depression Inventory (BDI) for Equine Therapy + TAU cohort compared to the TAU only cohort
Time frame: through study completion, an average of 2 years
BDI measures depressive symptoms. The total BDI score can range from 0 to 63, with higher values indicating greater depressive symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort
Time frame: through study completion, an average of 2 years
Q-LES-Q-SF measures quality of, and satisfaction with, life. The total Q-LES-Q-SF score can range from 14 to 70, with higher values indicating greater satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Mean and Standard Deviation of Personal Satisfaction Program Survey for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort
Time frame: through study completion, an average of 2 years
Personal Satisfaction Program Survey measures satisfaction with the program. The total Personal Satisfaction Program Survey score can range from 0 to 210, with higher values indicating greater program satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.
Mean Difference in Toronto Mindfulness Scale (TMS) for Equine Therapy + TAU cohort
Time frame: through study completion, an average of 2 years
TMS measures state mindfulness. The total TMS score can range from 0 to 52, with higher values indicating greater state mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome pre-intervention, post-intervention sessions, post-intervention.
Mean Difference in Five Facet Mindfulness Questionnaire (FFMQ) for Horsemanship Skills Training Program.
Time frame: through study completion, an average of 2 years
The total FFMQ score can range from 8 to 40 for each of the facets (observe, describe, act aware, nonjudge, nonreact), with higher values indicating greater levels of mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention.
1 secondary outcome
Mean and Standard Deviation of Demographic information including medical and psychiatric diagnoses
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
William R Marchand, MD principal investigator
Salt Lake City Veterans' Administration Medical Center
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 Therapy and Therapeutic Horsemanship Program in people with PTSD, run by VA Salt Lake City Health Care System 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
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?
Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program (time frame: through study completion, an average of 2 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.