PostTraumatic Stress DisorderNCT03039361
Equine Assisted Psychotherapy for PTSD
A study testing Equine Assisted Psychotherapy in people with PostTraumatic Stress Disorder, run by University of New Mexico.
Trial summary
The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD symptoms in veterans with PTSD as compared with existing care. The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms following participation in a 6-week Equine Assisted Psychotherapy… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PostTraumatic Stress Disorder
- What is being tested?
- Equine Assisted Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will include war veterans with post-traumatic stress disorder, who have a PCL-M symptom score of ≥ 29 with an age between 18 and 75.
Who cannot join
- Adults unable to consent, individuals aged < 18 years, individuals receiving antipsychotic medication, individuals receiving glucocorticoid therapy, and/or pregnant women.
About this study
The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD symptoms in veterans with PTSD as compared with existing care.
The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms following participation in a 6-week Equine Assisted Psychotherapy program.
Read the detailed description
This study will employ a randomized, parallel group design with delayed intervention in the control group. Eligible participants will be randomly assigned using a random number generator. The PTSD Checklist (PCL) - Military (measuring PTSD symptoms) will be administered to each participant at week 0 and week 6. Permissions have been obtained for the use of the survey.
Surveys will be identified by randomized number only, to maintain confidentiality. Participants will be assigned a unique identifier. A list of participant's initials and their random assigned numbers will be kept in a locked secure file by the investigator. In this way the participants confidentially will be protected.
The participants assigned to the intervention group will complete the Equine Assisted Psychotherapy (EAP) program that will be performed at an Equine Assisted Growth and Learning Association (EAGALA) certified facility. The participants will be going through a 6 week program. The researcher will not be conducting the therapy. An EAGALA certified and licensed Occupational Therapist will be running the therapy as well as a professional Horse Handler for safety. In the event that a participant is in need of additional therapy as a result of this research, a psychotherapist will be on call. Participation will not include riding the horses. "The basis of the EAGALA Model is a belief that all clients have the best solutions for themselves when given the opportunity to discover them. Rather than instructing or directing solutions, [the instructor] allow [their] clients to experiment, problem-solve, take risks, employ creativity, and find their own solutions that work best for them. No horseback riding is involved. Instead, effective and deliberate techniques are utilized where the horses are metaphors in specific ground-based experiences." (http://www.eagala.org/Information/What_Is_EAGALA_Model) All horse based activities involve inherent risk. The facility and the horses that the participants will be using are used daily for Hippotherapy involving disabled individuals. All safety procedures and precautions outlined by the EAGALA certifications and the therapy facility will be strictly maintained. The participants may decline to do any of the therapy activities and or survey questions at any time. If the certified therapist senses a problem, they will stop the therapy and consult with a psychotherapist.
The participants assigned to the control group will have no intervention related to the research but may continue any preexisting therapy. They will be asked to not initiate any new therapy programs. The participants will be however given the option of delayed EAP after the completion of the 6 week program.
- Conditions
- PostTraumatic Stress Disorder
- Being tested
- Equine Assisted Psychotherapy
- 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 PsychotherapyBehavioural
Also called Equine Assisted Therapy
Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Equine Assisted Psychotherapy | Experimental | 6 week Equine Assisted Psychotherapy program Receives: Behavioral: Equine Assisted Psychotherapy |
| Control | No intervention | Standard of Care, Existing PTSD therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 17-item PCL-Military (PTSD Symptoms)
A validated and widely used survey instrument to assess PTSD symptoms for the purposes of diagnosis, clinical assessment, and scientific inquiry. Scores range from 17 to 85 in severity, with anything over 29 as having PTSD.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startJan 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostTraumatic Stress DisorderStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark R Burge, MD, Principal investigator, UNM Clinical Translational Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039361
- Sponsor's protocol ID
- 13-547
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will be provided in Lobo vault after finalization of the study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equine Assisted Psychotherapy for PTSD
- ClinicalTrials.gov ID
- NCT03039361
- Acronym / sponsor ID
- 13-547
- Conditions
- PostTraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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 purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD symptoms in veterans with PTSD as compared with existing care.
The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms following participation in a 6-week Equine Assisted Psychotherapy program.
Detailed description
This study will employ a randomized, parallel group design with delayed intervention in the control group. Eligible participants will be randomly assigned using a random number generator. The PTSD Checklist (PCL) - Military (measuring PTSD symptoms) will be administered to each participant at week 0 and week 6. Permissions have been obtained for the use of the survey.
Surveys will be identified by randomized number only, to maintain confidentiality. Participants will be assigned a unique identifier. A list of participant's initials and their random assigned numbers will be kept in a locked secure file by the investigator. In this way the participants confidentially will be protected.
The participants assigned to the intervention group will complete the Equine Assisted Psychotherapy (EAP) program that will be performed at an Equine Assisted Growth and Learning Association (EAGALA) certified facility. The participants will be going through a 6 week program. The researcher will not be conducting the therapy. An EAGALA certified and licensed Occupational Therapist will be running the therapy as well as a professional Horse Handler for safety. In the event that a participant is in need of additional therapy as a result of this research, a psychotherapist will be on call. Participation will not include riding the horses. "The basis of the EAGALA Model is a belief that all clients have the best solutions for themselves when given the opportunity to discover them. Rather than instructing or directing solutions, [the instructor] allow [their] clients to experiment, problem-solve, take risks, employ creativity, and find their own solutions that work best for them. No horseback riding is involved. Instead, effective and deliberate techniques are utilized where the horses are metaphors in specific ground-based experiences." (http://www.eagala.org/Information/What_Is_EAGALA_Model) All horse based activities involve inherent risk. The facility and the horses that the participants will be using are used daily for Hippotherapy involving disabled individuals. All safety procedures and precautions outlined by the EAGALA certifications and the therapy facility will be strictly maintained. The participants may decline to do any of the therapy activities and or survey questions at any time. If the certified therapist senses a problem, they will stop the therapy and consult with a psychotherapist.
The participants assigned to the control group will have no intervention related to the research but may continue any preexisting therapy. They will be asked to not initiate any new therapy programs. The participants will be however given the option of delayed EAP after the completion of the 6 week program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equine Assisted Psychotherapy | Experimental | Behavioral: Equine Assisted Psychotherapy6 week Equine Assisted Psychotherapy program |
| Control | No intervention | –Standard of Care, Existing PTSD therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will include war veterans with post-traumatic stress disorder, who have a PCL-M symptom score of ≥ 29 with an age between 18 and 75.
Key exclusion criteria (1 listed)
- Adults unable to consent, individuals aged < 18 years, individuals receiving antipsychotic medication, individuals receiving glucocorticoid therapy, and/or pregnant women.
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 PsychotherapyAlso: Equine Assisted TherapyTherapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy. | Behavioural | Equine Assisted Psychotherapy |
Primary outcome
Change in 17-item PCL-Military (PTSD Symptoms)
Time frame: Baseline and 6 weeks
A validated and widely used survey instrument to assess PTSD symptoms for the purposes of diagnosis, clinical assessment, and scientific inquiry. Scores range from 17 to 85 in severity, with anything over 29 as having PTSD.
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 7 Mar 2018.
- Individual participant dataSharing planned: No. Individual participant data will be provided in Lobo vault after finalization of the study.
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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.
Mark R Burge, MD principal investigator
UNM Clinical Translational Science Center
Questions about this trial
What is this clinical trial studying?
A study testing Equine Assisted Psychotherapy in people with PostTraumatic Stress Disorder, run by University of New Mexico.
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 1 inclusion and 1 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 in 17-item PCL-Military (PTSD Symptoms) (time frame: Baseline and 6 weeks). 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 7 Mar 2018.