Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: Research Foundation for Mental Hygiene, Inc.

Cover Page for ClinicalTrials.gov 
Official Title of the Study: 
 
Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD 
NCT Number:  
 
NCT03068325 
Principal Investigator: 
Yuval Neria, PhD  
Yuval.Neria@nyspi.columbia.edu  
646-774-8041 
Date of Document: 
 
February 9, 2022 
 
 

Statistical Analysis Plan 
 
The Little MCAR (missing completely at random) test on total scores for the CAPS-5, 
PCL-5, HDRS, and BDI-II from each time point following the baseline assessment (i.e., 
midpoint, posttreatment, and follow-up analysis) will be used to test whether data is missing at 
random.  
In line with previous open-trial studies exploring novel psychotherapies for different 
psychopathologies, we will use an intent-to-treat analysis, thereby enabling data analysis for all 
63 patients. Provided that missing data is minimal and missing at random, we will conduct the 
intent-to-treat analysis with full information maximum likelihood (FIML), a gold standard 
approach to handling missing data. In addition, we will repeat analyses for patients who 
complete assessments at all four time points. Treatment effects will be explored using a repeated-
measures analysis of variance (ANOVA) with time (pretreatment, midpoint, posttreatment, and 
follow-up) as a within-subjects factor. Post hoc tests using the Bonferroni correction will be used 
to compare the different time points. All statistical tests will be 2-sided, using α < .05. Effect 
sizes will be reported using η2p and Cohen d when appropriate. 

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Protocol Title:
Trauma-Focused Equine-Assisted 
Treatment (TF-EAT) for Veterans with 
PTSD
Protocol Number:
7232
First Approval:
03/11/2016
Expiration Date:
02/21/2023
Version Date:
02/09/2022
Contact Principal Investigator:
Yuval Neria, PHD
Email: ny126@columbia.edu
Telephone: 646-774-8092
Co-Investigator(s):
John Markowitz, MD
Prudence Fisher, PHD
Research Chief:
Helen Simpson, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications 
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
Clinical Therapeutics
Within the department, what Center or group are you affiliated with, if any? 
Anxiety Disorders Clinic
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 

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State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
Allan Hamilton, MD
Jane Hamilton, PhD
Anna Gassib 
Application for Continuation of Research
Status
Current Status of Study: 
All research interventions were completed. Only data analysis is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
71 patients with Posttraumatic Stress Disorder (25 females, 46 males) were enrolled. Of the
enrolled patients, 8 were enrolled as part of the pilot phase, and 63 were enrolled as part of the trial, which 
has since concluded active enrollment. No serious adverse events occurred. One paper has been published 
since last year (Fisher, P. W., Lazarov, A., Lowell, A., Arnon, S., Turner, J. B., Bergman, M., Ryba, M., 
Such, S., Marohasy, C., Zhu, X., Suarez-Jimenez, B., Markowitz, J.C., & Neria, Y. (2021). Equine-Assisted 
Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. The Journal of 
Clinical Psychiatry, 82(5), 36449.). Analysis of the data is ongoing.
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No

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Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 
No
Overall Progress
Approved sample size
73
Total number of participants enrolled to date
71
Number of participants who have completed the study to date 
64
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Sample Demographics
Specify population
Veterans
Total number of participants enrolled from this population to date 
71
Gender, Racial and Ethnic Breakdown 
Gender:
Male: 36 (65%)
Female: 25 (35%)
Race:
Black/African American: 34 (48%)
White: 22 (31%)
Asian: 23 (32%)
American Indian/Alaskan: 2 (3%)
Mixed: 2 (3%)
Other: 5 (7%)
Unknown: 3 (4%)
Ethnicity:
Hispanic: 20 (28%)
Non-Hispanic: 51 (72%)

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Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
0
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
Collection of Biological Specimens
MRI
Audio or Videotaping
Population
Indicate which of the following populations will be included in this research
Adults
Adults over 50
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
No
Who is the PI of the grant/contract?
Fisher, Prudence, PHD
Select one of the following
The grant/contract is currently funded
Source of Funding

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Foundation
Sponsor
Mack Foundation
Select one of the following
Single Site
Business Office
RFMH
Does the grant/contract involve a subcontract? 
No
Study Location
Indicate if the research is/will be conducted at any of the following
NYSPI
This protocol describes research conducted by the PI at other facilities/locations
Yes
Other Facilities
Other Facilities
Type in location(s)
Bergen Equestrian Center
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
This pilot study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of trauma-
focused Equine-Assisted Therapy (EAT) for veterans and military servicemembers with posttraumatic stress 
disorder (PTSD). While several well-studied, validated treatments for PTSD exist, some individuals find 
these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy widely used by 
organizations, such as PATH International Equine Services, that endorse its effectiveness for treating a 
variety of mental health issues. These claims have drawn criticism because the published research contains 
glaring methodological flaws, making it difficult to assess how effective these therapies actually are 
(Anestis et al., 2014). Equine-assisted therapies present a unique treatment modality that might effectively 
treat PTSD, particularly for individuals who have difficulty with other treatment modalities. In EAT, a 
psychotherapist and equine specialist work together to help the patients negotiate interactions with a horse 
using structured interventions or activities. EAT has only recently begun to be studied in populations with 
PTSD, but shows promise. In a six week open, non-manualized trial for 16 civilians with PTSD, Earles et al. 
(2015) examined a structured EAT approach called Equine Partnering Naturally© for treating PTSD, 
finding a significant reduction in PTSD symptoms post treatment. The authors propose that EAT may be an 
effective technique for treating PTSD symptoms. Other limitations aside, this study does not address a 

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significant proportion of the potential treatment population for treatment of PTSD with EAT, namely 
military veterans and servicemembers.
This pilot study aims: (1) to create and test a trauma-focused EAT manual; (2) to examine feasibility of 
EAT for military veterans with PTSD; (3) to examine the acceptability of and satisfaction with EAT for 
both patients and treatment providers; and (4) to examine both the physical safety (risk of injury from 
equine interactions) and psychological safety (potential adverse response) of a group equine-related 
treatment, 5) to explore the possibility of neural changes among treated patients by collecting pilot 
multimodal (structural, functional) magnetic resonance imaging (MRI) data before and after treatment.
The sample will consist of veterans and servicemembers with PTSD (n=48) who have been assessed 
through the Columbia Veterans Research Center (IRB #7218), or preferred to be screened directly as a 
response to advertisement. In Phase 1, aiming to finalize the EAT manual, 8 veterans and servicemembers 
will be treated in 2 groups of 4 veterans each. Participants will be evaluated at baseline, at treatment mid-
point (week 4), and at the end of treatment.
In Phase 2, where the EAT manual will continue to be evaluated, the remainder of the sample (n=40) will be 
treated in 6-8 groups (4-6 veterans each). Participants will be evaluated at baseline, at treatment mid-point 
(week 4), at end of treatment (week 8), and at three-month follow-up by independent 
evaluators. Additionally, patients will be scanned at baseline and end of treatment. Structural MRI scans 
will be performed to quantify regional brain volumes and cortical thickness, and resting state fMRI will 
measure functional connectivity within hippocampal networks.
Background, Significance and Rationale
Background, Significance and Rationale
Posttraumatic stress disorder (PTSD) is a debilitating disorder highly prevalent among military veterans and 
servicemembers. It is defined by a fearful response to traumatic events, and involves re-experiencing, 
hyperarousal, and avoidance of reminders of the traumatic events. While some widely practiced therapies 
have demonstrated efficacy for treating PTSD, for instance Prolonged Exposure therapy (PE), alternative 
treatment modalities offer opportunities for individuals who either do not wish to try or do not benefit from 
empirically validated therapies. However, alternative treatments often lack rigorous empirical justification 
of their treatment efficacy. 
Equine-Assisted Therapy (EAT) is an alternative treatment practiced across the United States. EAT uses the 
horse as a therapeutic tool in an experientially-oriented therapy. Horses are thought to somewhat resemble 
humans in their behavior, particularly in social contexts (Schultz et al., 2007). In EAT, a psychotherapist 
and equine specialist work together to help the patient negotiate interactions with a horse using structured 
interventions or activities. Selby and Smith-Osborne (2013) note that horses bring specific attributes to the 
therapeutic environment including patience, receptiveness, and cooperation. A horse is a prey animal that is 
naturally skittish. Precisely because of their difference in size and strength, but similarity in sensitivity and 
reactivity to others, working with horses represents a holistic experience for patients who are themselves 
anxious. 
EAT may offer some veterans and servicemembers with PTSD an opportunity to receive treatment in a less 

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traditional format, possibly decreasing treatment attrition relative to prevalent exposure-based treatments, 
while maintaining a treatment structure similar to established therapies (e.g., a regular schedule). While 
more traditional psychotherapies have demonstrated efficacy in treating PTSD, not all individuals respond 
well to these treatments. Although a small body of literature describes equine-related treatment (ERT), a 
recent review by Anestis et al. (2014) identified numerous critical methodological problems and conflicts of 
interest in prior ERT research. The current study hopes to address some of these limitations. No developed 
treatment manuals exist. Studies have not necessarily distinguished between EAT and therapeutic horse 
riding (THR). Treatment fidelity has been absent: there are no references to supervision, and there has been 
no clear manualization of the treatment being used. Further, most studies to date have used as outcome 
measures quality of life indices (sometimes only self-reported) rather than clinical measures such as the 
Clinician-Administered PTSD Scale (CAPS; Blake et al., 1995). Thus despite claims of ERT effectiveness 
for PTSD, and some studies that have included individuals with PTSD, the extant research suffers from 
methodological flaws that confound interpretation of the data. Only very recently has any published 
research addressed EAT and PTSD, with the researchers claiming its “efficacy” based on a small open trial 
(Earles, Vernon, & Yetz, 2015). The current study will focus specifically on military veterans and 
servicemembers with PTSD, a group never studied in the context of ERT at all. The study aims to develop a 
trauma-specific, manualized treatment for EAT.
Specific Aims and Hypotheses
Specific Aims and Hypotheses
In this pilot study we will further develop the TF-EAT intervention and determine whether research 
methods (evaluation interviews, assessment measures, videotaping procedures etc.) are acceptable to 
participants. An open trial of this intervention and the draft manual will be finalized in Phase 1 and 
evaluated in Phase 2. Specifically, we will focus on issues such as session length, appropriateness of the 
“content” for treatment of PTSD, ordering of session content, adherence to the intention of the manual of 
the equine therapeutic team (based on observations made during supervision and feedback from the 
consultants), and will detail logistics of data collection and how best to record the sessions (camera angles, 
etc.). We will conduct 2 groups of 4-6 participants for Phase 1 and 6 groups of 4-6 participants for Phase 2.  
Description of Subject Population
Sample #1
Specify subject population
Veterans
Number of completers required to accomplish study aims
60
Projected number of subjects who will be enrolled to obtain required number of completers

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70
Age range of subject population
18-75
Gender, Racial and Ethnic Breakdown
Gender:
10% female
90% male
Ethnicity:
15% Hispanic
60% White
15% African-American
10% Other. 
Description of subject population
All patients will have DSM-5 diagnosis of PTSD. The expected sex and ethnicity distributions are based on 
population data drawn from the VA. 
Recruitment Procedures
Describe settings where recruitment will occur
Anxiety Disorders Clinic
How and by whom will subjects be approached and/or recruited? 
Patients will respond to an advertisement (see below" study advertised/ publicized"). Patient will call the 
clinic and after verbal is obtained consent the research assistant (RA) will conduct a preliminary phone 
screen that is part of a preexisting screening protocol (IRB # 7094R). If the patient will be eligible for the 
study the RA will invite him for further screening at the clinic. Current or prospective patients of the 
Columbia Veterans Research Center (IRB #7218) may also be referred for this treatment study as 
appropriate.
How will the study be advertised/publicized? 
Potential subjects will be informed of the study through: (a) referrals from the Department of Veteran 
Affairs, (b) word-of-mouth referrals from former subjects, (c) referrals from area medical and mental health 
professionals, (d) publicity about the study, including articles in local newspapers and magazines, our IRB-
approved website (http://columbiapsychiatry.org/ptsd), IRB approved flyers, appearances on local radio and 
television shows, etc., leading to self-referral of prospective subjects, (e) advertisements placed in local 
media and on the Internet. (f) Attendance by study personnel at local veterans’ events.
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
No

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Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes
Describe concurrent research involvement
Participants may be recruited from the Columbia Veterans Research Center (IRB #7218), as well as other 
studies concerning PTSD conducted through our department as appropriate, such as Neural Signature of 
Trauma (IRB #7136).
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Veterans
Create or insert table to describe the inclusion criteria and methods to ascertain them
Inclusion criteria:
Method of Ascertainment:
1. Between ages of 18 and 75
History
2. Current DSM-5 diagnosis of PTSD as 
determined by a) full criteria met on 
CAPS-4, and b) clinical assessment
SCID, CAPS-4, Clinical 
Assessment
3. CAPS-4 score equal to or greater than 
50 
CAPS-4 administration
 4. Able to give consent, fluent in English. Clinical assessment, Clinical 
judgment
 5. Prior military experience 
History, Columbia Veterans 
Research Center Background 
Information Questionnaire
 6. MMSE score equal to or greater than 24
(for participants over 60 years of age)
MMSE administration
Create or insert table to describe the exclusion criteria and methods to ascertain them
 Exclusion criteria: 
Method of Ascertainment:
1. History of psychiatric diagnosis 
of psychotic disorder, unstable 
bipolar disorder.
 SCID (including personality disorder 
modules) and clinical evaluation
2. Elevated depression of clinical 
concern and/or score of >25 on the 
Hamilton Rating Scale for 
Depression (HAM-D-17-item). 
Clinical assessment, HAM-D 17 and 
BDI-II. All cases of PTSD and 
comorbid depression will be reviewed 
by PI and clinician for exclusion 

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determination.
3. At elevated risk for suicide based 
on history and current mental state. 
Psychiatric history; clinical 
assessment, Columbia Veterans Center
Suicide Risk Assessment and 
Screener; score >2 on item 3 of 
Hamilton Depression Scale, and/or 
suicide item endorsed on BDI-II. 
 4. History of substance/alcohol use 
disorder at severe level within the 
past six months, and current 
diagnosis of substance/alcohol use 
disorder at a moderate level within 
past two months 
 History, SCID
5. Fear of horses or other large 
animals
Phone screen, clinical assessment
6. Orthopedic or other physical 
conditions and/or limitations that 
prevent people from walking 
unassisted and/or walking freely in 
the ring
Phone screen, clinical assessment
7. Having contraindication to 
magnetic resonance imaging (MRI) 
scanning (such as metal in body) or 
unable to tolerate the scanning 
procedures. (MRI only)
Phone screen, clinical assessment, 
MRI screening questionnaire
 8. Acute, unstable, or severe 
medical disorder. (MRI only)
 Phone screen, clinical assessment
 9. Pregnancy, or plans to become 
pregnant during the period of the 
study. (MRI only)
Clinical assessment, Urine 
 HCG for
women of childbearing potential on 
each day of fMRI
10. Significant claustrophobia that 
would preclude ability to remain 
calm within the MRI scanner
 Phone screen, history
 11. Cardiovascular disease (e.g. 
congestive heart failure, heart 
arrhythmias, sinus bradycardia, and 
greater than a first degree block; for 
participants over 60 years of age)
 EKG
Waiver of Consent/Authorization

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Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
No
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
Yes
Indicate NYSPI IRB # 
7094R, 7218
Describe Study Consent Procedures
Patient will meet face to face with a person that is authorized to discuss and document consent (see “person 
designed to discuss and document consent”). After patient reads the consent the clinician will go over the 
consent with the patient and answer all the patient’s questions. After answering all the patient’s questions by 
the clinician patient will sign the study consent. Throughout this process, the patient will be told that they 
are free to refuse to participate in the research and that participation or non-participation in research has no 
effect on their ability to continue to receive clinical care or services. Patients who chose not to participate in 
this study are still eligible for treatment in the Columbia Veterans Research Center (IRB #7218). Patients 
will also be asked to sign a standard liability waiver provided by the Bergen Equestrian Center (Attached).
Indicate which of the following are employed as a part of screening or main study consent procedures
Consent Form
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Fisher, Prudence, PHD
Markowitz, John, MD
Neria, Yuval, PHD
Type in the name(s) not found in the above list
Maja Bergman, MA
Study Procedures

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Describe the procedures required for this study
As shown in the study overview flow chart below, the study comprises the following procedures: 1) 
eligibility assessment; 2) assessment visit; 3) treatment (during which there will a separate (additional) 
meeting with an IE at baseline and week 4); 4) end of treatment assessment; 5) follow up assessment (3 
months after treatment end). As follows: 
Flow Chart of Study Procedures
Visit 0: 
Eligibility 
Assessment 
Visit 0.5: 
Assessment 
(and first 
MRI scan 
for eligible 
subjects)
Weeks 1-8: 
Once weekly 
Trauma-
modified 
Equine-
assisted 
therapy.  
These visits 
will last 90 
minutes and 
take place at 
the equine 
facility. 
Visit 8:
End of 
treatment 
arm (and 
second MRI 
scan for 
eligible 
subjects)
 Visit 10: 3 
month 
follow up 
assessment 
Clinical 
assessment, 
Informed Consent, 
SCID & CAPS 4 
and CAPS-5, 
Patient Treatment 
Log MMSE for 
participants over 60
years of age, TBI 
ID for MRI 
subjects, EKG for 
MRI subjects over 
60 years of 
age, Interview, self-
report measures.
Informed 
consent, 
self-report 
measures. F
or MRI 
subjects:1.25
hr scan
Between 
treatment 
visits 4 and 5 
participants 
will complete 
self-ratings 
and  IE will 
administer 
clinical ratings
at NYSPI 
(CAPS-4 and 
CAPS-5,  
HAM-D 17, 
CGI, Patient 
Treatment 
Log)
 Independent
evaluator 
and self-
ratings (1.5 
hrs.) For 
MRI 
subjects:1.25
hr scan
Independen
t evaluator 
and self-
ratings (1.5 
hrs.)
Table 1. Flow Chart of Assessments for Study Participants 
Wk
0
Wk
.5
Wk
1
Wk
2 
 W
k 3
Wk
4 
Wk
4.5
Wk
5
Wk
6 
Wk
7 
Wk
8 
Wk
8.5
Wk
20 
Clinical Assessment
x
 
 
 
 
 
 
 
 
 
 
SCID 
x
 
 
 
 
 
 
 
 
 
 

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 HAM-D 17
x
 
 
 
 
 
 x
 
 
 
 
 x
 x
LEC-5
x
 
 
 
 
 
 
 
 
 
 
 
 
CAPS-4
x
 
 
 
 
 
 x
 
 
 
 
 x
 x
 MMSE
x
 
 
 
 
 
 
 
 
 
 
 
 
 TBI ID
x
 
 
 
 
 
 
 
 
 
 
 
 
 Informed Consent
 x
 
 
 
 
 
 
 
 
 
 
 
 CAPS-5
x
 
 
 
 
 
 x
 
 
 
 
 x
 x
 Patient Treatment Log x
 
 
 
 
 
 x
 
 
 
 
 x
x 
ADC Demographics
x
 
 
 
 
 
 
 
 
 
 
 
 
 CVC Background 
Information 
Questionnaire
x
 
 
 
 
 
 
 
 
 
 
 
 
 CGI-severity
x
 x
 x
 x
 x
 x
 x
 x
 x
 x
 x
 x
x 
 CGI-change
x
 x
 x
 x
 x
 x
 x
 x
 x
 x
 x
 x
x 
 PCL-5
x
 
 
 
 
 
 x
 
 
 
 
 x
 x
 BDI
x
 x
 
 
 
 
 x
 
 
 
 
 x
 x
 SAS
 x
 
 
 
 
 x
 
 
 
 
 x
 x
 Q-LES-SF
 x
 
 
 
 
 x
 
 
 
 
 x
 x
 SF-12
 x
 
 
 
 
 x
 
 
 
 
 x
 x
 FAD
 x
 
 
 
 
 
 
 
 
 
 
 
 M2C-Q
 x
 
 
 
 
 
 
 
 
 
 
 
 CSQ-8
 
 x
 
 
 x
 
 
 
 
 x
 
 
 Credibility/Expectanc
y Q
 
 x
 
 
 x
 
 
 
 
 x
 
 
 POMS
 
 x
x 
 x
 x
 
 x
 x
x 
 x
 
 x
CTQ
x
   
GAD-7
x
x
x
x
CVC Suicide Risk 
Assessment and 
Screener
x
x
x
DRII-2
x
VATBIST
x
CAGE-AID
x
4.A1. Preliminary Screening: Potential subjects will be screened by telephone by a research assistant after 
obtaining oral consent. 
Eligibility Assessment: Potential participants deemed as likely study eligible following preliminary 
screening will sign the Anxiety Disorders Clinic informed written consent for the initial evaluation (IRB # 
7049R) and undergo assessment as per the Columbia Veterans Research Center protocol (IRB#7218). As 

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part of this protocol,  an experienced clinician will evaluate presenting symptoms, psychiatric history, 
treatment history, medical history, military history, trauma history, social and family history, and current 
medical status. Participants will also complete a battery of self-report measures, including measures utilized 
by the Columbia Veterans Research Center as part of diagnostic and history assessment (30 minutes). In 
addition, a trained research team member will administer the Clinician-Administered PTSD scale (CAPS-4 
and 5), structured clinical interview for DSM-5 (SCID), HAM-D 17, Patient Treatment Log, the TBI ID for 
subjects considering MRI participation, and the Mini Mental State Exam for participants over 60 years of 
age. An EKG will be administered to participants over the age of 60 who are considering MRI participation. 
These interviews will determine whether individuals meet inclusion criteria have been met. Finally, a urine 
sample will be collected from female subjects who appear to be eligible to participate in the MRI scans to 
test for pregnancy. 
4.A2. MRI Scanning: For the MRI procedures, the subject will be instructed to lie as still as possible within 
the magnet for approximately 45 minutes. When we position a subject in the scanner, head movement will 
be minimized through: (a) instructions to the participant; and (b) packing the head inside the head coil with 
a system of foam padding and pillows that we have found is well-tolerated by the participants, yet limits 
movement. All precautions and protections will be given to the participant to ensure that they are as safe and 
comfortable as possible. For the participant’s comfort within the scanner, they will lie on a padded table 
with a pillow to rest their heads on. A blanket will also be provided to keep subjects warm during the 
procedure.
fMRI Scan
For all subjects eligible to undergo fMRI scanning, there will be two fMRI sessions. MRI scans will be 
performed in the NYSPI 3.0T GE scanner. The scanning session will last approximately 45 minutes, with an 
additional 30 minutes total for set-up . subjects will have a urine pregnancy test on the day of the MRI scan, 
before being scanned. Thus, the fMRI session lasts about 1 hr and 15 minutes .
MRI Results
If the neuroimaging studies reveal significant deficit or an emergent and previously undiagnosed medical 
condition, this information will be discussed with the participants and transmitted to their physician.
The same procedure will be used for Phase 1 (finalizing manual) and Phase 2 (evaluating manual). 
4.A.3. Treatment: 
Group treatment sessions will be carried out at the Bergen Equestrian Center, NJ (EAT). The research team 
will provide transportation to the equestrian center, although some participants may choose to provide their 
own transportation to the sites. Participants who choose to have the research team provide transportation 
will be driven to and from the site in an NYSPI van driven by one of the researchers involved in the 
protocol. Treatment sessions will be videotaped to ensure integrity to the treatment manual under 
development.
4.A.3.1 Trauma-focused equine-assisted therapy (TF-EAT)
Elements of the treatment include psychoeducation about PTSD and a variety of activities with the horses 

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such as Exposure & Disclosure, Support & Education, Stress inoculation, Cognitive processing & 
restructuring, Countering avoidance & distortions. Participants in the therapy DO NOT RIDE the horses; all 
work with the horse is done from the ground. In each session the group meets to discuss thoughts about the 
previous week, new issues, and issues to be worked on. Subjects then undertake a series of interactions with 
a horse as well as checking in with the therapist between activities. These activities include grooming the 
horse and moving the horse without forcing it to move. Each week the activities become more elaborate, 
terminating with the subject completing a series of maneuvers with the horse.
A manual is being drafted to provide clear structure for the course of treatment (this manual is under 
development with consultations from Allan Hamilton, MD and Jane Hamilton, PhD). The Drs. Hamilton 
direct the Rancho Bosque Equine Center, where they administer EAT among other therapy groups.
The first two groups to complete the treatment will be used to further specify the treatment protocol. The 
manual will be modified based on feedback received from patients and therapists regarding how well the 
manual captures the intended treatment. This will be a group treatment delivered by one licensed mental 
health therapist, one EAGALA*-certified “equine” trained person, and two (or three) horses that have been 
used for equine therapy. There will be one horse per two participants. For each horse, we will have one (or 
more) team members, experienced with horses. Thus, for a group of six participants, we will have an extra 
“horse” person (“wrangler") in the ring/pen to ensure safety. (We will forward a copy of the manual to the 
IRB when a more complete draft has been prepared). All sessions will be videotaped.
*EAGALA (Equine Assisted Growth and Learning Association) (www.EAGALA.org) is the leading 
international nonprofit association for professionals incorporating horses to address mental health and 
personal development needs. The organization provides guidelines, training and certification for equine 
therapists in the “EAGALA Model” which has four tenets: 1. Team approach (Licensed therapist and equine 
therapist and horse), 2. Focus on ground (NO RIDING), 3. Solution Oriented (problem solving): 4. Code of 
Ethics.
4.A.4. Feedback Protocol
Feedback will be gathered from participants through two methods. First, two self-report questionnaires, the 
Client Satisfaction Questionnaire (CSQ-8) and the Credibility/ Expectancy Questionnaire, will be 
administered during treatment sessions 1, 4, and 8 to ascertain whether participants feel the treatment meets 
their needs and if they believe it is helping to alleviate their symptoms. Second, upon completing the 
treatment, a researcher will interview participants to gather feedback on their overall experience in the 
treatment. These interviews will be audiotaped and used in combination with the CSQ-8 and 
Credibility/Expectancy Questionnaire to inform modifications to the treatment. Staff members will also 
interview therapists post treatment to gather feedback on their perceived efficacy of the intervention. These 
interviews will also be audiotaped and used to inform decisions on modifying the intervention. 
4.A.5. Therapists and adherence to protocol: 
For equine therapy, Therapists (MD or PhD level, or Masters level for social workers) will be trained and 
supervised weekly, by Drs.Prudence Fisher, Ari Lowell, and Jane Hamilton (consultant). Horse handlers 
will be trained and supervised by Dr. Allan Hamilton. Dr. Hamilton is an equine expert with significant 
experience in developing EAT exercises and training horses for use in EAT. Drs. Jane and Allan Hamilton 
will view videotapes of sessions and midway through the project make a quarterly farm visit in person to 
ensure adherence.
4.A.6. Termination Procedures

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Drs Neria, Fisher and Markowitz, in consultation with treating clinicians, will review all currently enrolled 
patients in treatment in a weekly meeting. Patients may be removed from the study upon:
1. Requests to withdraw from the study.
2. Elevated level of distress, for PTSD patients demonstrated by a score of 6 or higher on the weekly CGI 
for two consecutive weeks, unless the distress is due to an acute transient event (to be evaluated by treating 
clinician, and the PI). The CGI will be administered to consider both PTSD and Depression 
symptomatology.
3. Non-improvement in PTSD at week 4, as measured by the CGI-I at the level of 4 (no improvement) or 
higher. 
4. Significant suicidal ideation, as assessed by the clinician and/or by the HAM-D-Item 3 and/or the BDI 
suicide item and/or the CVC Suicide Risk Assessment and Screener.
5. Clear-cut deterioration in social or occupational functioning as assessed by the clinician. 
6. Non-compliance with protocol requirements. 
7. New or inter-current illness that prevents the patient from complying with the protocol. 
Upon termination from this study, patients may be offered alternative treatment within the Columbia 
Veterans Research Center (IRB #7218). Patients removed from treatment due to elevated suicide risk will be 
assessed by Columbia Veterans Research Center MD/PhD clinicians and provided with immediate 
assistance as appropriate.
You can upload charts or diagrams if any
Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
All labs will be collected under the screening protocol (IRB #7094R). A urine sample will be collected for 
pregnancy tests at the initial evaluation and prior to the MRI scans for female participants.
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
SCID (90 minutes at screening)
Beck Depression Inventory (10 minutes)
Clinical Global Impression – Severity Scale (CGI-S) (5 minutes)
Clinical Global Impression – Change Scale (CGI-S) (5 minutes) 
Clinician Administered PTSD Scale (CAPS-4) (30 Minutes) 
Clinician Administered PTSD Scale (CAPS-5) (30 Minutes) 
PTSD Checklist (PCL-5) 
Hamilton Rating Scale for Depression (Ham-D 17) (10 minutes)
Mini Mental State Exam (MMSE) 
Quality of Life (SF-12) (10 minutes) 
Family Assessment Device (FAD) (15 minutes)
Client Satisfaction Questionnaire (CSQ-18/CSQ-8)
Credibility/Expectancy Questionnaire

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M2C-Q
Life Events Checklist (LEC-5)
POMS
Q-LES-Q-SF
SAS
Childhood Trauma Questionnaire (CTQ) (5 minutes)
CAGE-AID Questionnaire (CAGE-AID) (5 minutes)
Columbia Veterans Center Background Information Questionnaire (5 minutes)
Columbia Veterans Center Suicide Risk Assessment and Screener (10 minutes)
Deployment Risk and Resilience Inventory (DRRI-2) (20 minutes)
Generalized Anxiety Disorder 7-Item (GAD-7) (5 minutes)
VA Traumatic Brain Injury Screening Tool (VATBIST) (5 minutes)
Anxiety Disorders Clinic Demographic and Clinical Information (5 minutes)
Traumatic Brain Injury Identification Method (TBI ID) 5 minutes 
Clinician Administered Patient Treatment Log (5 minutes) 
Please attach copies, unless standard instruments are used
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment 
We are not excluding veterans who are currently in treatment, so for these there will be no delay in 
treatment. For veterans who are not in treatment, the maximum delay to treatment provided in the study is 6 
weeks. This allows time to recruit enough participants to create groups. All patients will have access to 
treating clinicians through the Columbia Veterans Research Center (IRB #7218) for any emergent clinical 
issue. If a delay in treatment extends to four weeks we will offer alternative treatment within the Columbia 
Veterans Research Center (IRB #7218).
Maximum duration of delay to standard care or treatment of known efficacy
The maximum delay before active treatment of known efficacy is offered will be 10 weeks: two weeks for 
assessments and eight weeks for treatment visits.
Treatment to be provided at the end of the study
Treatment will be provided through the Columbia Veterans Research Center (IRB #7218). Participants will 
be referred for further treatment as needed.
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
Interviews/assessments: Some subjects may find the interviews and assessment anxiety provoking or 
upsetting.

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Trauma-Focused Equine-Assisted Therapy: (1) Patients may become distressed by the discussion of 
sensitive or painful material or by the experience of strong emotions during treatment. Some patients may 
find psychotherapy embarrassing or anxiety-provoking, whether or not the treatment presses them to 
confront reminders of past traumas. A risk of this treatment is that it may be ineffective and that patients 
may not improve or even worsen. (2)Horses are physically strong and have the potential to cause bodily 
harm if safety precautions and instructions are not followed during equine encounters. 
Videotaping: Some patients may feel uncomfortable about the treatments being videotaped (necessary for 
supervision and treatment integrity checks). However, this will be a required procedure.
Audiotaping: Some patients may feel uncomfortable about the treatment sessions being audiotaped 
(necessary for supervision, integrity checks, and feedback following completion of the study). However, this 
will be a required procedure.
MRI Scanning: MRI scanning is not associated with any known medical risks, except for persons who have 
a heart pacemaker or have metal in their body (e.g. shrapnel or surgical prostheses) which may be affected 
by the magnet. Some people have reported sensations during MRI scans with the 1.5T magnet, such as 
“tingling” or “twitching” (or, very rarely, a painful sensation), which are caused by changes in the magnetic 
field. The MRI scanner also produces a loud noise. Some subjects become anxious and feel claustrophobic 
in the MRI scanner. Women of child-bearing age will be required to have a pregnancy urine test at the time 
of medical screening and on the day of the MRI scan. For women of child-bearing age, it will also be asked 
and it will be documented that they responded negatively (or procedure will not occur) to questioning on the 
MRI day (before the procedure is initiated) whether it is possible they may have become pregnant in the 
prior two week period. 
Describe procedures for minimizing risks
Interviews/assessments: Subjects will be informed that they may choose not to answer specific questions, 
and may stop the interview at any time if they are feeling uncomfortable. Trained evaluators will be 
sensitive to patient vulnerabilities, and every effort will be made to ensure patients’ comfort. 
All participants will be assessed with the HAM-D 17, and the BDI-II at intake, treatment mid-point (week 
4), and end of treatment (week 8), and at a 3-month follow-up. Participants will be assessed with the BDI-II 
at baseline as well and with the Columbia Veterans Center Suicide Risk Assessment at intake, treatment 
mid-point (week 4), and end of treatment (week 8). Any indication of elevated suicide risk during treatment 
will prompt an immediate discussion between the clinical and therapeutic teams, and clinical evaluation. If a 
participant is deemed to be at greater than minimal risk at any point during treatment, the following steps 
will be considered:
• Provision of contact information for emergency services (911, Anxiety Disorders Clinic pager, Veterans 
Crisis Line, NYC Mobile Crisis Team)
• Scheduling with ADC MD as soon as possible
• Completion of Safety Plan, copy of which is kept by patient
• Discussion of removal of means, including firearms

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• Removal from current protocol and enrollment within alternative treatment through the Columbia Veterans 
Research Center (IRB# 7218)
For those at high risk, the following will be considered based on clinical judgment:
• Referral to a high risk treatment program 
• Emergency room (voluntary)
• Emergency room (involuntary)
HAM-D 17 Scores between 15-25 at the eligibility assessment will prompt a clinical evaluation to address 
whether or not the patient is sufficiently stable to delay treatment for depression in order to participate in the 
study. If it is determined by the clinician that it would not be appropriate for the patient to participate in the 
study due to elevated levels of distress that warrant more immediate attention, the patient will be referred for 
empirically-validated treatment for depression within the Columbia Veterans Research Center (IRB #7218) 
(e.g. SSRI). Patients who are referred for immediate treatment may be offered the opportunity to be re-
evaluated for study participation at a later date as warranted. 
Trauma-Focused Equine-Assisted Therapy: (1) Therapists experienced in treating PTSD patients will assess 
this distress continually as part of treatment and will ask for additional evaluations or PI intervention when 
clinically appropriate. Every effort will be made to insure patients’ comfort during treatment, and patients 
will be withdrawn if needed. (2) Risk will be minimized in two ways: first, through careful monitoring and 
handling of horse behavior during treatment sessions by trained horse handlers and assistants. Second, 
horses will not be ridden at any point during the treatment, horse riding carries a greater risk of injury than 
interacting with horses on the ground.
Videotaping: The purpose of the videotaping will be explained, confidentiality will be respected, and tapes 
will be erased after the spot checks or following supervision. Informed consent for taping will be obtained.
Audiotaping: The purpose of the audiotaping will be explained, confidentiality will be respected, and tapes 
will be erased after the spot checks or following supervision. Informed consent for taping will be obtained.
MRI Scanning: Patients participating in the MRI scans will be screened by interview and questionnaire to 
determine the presence or absence of metallic objects, and informed that they cannot participate in the study 
if their body contains any paramagnetic metal other than standard dental work. Staff will be available for 
help and support if the subject feels anxious or claustrophobic in the MRI scanner and can stop the scan at 
the subject’s request. To reduce noise discomfort earplugs will be provided.
Other Procedures for Minimizing Risk:
1) Careful medical and psychiatric screening to identify patients for whom risk for potential adverse effects 
are elevated. Such patients will be excluded from the study. In such cases clinicians will follow the protocol 
for minimizing risks during interviews and assessments described above.
2) Patients with any of the following will be removed from research and treated openly or as clinically 
indicated: a) the occurrence of assaultive or illegal behavior; b) the occurrence of active suicidal ideation at 
any point during the trial as assessed by clinical interview; c) behaviors while intoxicated that are a danger 
to self or others.
3) Inclusion of psychoeducation about PTSD, the treatment process and memory triggers within the 
therapeutic framework.

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4) Careful monitoring of patients during pretreatment and study participation by experienced clinicians. 
Patients will see the same clinicians for each of their treatment visits.
6) Ability to remove any patient from the study who evidences significant clinical deterioration during 
treatment. Provisions will be made for appropriate clinical care of such patients at the Columbia Veterans 
Research Center (IRB #7218).
7) Patients failing to benefit from the study treatment will be discharged from the study and provided with 
appropriate clinical care based on weekly review with termination criteria 
8) All data will be coded and stored in locked files to insure confidentiality.
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All data collected (including audio-and videotape data) will be kept confidential and used for research 
purposes only. Patient charts will be kept in locked file cabinets identified by number rather than by name. 
Access to research records is restricted to research staff and Federal, State, and Institutional regulatory 
authorities. Electronic data will be protected by password access. No names of subjects will be recorded on 
any audio or video-recordings or written in any research instrument or tape. No subject’s identifying data 
will be published. Audio and video recordings will be stored for up to three years after which time they will 
be erased and properly destroyed.
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  
Direct Benefits to Subjects
All participants will receive a complete psychiatric evaluation, results of which will be communicated to the 
participants and their physician, at the participant’s request. PTSD symptoms may improve as a result of the 
EAT treatment. Participants will receive no direct benefits from the fMRI scans.
A potential benefit to society of this research is that the knowledge gained may provide future benefits for 
individuals with PTSD in improving understanding of PTSD treatments, and may improve future 
treatments.
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.

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All subjects will receive $100 for each evaluation visit (Baseline, Week 4, End of treatment, and Follow-
up).  Compensation will be mailed to the subject in the form of a check within 6 weeks of the completion of 
the baseline, week 4, end of treatment, and three month follow-up. Patients participating in the MRI scans 
will be compensated $175 for each scan. At the final treatment sessions, participants will also be given the 
boots worn during the study. Participants will be compensated up to a total of 400$ for participation in the 
study if they complete all evaluations. If participants are eligible for MRIs they would be compensated up to 
750$ (400$ for assessments, 350$ for both MRIs) for their participation in the study. 
References
References
1. Anestis, M.D., et al., Equine-Related Treatments For Mental Disorders Lack Empirical Support: A 
Systematic Review of Empirical Investigations. Journal of Clinical Psychology, 2014. 70(12): p. 1115-1132.
2. Blake, D.D., et al., The Development of a Clinician-Administered Ptsd Scale. Journal of Traumatic 
Stress, 1995. 8(1): p. 75-90.
3. Earles, J.L., L.L. Vernon, and J.P. Yetz, Equine-Assisted Therapy for Anxiety and Posttraumatic Stress 
Symptoms. Journal of Traumatic Stress, 2015. 28(2): p. 149-152.
4. Schultz, P.N., G.A. Remick-Barlow, and L. Robbins, Equine-assisted psychotherapy: a mental health 
promotion/intervention modality for children who have experienced intra-family violence. Health & Social 
Care in the Community, 2007. 15(3): p. 265-271.
5. Selby, A. and A. Smith-Osborne, A Systematic Review of Effectiveness of Complementary and Adjunct 
Therapies and Interventions Involving Equines. Health Psychology, 2013. 32(4): p. 418-432.
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