Research-Program Evaluation Report(November 1, 2019 – January 10, 2020)

Alternative Treatment Options for VeteransFlorida Department of Veterans’ Affairs, Grant #12503

Date of Submission: January 10, 2020

Submitted by: Kevin E. Kip, Ph.D., FAAAS, FAHADistinguished USF Health ProfessorCollege of Public Health, Population Health SciencesUniversity of South Florida13201 Bruce B. Downs Blvd., CPH, Room 2108Tampa, FL 33612-3805813-974-9266 (phone)kkip@usf.edu

Submitted to: Nicholas ScireFlorida Department of Veterans’ AffairsMary Grizzle BLDG, Room 311-K11351 Ulmerton RoadLargo, FL 33778-1630

Prepared by: Kevin E. Kip, Ph.D., FAAAS, FAHADistinguished USF Health ProfessorCollege of Public Health, Population Health SciencesUniversity of South Florida13201 Bruce B. Downs Blvd., CPH, Room 2108Tampa, FL 33612-3805813-974-9266 (phone)kkip@usf.edu

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TABLE OF CONTENTS

SECTION TITLE PAGE

1.0 Introduction 3

2.0 Program Evaluation/Performance Task Results 6

2.1 Development of the Project Website 6

2.2 Initial Literature Review on the 5 Alternative Treatment Modalities 6

2.3 Interim Analyses of Participating Organizations and Program Evaluation 21

Data Collected to Date

2.4 Estimated Return on Investment (ROI) 34

Appendix 1. Review of Controlled Trials of HBOT for Persons with 16

Post Concussive Symptoms and Mild TBI

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1.0 INTRODUCTION

This report provides a summary of performance for the project entitled “Alternative Treatment

Options for Veterans” during the period November 1, 2019 through January 10, 2020. As

background, The University of South Florida, College of Public Health (USF-COPH) is tasked,

in accordance with Florida Senate Bill 1518 and the Florida Department of Veterans’ Affairs

(FDVA), with evaluating “alternative” treatment options and related assessment data that are

currently being provided to and collected among Veterans in Florida through a range of non-

profit community-based organizations. The five alternative treatment options that are being

provided to Florida Veterans in the community, and are the subject of this evaluation project,

include: (i) Accelerated Resolution Therapy (ART); (ii) Equine Therapy; (iii) Service Animal

Training Therapy; (iv) Music Therapy; and (v) Hyperbaric Oxygen Therapy (HBOT). A brief

description of each alternative treatment option is provided below.

Per the terms of the contract between FDVA and USF-COPH, the evaluation of alternative

treatment options for Florida Veterans is restricted to the following conditions:

Participants included in the assessment must be a U.S. Veteran who has had a prior

diagnosis, by a health care practitioner, of service-connected Post-Traumatic Stress

Disorder (PTSD) and/or Traumatic Brain Injury (TBI).

Participants must have previously sought services for PTSD and/or TBI (does not need to

have been through the Veterans Administration).

A central component of the project is development and implementation of a rigorous,

standardized program evaluation system to be used in the evaluation of all five alternative

treatment options. For all Veterans who receive alternative treatment options and are evaluated for

program effectiveness, the schedule for evaluation is as follows:

Accelerated Resolution Therapy (ART):

Before receipt of services, immediately after receipt of services, and at 1, 3, and 6-month

follow-up

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Equine Therapy:

Before receipt of services, immediately after receipt of services, and at 1, 3, and 6-month

follow-up

Service Animal Training Therapy:

Before receipt of services at 4 times as listed below, and then at 1, 3, and 6-months

follow-up after integration with the service dog

At the time of pre-approval application submission

At the time of being approved for receipt of a service dog

At the time when a service dog has been located and matched for the Veteran

At the time of initial home integration with the service dog

Music Therapy:

Before receipt of services, immediately after receipt of services, and at 1, 3, and 6-month

follow-up

Hyperbaric Oxygen Therapy (HBOT):

Before receipt of services, after 20 treatment HBOT sessions (mid treatment),

immediately after receipt of services (40 HBOT sessions), and at 1, 3, and 6-month

follow-up

Measures of health status of veterans include mental health, physical health, and substance and

prescription medication use. A brief listing of these measures, which will be completed by

Veterans before receipt of services, after receipt of services, and at 1, 3, and 6-month follow-up

is provided below.

Perceived stress - Perceived Stress Scale (PSS)

PTSD symptoms - PTSD Checklist (PCL-5)

Anxiety, depression, and somatization - Brief Symptom Inventory (BSI-18)

Sleep quality - Insomnia and Sleep Quality Index

Resiliency - Connor-Davidson Resiliency Scale

Positive ideation (opposite of suicidal ideation) - UPPS-P Impulsive Behavior Scale,

Positive and Negative Suicidal Ideation Scale (PANSI)

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Substance and prescription medication use – Tobacco, Alcohol, Prescription Medication,

and Other Substance Use Tool (TAPS)

Recruitment of FL community-based organizations that serve Veterans are being proactively

sought, including with use of the graphic below.

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2.0 PROGRAM EVALUATION/PERFORMANCE TASK RESULTS

As the current performance period was brief (approximately 2 months), program evaluation and

performance tasks completed relate to establishing the infrastructure for the project as a whole,

as well as preliminary data collection. This included the following 4 primary activities and

deliverables:

(i) Development of the project website

(ii) Initial literature review on the 5 alternative treatment modalities

(iii) Interim analyses of participating organizations and program evaluation data collected

to date

(iv) Estimate of Return on Investment (ROI) for veterans enrolled in the alternative

treatment service programs

2.1 Development of the Project Website. The project website has been developed with

additional content being added. The website is located at:

https://atovfl.wordpress.com

2.2 Initial Literature Review on the 5 Alternative Treatment Modalities. The text that follows

provides the initial literature review on the 5 alternative treatment options for veterans being

evaluated.

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Accelerated Resolution Therapy (ART)

Brief Description: Accelerated Resolution Therapy is an exposure-based “mind-body” therapy

that has been shown to be successful in the treatment of PTSD and related comorbidities.[1-4]

Each therapy session involves 4 primary steps that include: (i) Relaxation and Orientation (i.e.

focusing on and reducing body sensations); (ii) Imaginal Exposure (i.e. “visualizing” the

previous traumatic event from beginning to end); (iii) Imagery Rescripting (imagining a new,

preferred way to visualize the original traumatic experience); and (iv) Assessment and Closeout

(i.e. verifying recall of the original memory without significant distress and easy shift to the

rescripted version).[5, 6] In all four steps, patients are directed by the clinician to perform

repeated sets of horizontal smooth pursuit eye movements,[7] by following the clinician's hand,

which is moving horizontally from side to side in close proximity to the patient's face.

Beneficial features of the ART protocol include: (i) short treatment duration; (ii) no

homework or outside work required; (iii) no requirement to write or verbalize details of

traumatic experiences; and (iv) being solution oriented to change the way that memories and

images are stored in the brain through a process known as memory reconsolidation.[6, 8, 9] In

treatment studies to date, the ART protocol has shown clinically and statistically meaningful

reductions in symptoms of PTSD in approximately 70% of cases treated, and in an average of

approximately 4 treatment sessions.[10]

In brief, there have been four studies completed on ART for the treatment of

psychological trauma, as recently summarized.[10] All resulted in peer-reviewed publications,

including multiple case series and one randomized clinical trial. The first study, conducted

principally among adult civilians, used an observational prospective cohort study design (n = 75)

with clinical assessments made pre-ART, post-treatment completion, and at 2- and 4-month

follow-up.[2] This study, with a median of 3 treatment sessions, showed a 45% reduction in

symptoms of PTSD at 2-month follow-up after treatment completion with ART.[2]

The second study was a randomized controlled trial among 57 U.S. service members and

veterans, with clinical assessments made pre-ART, post-treatment completion, and at 3-month

follow-up.[3] In this trial, ART was compared with an attention control condition that consisted

of two sessions of fitness or career counseling. This study showed that 65% of veterans treated

with ART with a mean of 3.7 sessions experienced clinically and statistically meaningful

reductions in symptoms of PTSD.[3]

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The third study was a large cohort study among U.S. service members and veterans that

used an observational prospective design (n = 160) with clinical assessments made pre-ART,

post-treatment completion, and at 6-month follow-up.[1] In this study, 75% of veterans treated

with ART, with a mean of 4 sessions, including some veterans who were homeless, experienced

clinically and statistically meaningful reductions in symptoms of PTSD.[1]

The fourth study was conducted among a small cohort of female veterans (n=6) with a

history of military sexual trauma.[11] This study showed, in a mean of 4 treatment sessions, a

46% reduction in symptoms of PTSD after treatment completion with ART.[11]

Additional publications of ART have shown substantial reductions in pain,[12] including

neuropathic pain,[13] reductions in symptoms of obsessive compulsive disorder,[14] and

effective treatment of symptoms of PTSD for veterans with a history of traumatic brain injury

and those who served in the US Special Forces.[5] In addition, a recent clinical trial of ART for

treatment of prolonged complicated grief has been completed (Clinical Trials.gov:

NCT03484338), and favorable results will be published in the near future. In aggregate, these

studies show ART as a brief, effective treatment for symptoms of PTSD and related

comorbidities.

Helpful Links: Some helpful links on ART include:

4-minute video overview of ART:

http://www.youtube.com/watch?

v=w_bi0eW_WsU&feature=share&list=UUzZzLGbYx9OHlCjN5TTSv4w&index=1

3-minute video overview of ART:

https://www.youtube.com/watch?v=2_EOL3VJ3Sw

17-minute TEDx talk on ART

https://www.youtube.com/watch?v=vP7dx03arxI

ART Websites:

www.artworksnow.com

https://artherapyinternational.org/

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Equine Therapy

Brief Description: Equine Assisted Therapy (EAT) encompasses a range of treatments,

including therapeutic horseback riding (THR) and others, each of which involve activities with

horses to enhance physical and mental health.[15] Riding skills, grooming and working with

the horse at ground level, face-to-face, enable acquisition of effective learning and coping

strategies.[16] Importantly, these skills directly affect one’s emotional state and contribute to

raising one’s sense of self-worth, self-efficacy and control of the horse and body during riding.

In this regard, EAT helps to increase the capacity to control anger, anxiety, and relationships.

[16] Therapeutically, the horse identifies identifies and responds to the moods, emotions and

body language of those around it, thus creating a mirror for human beings.[15, 17, 18]

The evidence base for EAT as a treatment modality for PTSD and related comorbidities

is limited. An EAT program that included 2-hour sessions for 6 weeks found significant

reductions in symptoms of PTSD and anxiety among persons who had experienced rape or

serious accidents.[15] A second study of 39 combat veterans who completed an 8-week study of

THR reported improvements in PTSD symptoms, social functioning and reduced interference

of emotions in daily activities.[19] Similarly, a 6-week study of THR among US post-

deployment veterans with PTSD or PTSD and TBI showed decreased PTSD symptoms,

improved social functioning and reduced interference of emotions in daily activities.[20] These

indications of efficacy have led to development of an evidence-based protocol of THR for US

Army Veterans with PTSD,[21] and a recent systematic review of EAT interventions for

veterans with service-related health conditions has been published.[22]

Helpful Links: Some helpful links on EAT include:

5-minute video of veterans describing the benefits of EAT

https://www.youtube.com/watch?v=Z7EedCwJ4ww

8-minute video on the EAGALA Model for Equine-Assisted Psychotherapy for military

personnel

https://www.youtube.com/watch?v=boVatiz-55g

Service Animal Training Therapy

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Brief Description: For the purpose of this evaluation, service animal training therapy is restricted

to service dogs that are trained to perform disability-specific tasks for their owners and are

increasingly used by veterans with combat-related physical impairments.[23] Psychiatric service

dogs are distinguished from emotional support, therapy, or companion dogs by specifically being

trained to perform a variety of commands relevant to the psychiatric needs of the individual, and

thus are legally allowed public access under the Americans with Disabilities Act.[24, 25]

These psychiatric service dogs are thought to mitigate PTSD symptomology by instilling

a sense of confidence, safety, and independence in the veteran on a day-to-day basis. Specific

tasks can range from responding to and distracting a veteran from panic or emotional distress,

“watching” their back in public, and waking them up from nightmares. PTSD service dogs may

also alleviate anxious arousal/hypervigilance, avoidance, and feelings of isolation and

detachment from others.[26-28] For example, qualitative evidence suggests that PTSD service

dogs can confer unique benefits to military veterans that address PTSD symptomology,

especially hyperarousal.[26, 29]

In addition, use of service dogs has been associated with decreased use of pain medication and

improved emotional regulation,[30] as well as reduced medication and suicidal impulses.[31, 32]

Still, despite much of the evidence being anecdotal and retrospective reports, along with

considerable media attention (e.g. [33], recent systematic reviews of the literature on Animal-

Assisted Intervention (AAI) for PTSD reveal that there is a notable absence of peer-reviewed,

empirical studies of the efficacy of service dogs for alleviating PTSD symptoms.[17, 34]

Nonetheless, two recent studies employing controlled designs and using extensive and

innovative outcome measures provide insight into service dog programs for military veterans and

potential benefit in reducing symptoms of PTSD.[35] One non-randomized efficacy trial

compared post-9/11 veterans diagnosed with PTSD who had received and trained a service dog

in addition to participating in usual care, to a waitlist group of similar veterans who received

only usual care.[36] This study concluded that veterans with their trained service dogs had

clinically meaningful improvements in their PTSD symptomology, social functioning, and better

quality of life compared to veterans who only received usual care.[36]

A second recent two-group non-randomized study compared the cortisol levels (a

measure of stress response) and symptom-related behaviors of veterans with PTSD who had a

service dog to a group of comparable veterans on a waitlist.[37] Investigators reported that,

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compared to similar veterans on a waitlist, the veterans who had service dogs had improved

levels of salivary cortisol awakening response (CAR), reflecting lower stress and described

lower hyperarousal and PTSD symptomology and better psychosocial well-being overall.[37]

More recently, Whitworth and colleagues compared a 14-week service dog program for

veterans diagnosed with PTSD (n=15) versus 15 similar veterans in a waitlist control group

(n=15). Participants who completed the service dog training program demonstrated significant

decreases in posttraumatic symptomatology, intra/interpersonal difficulties associated with

psychological trauma, and in disabilities secondary to their PTSD.[37] In aggregate, empirical

data to date indicate that service dog programs may be efficacious for reducing symptoms of

PTSD and related comorbidities, particularly among military personnel, yet additional rigorous

empirical studies are needed.

Helpful Links:

VA Program Provides Service Dogs to Veterans with Mental Health Issues

https://www.military.com/benefits/2017/05/19/va-service-dogs-mental-health.html

VA Service Dog Fact Sheet - Veterinary Health Benefits for Mental Health Mobility Service

Dogs

https://www.va.gov/HEALTHPARTNERSHIPS/docs/CCIServiceDogFactSheet.pdf

5-minute video on Service Dogs Helping Veterans with PTSD

https://www.youtube.com/watch?v=JaVKGrWakIg

Music Therapy

Brief Description: Music therapy has been employed as a therapeutic intervention to facilitate

healing across a variety of clinical populations. A music therapist offers a tailored structure to

shape and develop the course of therapy. For instance, the patient can create his/her own music

with the therapist’s guidance as a way of expressing emotions [38], or the therapist can present

the patient with a song and encourage him/her to sing along or introduce their own words. The

structure and protocol for music therapy can vary widely across a range of instruments,

mediums, and methods of expression.[39] Group or communal music therapy is intended to

bring together individuals with a shared experience (e.g. military service, communal trauma) to

work together via group discussion or improvisation.[40] (DeNora, 2002).

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Music therapy in the United States must be practiced by accredited music therapists

certified by the Certification Board and can serve as an adjunctive therapeutic program or stand

on its own (AMTA).[41] Mental health providers must refer clients to music therapists if they

want to incorporate music therapy into treatment. The therapist then formulates a treatment plan

that can involve musical improvisation, listening exercises, singing, music making, the playing

of an instrument, and a discussion of the emotions conveyed through a piece of music heard by

the patient.[42]

Two recent studies have suggested that music therapy can improve PTSD or TBI for

military service members through songwriting and a variety of interventions.[43, 44] This

includes the potential to increase the neuroplasticity of the brain and rebuild damaged neural

communications, and listening with a consistent tempo also regulate breath and heart beat

pattern.[44] A randomized-controlled trial recruited 17 patients with PTSD from a specialized

clinic that provided Trauma-Focused CBT. Of those eligible, half were randomly assigned to

receive an additional ten weeks of music therapy consisting of one, one-hour session of group

improvisational instrumental therapy provided weekly. The control group was not offered music

therapy or any other intervention. Compared to the control group, patients in the music therapy

condition demonstrated a significantly greater reduction in posttraumatic stress symptoms.[45]

A non-controlled pre-post examination of music therapy for military veterans with PTSD

looked at the efficacy of group drumming therapy among six male subjects aged 20–23 who had

experienced traumatic events during military service and had a diagnosis of PTSD. They

participated in group drumming music therapy for 16 weekly 90-minute sessions. Therapist

observations indicated a significant reduction of specific symptoms including isolation, lack of

connectedness, avoidance of traumatic memories, rage, and anxiety.[39]

A small pilot study conducted at the Zablocki VA Medical Center in Milwaukee, WI

consisted of Veterans receiving an hour of individual guitar training each week and a weekly

group instruction session. Results showed a positive benefit in relieving PTSD symptoms as a

result of the intervention. In addition, findings suggest that the music therapy was effective in

reducing depression symptoms and improving health-related quality of life.[46]

From a theoretical perspective, music therapy may potentially alleviate symptoms of

PTSD. Still, with respect to the use of music therapy for military populations, integrated

examination of the theoretical mechanisms and processes with empirical evidence for music

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therapy for PTSD and related comorbidities is limited.[41] For example, music may address

emotion dysregulation associated with intrusive memories that leave individuals feeling triggered

and distressed.[47] Negative feelings such as anger, guilt, shame, fear, and anxiety may be

addressed by music’s ability to activate reward pathways in the brain and suppress the release of

stress hormones.[48] Similarly, listening to and playing music have also been shown to reduce

the production of the stress hormone cortisol.[49]

In aggregate, music therapy appears to be a promising alternative treatment options for

military personnel suffering from symptoms of PTSD and related comorbidities. Additional

empirical evidence is required to fully assess the potential benefits of music therapy.

Helpful Links:

Music Therapy and Military Populations

https://www.musictherapy.org/research/music_therapy_and_military_populations/

13-minute video on Musical healing for TBI and PTSD

https://www.brainline.org/article/musical-healing-tbi-and-ptsd

Hyperbaric Oxygen Therapy (HBOT)

Brief Description: Administration of hyperbaric oxygen therapy (HBOT) involves breathing high

levels of medical grade oxygen, usually 100% oxygen, at a pressure at least 1.4 times greater

than the atmospheric absolute pressure at sea level (1 atmosphere absolute or ATA, which is

equivalent to 760 mm Hg partial pressure of oxygen). Of note, in normal air, the oxygen level is

only around 21%. The intent of HBOT is to increase the oxygenation of the patient’s blood and

tissues to supraphysiological levels.[50] The partial pressure of oxygen increases proportionally

with an increase in the hyperbaric chamber compression pressure. One theory proposed to

support the use of HBOT in TBI patients is that exposure to HBOT allows functionally

retrievable neurons adjacent to severely damaged or dead neurons to return to more normal

function by reactivating metabolic or electrical pathways.[51] In addition, HBOT has been

proposed as a treatment option for PTSD. The rationale for this is based, in part, by the fact that

neurobiological characteristics of PTSD show multiple regions of the brain being affected. These

include hippocampal atrophy and altered activity of the insular cortex, as well as hypoactivity of

the hypothalamic–pituitary–adrenal axis.[52] In addition, for treatment of symptoms of both TBI

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and PTSD, potential beneficial mechanisms associated with HBOT include stem cell migration,

reduced inflammation, alterations in cerebral blood flow, and increased angiogenesis and

neurogenesis.[53, 54] While treatment protocols differ, a common regimen of treatment with

HBOT consists of approximately 40 daily sessions within the hyperbaric chamber, with sessions

lasting 30 minutes to 2 hours in length.

The empirical evidence for the effectiveness of HBOT in the treatment of symptoms of

TBI and/or PTSD is mixed, and highly controversial. Several peer-reviewed scientific studies

have reported beneficial effects of HBOT in subjects with chronic residual effects of moderate to

severe TBI.[55-59] Similarly, positive effects of HBOT have been reported in significantly

reducing symptoms of PTSD among veterans with concomitant mild to moderate TBI/post-

concussion syndrome (PCS),[60] However, the randomized controlled trial design is considered

the gold-standard in terms of methodological rigor and the ability to draw causal inferences from

evaluation of treatment approaches. In this regards, several randomized controlled clinical trials

have been performed using HBOT to treat symptoms of TBI and PTSD with varied results that

are open to interpretation. A summary of major trials is provided in Appendix 1.

In brief, 5 double blind randomized “sham-controlled” trials have been recently

published.[61-65] In these trials, ATA pressures varied considerably between the “active” and

“sham-controlled” treatment arms, and one of the trials included a “no-chamber” control

regimen. In aggregate, these trials show small to medium effects in terms of reductions in

symptoms of PCS and TBI, and at varying doses of oxygenation. Of note, the Miller (2015) trial

reported overall larger reductions in symptoms of PCS and TBI in the “sham” condition (1.2

ATA), as compared to the presumed therapeutically “active” condition (1.5 ATA).[63] Both

groups performed better than the no chamber condition. Thus, the trial data tend to show

comparable therapeutic results between the “active” and “sham” treatment regimens. In 2018,

investigators from the VA Evidence-based Synthesis Program (ESP) conducted an independent

and objective re-analysis of 16 randomized controlled trials and found inconclusive evidence of

HBOT’s benefits at least for mild TBI and PTSD, no obvious indication that bias led to flaws in

VA/DoD randomized controlled trials, and that current evidence does not clearly support any one

argument over another for or against HBOT.[66]

With respect to findings from the above referenced “sham-controlled” randomized trials,

challenges from the scientific community have been vocal and extensive. In brief, it has been

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postulated that the hyperbaric treatments in the sham arms of the trials (such as at 1.2 ATA) were

in fact medicinal, including potentially increasing (significantly) the amount of dissolved oxygen

in the blood and simultaneously inducing cascades of positive metabolic changes and gene

activations.[67] Thus, critics of the results of the sham-controlled” randomized trials argue that

the design employed was actually dose response (i.e. lower versus higher levels of oxygenation)

rather than “placebo.” On the other hand, military PTSD scholars have suggested that the

chamber treatment environment, in and of itself (i.e. irrespective of oxygen level) is therapeutic,

[68], possibly due to factors such as enhanced expectancy, conditioning, the authoritative context

of care, and social reinforcement.[69] They also suggest the possibility that daily ritual

visitations during 8 to 10 weeks of treatment foster organic narrative processes between study

participants and with their compassionate staff members, consistent with core components of

effective PTSD and depression psychotherapy.[70] Despite this controversy, the amount of

pressure needed to potentially induce positive clinical benefits in both TBI and PTSD patients is

unknown. Therefore, it is conceivable that even at small pressures, HBOT may offer significant

clinical benefit to military personnel with a history of TBI and/or PTSD.(e.g.[65]).

Helpful Links: Some helpful links on HBOT include:

VA Health Services Research and Development: Evidence Brief: Hyperbaric Oxygen Therapy

(HBOT) for Traumatic Brain Injury and/or Post-traumatic Stress Disorder

https://www.hsrd.research.va.gov/publications/esp/hbot.cfm

5-minute video of VA to offer HBOT for some veterans with PTSD and TBI

https://www.youtube.com/watch?v=zoGyt9C5hlA

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Appendix 1. Review of Controlled Trials of HBOT for Persons with Post Concussive Symptoms and Mild TBI

Ref #

Author / Year

Design Population HBOT schedule

Groups Primary Outcome

Secondary Outcomes

1 Wolf / 2012

Double blind randomized sham controlled RCT

Service members with combat-related mTBI

30 daily sessions

(1) 100% oxygen at 2.4 ATA (n=25)

PCS and cognitive testing at baseline and 6 weeks after intervention

PTSD Symptoms (PCL-M)

(2) 21% oxygen at 1.3 ATA (n=25)

Main Results Both groups showed some improvement on Impact scale symptoms including headache, falling asleep, and better emotional health. Improvements were generally similar between the 2 groups. PCL-M (PTSD) showed drops of 17.0% and 16.8% in the control and HBOT groups, respectively.

Comments Engaging in 30 chamber sessions appears to result in modest improvements in selected physical symptoms and emotional health, including modest reduction in symptoms of PTSD. These improvements appear to occur irrespective of the dose of oxygen, and therefore, cannot rule out the possibility of significant benefit attributed to expectation (placebo).

2 Cifu / 2014

Double blind randomized sham controlled RCT

Service members with combat-related mTBI

40 daily sessions

(1) 100% oxygen at 2.0 ATA (n=21)

Post-concussion Symptoms

PTSD Symptoms

(2) 75% oxygen at 2.0 ATA (n=18)(3) 10.5% oxygen at 2.0 ATA (n=21)

Main Results Nominal 12.5% reduction in PCS in 100% oxygen group. No reduction in PCS in 75% or 10.5% oxygen groups. Differences with 100% oxygen group not significant.Nominal 14.1% reduction in PCL score in 100% oxygen group. Minimal reduction in PCL in 75% or 10.5% oxygen groups. Differences with 100% oxygen group not significant.

Comments Minimal evidence of therapeutic effect of HBOT at 100% oxygen. No effect of HBOT at 75% oxygen or 10.5% oxygen (sham).Mean drop in PCL of 6.9 points in 100% oxygen group is of nominal clinical relevance.

3 Cifu / 2014

Double blind randomized sham controlled RCT

mTBI within past 3-months to 3 years, diagnosis of PCS, stable

40 daily sessions

(1) 100% oxygen at 2.0 ATA (n=19)

Post-concussion Symptoms

Depression, memory, cognition, life satisfaction(2) 75%

oxygen at 2.0 ATA (n=21)(3) 10.5% oxygen at 2.0 ATA (n=21)

Main Results No statistical difference in PCS between groups, including pre versus post and at 3-month follow-up.No statistical difference in any secondary outcome between groups, including pre versus post and at 3-month follow-up.

Comments Poor analysis that relies on statistical testing and does not report absolute or magnitude of treatment-related changes. Still, no evidence of efficacy of HBOT at 100% or 75% oxygen.

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4 Walker / 2014

Same as Cifu (ref 2)

Same as Cifu (ref 2)

Same as Cifu (ref 2)

(1) 100% oxygen at 2.0 ATA (n=21)

Psychomotor function (e.g. postural stability and balance)

Cognitive function (e.g. executive function, working memory)

(2) 75% oxygen at 2.0 ATA (n=18)(3) 10.5% oxygen at 2.0 ATA (n=21)

Main Results No immediate post-compression beneficial effect of HBOT on cognitive or psychomotor performance at 1.5 to 2.0 ATA O2 as compared to sham. Within group changes in all outcome measure were very small to small, with most noticeable differences in some measures of cognitive attention and executive function generally observed across all groups.

Comments Minimal evidence of therapeutic effect of HBOT at 100% oxygen in terms of psychomotor performance and cognitive function.

5 Miller / 2015

Double blind randomized sham controlled RCT

Symptoms of mTBI for at least 4 months

40 daily sessions

(1) 100% oxygen at 1.5 ATA (n=24)

Post-concussion Symptoms

PTSD checklist and Neurobehavioral Symptom Inventory

(2) 100% oxygen at 1.2 ATA (n=25)(3) No chamber (n=23)

Main Results HBOT (1.5 ATA) and sham (1.2 ATA) showed significant reduction in PCS total score of 16.4% and 23.2%, respectively. The No chamber group did not improve on Sx of PTSD or NSI. Significant reductions in PCL and NSI scores were almost twice as large in sham (1.2 ATA) group compared to HBOT (1.5 ATA) group.Sham group also showed substantial reductions in depression, anxiety, and pain whereas HBOT group (1.5 ATA) did not show meaningful improvements. Sham group also showed better results in terms of physical and emotional functioning.

Comments Unexpectedly, postulated sham condition of 1.2 ATA seemed to perform better than conventional 1.5 ATA regimen. This occurred across a range of outcome measures. Expectancy and daily routine effects of being in the chamber cannot be estimated with respect to comparison against the no chamber group.

References (Initial Literature Review)

1. Kip, K.E., et al., Evaluation of brief treatment of symptoms of psychological trauma among veterans residing in a homeless shelter by use of Accelerated Resolution Therapy (ART). Nursing Outlook, 2016. 64: p. 411-423.

2. Kip, K.E., et al., Brief treatment of symptoms of post-traumatic stress disorder (PTSD) by use of Accelerated Resolution Therapy (ART). Behavioral Sciences, 2012. 2(2): p. 115-134.

3. Kip, K.E., et al., Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD). Military Medicine, 2013. 178: p. 1298-1309.

4. Kip, K.E., et al., Brief treatment of co-occurring post-traumatic stress and depressive symptoms by use of accelerated resolution therapy. Frontiers in Psychiatry, 2013. 4: p. 1-12.

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5. Kip, K.E., et al., The emergence of Accelerated Resolution Therapy (ART) for treatment of post-traumatic stress disorder (PTSD): A review and new subgroup analyses. Counselling and Psychotherapy Research, 2019. 19: p. 117–129.

6. Kip, K.E., et al., Case report and theoretical description of accelerated resolution therapy (ART) for military-related post-traumatic stress disorder. Military Medicine, 2014. 179: p. 31-37.

7. Purves, D., G.J. Augustine, and D. Fitzpatrick, Neuroscience. Second ed. 2001, Sunderland, MA: Sinauer Associates.

8. Monfils, M.H., et al., Extinction-reconsolidation boundaries: key to persistent attenuation of fear memories. Science, 2009. 324: p. 951-955.

9. Waits, W., M. Marumoto, and J. Weaver, Accelerated resolution therapy (ART): a review and research to date. Current Psychiatry Reports, 2017. 19(3): p. 18.

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11. Rossiter, A.G., et al., Accelerated resolution therapy for women veterans experiencing military sexual trauma related post-traumatic stress disorder. Annals of Psychiatry and Mental Health, 2017. 5: p. 1108.

12. Kip, K.E., et al., Accelerated resolution therapy (ART) for treatment of pain secondary to combat-related post-traumatic stress disorder (PTSD). European Journal of Psychotraumatology, 2014. 5: p. 24066.

13. Kip, K.E., et al., Pilot study of Accelerated Resolution Therapy for treatment of chronic refractory neuropathic pain. Alternative and Complementary Therapies, 2016. 22(6): p. 243-250.

14. Schimmels, J. and W. Waits, A Tale of Two Compulsions - Two Case Studies Using Accelerated Resolution Therapy (ART) for Obsessive Compulsive Disorder (OCD). Mil Med, 2019. 184(5-6): p. e470-e474.

15. 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: p. 149–152.

16. Shelef, A., et al., Equine assisted therapy for patients with post traumatic stress disorder: A case series study. Military Medicine, 2019.

17. O’Haire, M.E., N.A. Guérin, and A.C. Kirkham, Animal-assisted intervention for trauma: a systematic literature review. Frontiers in Psychology, 2015. 6: p. 1121.

18. Van Der Kolk, B., The Body Keeps the Score, Brain, Mind & Body in the Healing of Trauma. 2014, New York, NY: Viking.

19. Lanning, B.A., et al., Using Therapeutic Riding as an Intervention for Combat Veterans: An International Classification of Functioning, Disability, and Health (ICF) Approach. Occupational Therapy in Mental Health, 2017. 33(3): p. 259-278.

20. Johnson, R.A., et al., Effects of therapeutic horseback riding on post-traumatic stress disorder in military veterans. Mil Med Res, 2018. 5(1): p. 3.

21. Martz, K.C., An evidence-based protocol of equestrian therapy in veterans with posttraumatic stress disorder: A best practice approach, in Nursing. 2014, University of Arizona.

22. Kinney, A.R., et al., Equine-assisted interventions for veterans with service-related health conditions: a systematic mapping review. Military Medical Research, 2019. 6(1): p. 28.

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23. Foreman, K. and C. Crosson, Canines for combat veterans: The National Education for Assistance Dog Services. U.S. Army Medical Department Journal, 2012. April-June: p. 61-62.

24. Kruger, K. and J. Serpell, Animal-assisted interventions in mental health: Definitions and theoretical foundations, in Handbook on animal-assisted therapy: Theoretical foundations and guidelines for practice, A.H. Fine, Editor. 2010, Academic Press: San Diego. p. 33-48.

25. Tedeschi, P., A. Fine, and J. Helgeson, Assistance animals: Their evolving role in psychiatric service applications, in Handbook on animal-assisted therapy: Theoretical foundations and guidelines for practice, A.H. Fine, Editor. 2010, Academic Press: San Diego. p. 421-438.

26. Taylor, M.F., M.E. Edwards, and J.A. Pooley, “Nudging them back to reality”: Toward a growing public acceptance of the role dogs fulfill in ameliorating contemporary veterans’ PTSD symptoms. Anthrozoös, 2013. 26(4): p. 593–611.

27. Yeager, A.F. and J. Irwin, Rehabilitative canine interactions at the Walter Reed National Military Medical Center. US Army Med Dep J, 2012: p. 57-60.

28. Yount, R., et al., The role of service dog training in the treatment of combat-related PTSD. Psychiatric Annals, 2013. 43(6): p. 292–295.

29. Crowe, T.K., et al., Veterans transitioning from isolation to integration: a look at veteran/service dog partnerships. Disabil Rehabil, 2018. 40(24): p. 2953-2961.

30. Thorne, K.L., E.J. Devlin, and K.M. Dingess, Service dogs for veterans with PTSD: Implications for workplace success. Career Planning & Adult Development Journal,, 2017. 33(2): p. 36-48.

31. Kloep, M.L., R.H. Hunter, and S.J. Kertz, Examining the effects of a novel training program and use of psychiatric service dogs for military-related PTSD and associated symptoms. Am J Orthopsychiatry, 2017. 87(4): p. 425-433.

32. Yarborough, B.J.H., et al., Benefits and challenges of using service dogs for veterans with posttraumatic stress disorder. Psychiatr Rehabil J, 2018. 41(2): p. 118-124.

33. Arehart-Treichel, J., Guide dogs for the mind ease path through mental illness. Psychiatric News, 2010. 45: p. 14-28.

34. Krause-Parello, C.A., S. Sarni, and E. Padden, Military veterans and canine assistance for post-traumatic stress disorder: A narrative review of the literature. Nurse Educ Today, 2016. 47: p. 43-50.

35. Whitworth, J.D., D. Scotland-Coogan, and T. Wharton, Service dog training programs for veterans with PTSD: results of a pilot controlled study. Soc Work Health Care, 2019. 58(4): p. 412-430.

36. O'Haire, M.E. and K.E. Rodriguez, Preliminary efficacy of service dogs as a complementary treatment for posttraumatic stress disorder in military members and veterans. J Consult Clin Psychol, 2018. 86(2): p. 179-188.

37. Rodriguez, K.E., et al., The effect of a service dog on salivary cortisol awakening response in a military population with posttraumatic stress disorder (PTSD). Psychoneuroendocrinology, 2018. 98: p. 202-210.

38. Hurt-Thaut, C., Clinical practices in music therapy, in The Oxford Handbook of Music Psychology, S.C. Hallam, I., Thaut, M., Editor. 2009, Oxford University Press: New York, NY.

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39. Bensimon M, Amir D, and W. Y., Drumming through trauma: Music therapy with post-traumatic soldiers. The Arts in Psychotherapy, 2008. 35: p. 34–48.

40. Vaillancourt, G., Music therapy: A community approach to social justice. The Arts in Psychotherapy, 2012. 39(3): p. 173-178.

41. Landis-Shack, N., A.J. Heinz, and M.O. Bonn-Miller, Music Therapy for Posttraumatic Stress in Adults: A Theoretical Review. Psychomusicology, 2017. 27(4): p. 334-342.

42. Bonde, L. and T. Wigram, A comprehensive guide to music therapy: Theory, clinical practice, research, and training. 2002, London, England: Jessica Kingsley Publishers.

43. Bradt, J., J. Biondo, and R. Vaudreuil, Songs created by military service members in music therapy: A retrospective analysis. Arts in Psychotherapy, 2019. 62: p. 19-27.

44. Bronson, H., R. Vaudreuil, and J. Bradt, Music Therapy Treatment of Active Duty Military: An Overview of Intensive Outpatient and Longitudinal Care Programs. Music Therapy Perspectives, 2018. 36(2): p. 195-206.

45. Carr, C., et al., Group music therapy for patients with persistent post-traumatic stress disorder--an exploratory randomized controlled trial with mixed methods evaluation. Psychol Psychother, 2012. 85(2): p. 179-202.

46. Development, V.H.S.R. Music Therapy Program Helps Relieve PTSD Symptoms. 2014 January 3, 2020]; Available from: https://www.hsrd.research.va.gov/news/research_news/music-010614.cfm.

47. S., V., Music therapy and the treatment of trauma-induced dissociative disorders. The Arts in Psychotherapy, 1993. 20(3): p. 243–251.

48. Chanda, M.L. and D.J. Levitin, The neurochemistry of music. Trends Cogn Sci, 2013. 17(4): p. 179-93.

49. Wise, R.A., Dopamine, learning and motivation. Nat Rev Neurosci, 2004. 5(6): p. 483-94.

50. Gesell, L.B., Hyperbaric Oxygen Therapy Indications: The Hyperbaric Oxygen Therapy Committee Report. 12th ed. 2008: Durham, NC.

51. Neubauer, R.A., S.F. Gottlieb, and R.L. Kagan, Enhancing “idling” neurons. Lancet, 1990. 335: p. 542.

52. Whitaker, A.M., N.W. Gilpin, and S. Edwards, Animal models of post-traumatic stress disorder and recent neurobiological insights. Behav Pharmacol, 2014. 25(5-6): p. 398-409.

53. Ding, Z., et al., Hyperbaric oxygen therapy in acute ischemic stroke: a review. Interv Neurol, 2014. 2(4): p. 201-11.

54. Liu, W., et al., Application of medical gases in the field of neurobiology. Med Gas Res, 2011. 1(1): p. 13.

55. Golden, Z., C.J. Golden, and R.A. Neubauer, Improving neuropsychological function after chronic brain injury with hyperbaric oxygen. Disabil Rehabil, 2006. 28(22): p. 1379-86.

56. Golden, Z.L., et al., Improvement in cerebral metabolism in chronic brain injury after hyperbaric oxygen therapy. Int J Neurosci, 2002. 112(2): p. 119-31.

57. Hardy, P., et al., Pilot case study of the therapeutic potential of hyperbaric oxygen therapy on chronic brain injury. J Neurol Sci, 2007. 253: p. 94-105.

58. Neubauer, R.A., S.F. Gottlieb, and N.H. Pevsner, Hyperbaric oxygen for treatment of closed head injury. South Med J, 1994. 87(9): p. 933-6.

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59. Wright, J.K., et al., Case report: Treatment of mild traumatic brain injury with hyperbaric oxygen. Undersea Hyperb Med, 2009. 36(6): p. 391-9.

60. Harch, P.G., et al., A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma, 2012. 29(1): p. 168-85.

61. Cifu, D.X., et al., The effect of hyperbaric oxygen on persistent postconcussion symptoms. J Head Trauma Rehabil, 2014. 29(1): p. 11-20.

62. Cifu, D.X., et al., Hyperbaric oxygen for blast-related postconcussion syndrome: three-month outcomes. Ann Neurol, 2014. 75(2): p. 277-86.

63. Miller, R.S., et al., Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med, 2015. 175(1): p. 43-52.

64. Walker, W.C., et al., Randomized, Sham-Controlled, Feasibility Trial of Hyperbaric Oxygen for Service Members With Postconcussion Syndrome: Cognitive and Psychomotor Outcomes 1 Week Postintervention. Neurorehabilitation and Neural Repair, 2014. 28: p. 420-432.

65. Wolf, G., et al., The effect of hyperbaric oxygen on symptoms after mild traumatic brain injury. J Neurotrauma, 2012. 29(17): p. 2606-12.

66. Peterson, K., et al., Evidence Brief: Hyperbaric Oxygen Therapy (HBOT) for Traumatic Brain Injury and/or Post-traumatic Stress Disorder. 2018: Portland, OR.

67. Mozayeni, B.R., et al., The National Brain Injury Rescue and Rehabilitation Study - a multicenter observational study of hyperbaric oxygen for mild traumatic brain injury with post-concussive symptoms. Med Gas Res, 2019. 9(1): p. 1-12.

68. Hoge, C.W. and W.B. Jonas, The ritual of hyperbaric oxygen and lessons for the treatment of persistent postconcussion symptoms in military personnel. JAMA Intern Med, 2015. 175(1): p. 53-4.

69. Jonas, W.B., Reframing placebo in research and practice. Philos Trans R Soc Lond B Biol Sci, 2011. 366(1572): p. 1896-904.

70. Hoge, C.W., Interventions for war-related posttraumatic stress disorder: meeting veterans where they are. JAMA, 2011. 306(5): p. 549-51.

2.3 Interim Analyses of Participating Organizations and Program Evaluation Data Collected to

Date

As seen in the table that follows, a large cadre of services organizations have expressed interest

and agreed to participate in the project. Of these, the 3 highlighted organizations have collected

and submitted program evaluation data to date, as included in this report. They include:

Veterans Alternative, Quantum Leap Farm, and Guardian Angels Medical Services Dogs,

Inc. In addition, K9 Partners for Patriots have provided data under a separate effort that will be

included in future reports.

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Alternative Treatment Modality Provider Name Description of Services Street City & State Zip Primary Contact             

Accelerated Resolution Therapy            

Organization/Site (1) Veterans Alternative (Holiday)

Accelerated Wellness Program and Individualized ART sessions

1750 Arcadia Road Holiday, FL 34690 Patricia Fried, COO

Organization/Site (2) Veterans Alternative (Tampa) Individualized ART sessions 1905 N. Florida

Avenue Tampa, FL 33602 Patricia Fried, COO

Organization/Site (3) Camaraderie Foundation Individualized ART Sessions 2488 East Michigan

Street Orlando, FL 32806 Anna Tanzilla, Program Manager

Equine Therapy            

Organization/Site (1) Quantum Leap Farm

At E.A.S.E.- Facilitates learning through experiences with horses in specifically designed activities for emotional and relational growth

10401 Woodstock Rd Odessa, FL 33556 Edie Dopking, Ph.D.

Organization/Site (2) Inspire Equine Therapy Program

Offers Freedom Heroes and Equines Carriage Driving program for disabled veterans and first responders.

1743 Doncaster Road Clearwater, FL 33764 Melissa Yarbrough,

ED

Organization/Site (3) S.A.D.L.E.S Ranch

CODE H.O.R.S.E. program- This unique program developed by its founder is based on the outcomes from a two and one half year pilot research study designed and co-facilitated by Cher Myers, Founder of S.A.D.L.E.S. Ranch, Inc.

41025 Thomas Boat Landing Rd Umatilla, FL 32784 Cher Meyers, LCSW

Organization/Site (4)Emerald M. Theraputic Riding Center

P.E.A.C.E. Program for Veterans 4022 Goldsmith Rd Brooksville, FL 34602 Lisa Michaelangelo,

MPT

Service Animal

           

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Training Therapy

Organization/Site (1) Rescue 22

Pairs rescued working breeds with veterans of our United States Armed Forces and in some cases with those currently serving.

7006 229th Street East Bradenton, FL 34211 Angela Connor, VP

Organization/Site (2) K9 Partners for Patriots

Teaches qualifying veterans to train selected dogs and provides them based on their specific needs. The dog and the veteran work together from the onset through a 19-week training program. Evaluated by James Whitworth, PhD, LCSW

15322 Aviation Loop Dr Brooksville, FL 34604 Mary Peter, CEO

Organization/Site (3) K9 Partners for Warriors

Provides service canines to warriors suffering from PTSD, TBI Traumatic Brain Injury, and/or MST.

114 Camp K9 Road Ponte Vedra Beach, FL 32801 Patty Dodson

Organization/Site (4)Guardian Angels Medical Service Dogs, Inc.

Rescues, raises, trains and then donates individually trained medical service dogs to veterans and others struggling with a myriad of disabilities.

3251 NE 180 Ave. Williston, FL 32696

Music Therapy            

Organization/Site (1) Tampa Bay Institute for Music Therapy

Works to provide Music Therapy to individuals experiencing TBI & psychological trauma, including PTSD.

311 E Bullard Pkwy, Suite A

Temple Terrace, FL 33617 Sharon Graham, Exc.

Director

Organization/Site (2) Creative Forces: NEA Military Healing Arts

Provides art, music, and dance therapies, for military patients and veterans with TBI & psychological trauma.

400 7th Street, SW Washington, DC 20506 Mary Anne Carter,

Chairman

           

Page 23 of 36

Hyperbaric Oxygen Therapy

Organization/Site (1) National Hyperbaric Treatment Center

Provides HBOT for numerous medical conditions, including PTSD and TBI.

31608 US Highway 19 North

Palm Harbor, FL 34684 Dr. Allan Spiegel

Organization/Site (2) Oxygen Rescue Care Centers of America

Specializes in the use of HBOT for "off-label" conditions in addition to TBI, PTSD, etc.

525 NE 3rd Ave, Suite 107

Delray Beach, FL 33444 Ray H. Cralle, RRT

Organization/Site (3) Tallahassee Memorial Healthcare

Provides HBOT for PTSD and TBI.

1300 Miccosukee Road Tallahassee, FL 32308 Dean Watson

Page 24 of 36

Initial results for the 3 organizations that have contributed data to the project to date are

summarized in the pages that follow. This includes initial results for the modalities Accelerated

Resolution Therapy (ART), Equine Therapy, and Service Animal Assisted Therapy.

Accelerated Resolution Therapy (ART)

To date, 16 veterans have provided data for enrollment of services with Accelerated

Resolution Therapy (ART). All 16 of these veterans were enrolled at the Veterans Alternative

site in Tampa. Of these 16 veterans, 5 have both pre-assessment and post-assessment data.

As seen in Table 1a, most veteran participants were of non-Hispanic white race with

primary service in the Army. Previous trauma history was significant, with 69% witnessing death

or execution and 44% being exposed to an IED blast or combat explosion. The prevalence of

possible TBI/concussion-related symptoms was high, especially for headaches (56%), memory

problems (69%), ringing in ears (69%), and sleep problems (69%). Medication use for pain,

depression, anxiety, and sleep problems was also common.

Table 1a. Presenting Characteristics of Veterans Enrolled (Accelerated Resolution Therapy - ART) (n=16)

Characteristic PrevalenceProgram (n, %) Accelerated Resolution Therapy 15 (93.7) Accelerated Resolution Therapy + Equine Therapy 1 (6.3)Age in years (n, %) 18 to 29 2 (12.5) 30 to 39 7 (43.7) 40 to 49 1 (6.2) 50 to 59 4 (25.0) 60 to 69 2 (12.5)Female gender (n, %) 2 (12.5)Race (n, %) White 10 (62.5) Black/African American 5 (31.2) Native Hawaiian/Pacific Islander 1 (6.2)Hispanic Ethnicity (n, %) 1 (6.2)Primary military service (n, %) Army 12 (75.0) Marine Corps 2 (12.5) Marine Corps Reserves 1 (6.2) Air Force 1 (6.2)Number of deployments (n, %) None 6 (37.5)

Page 25 of 36

One 6 (37.5) Two 2 (12.5) Three 1 (6.2) Four or more 1 (6.2)Previous trauma history Witness death or execution (n, %) 11 (68.7) IED blast or combat explosion (n, %) 7 (43.7) Witness major injuries (non-lethal) (n, %) 10 (62.5) Physical assault (n, %) 5 (31.2) Sexual assault (n, %) 5 (31.2)Current possible TBI/concussion-related symptoms Headaches (n, %) 9 (56.2) Dizziness (n, %) 6 (37.5) Memory problems (n, %) 11 (68.7) Balance problems (n, %) 7 (43.7) Ringing in ears (n, %) 11 (68.7) Irritability (n, %) 8 (50.0) Sleep problems (n, %) 11 (68.7)Current medications Pain (n, %) 7 (43.7) Depression (n, %) 9 (56.2) Anxiety (n, %) 8 (50.0) Seizures (n, %) 1 (6.2) Sleep (n, %) 8 (50.0)

Table 2a provides results for symptoms of PTSD, depression, anxiety, and somatization at the

start and end of the ART program (typically 1 to 2-week time period). As seen, PTSD scores

from the 20-item PCL-5 instrument dropped from a mean of 44.6 to 18.4 after completion of the

ART program. This represents a 59% reduction in self-reported symptoms of PTSD (see figure

2a as well). In addition, by use of these established cutpoint score of >33 on the 20-item PCL-5

(PTSD) checklist as probable diagnosis of PTSD, 80% of veterans met this criteria at the start of

the program compared to 0% at the end of the program.

Page 26 of 36

Table 2a - ATOV Program Evaluation ReportComparison of Pre and Post Retreat Symptoms

Accelerated Resolution Therapy (ART) Programs

Characteristic Total (N=10)

a. Pre-program

assessment(N=5)

b. Post-program

assessment(N=5)

p-value

PCL5 (PTSD) score (total), mean, SD 31.5, 20.6 44.6, 19.4 18.4, 12.3 0.07

PCL5 Intrusion subscale score, mean, SD 6.7, 5.8 10.6, 5.8 2.8, 2.2 0.06

PCL5 Avoidance subscale score, mean, SD 2.9, 2.2 4.2, 2.3 1.6, 1.1 0.13

PCL5 Mood-Cognition subscale score, mean, SD 13.5, 7.6 18.2, 5.4 8.8, 6.8 0.06

PCL5 Arousal subscale score, mean, SD 8.4, 6.2 11.6, 7.1 5.2, 3.2 0.13

Provisional PTSD diagnosis based on PCL-5, % 30.0 60.0 0.0 ---

PTSD cutpoint diagnosis (PLC5 score >=33), % 40.0 80.0 0.0 ---

Brief Symptom Inventory (BSI) score (total), mean, SD

21.2, 12.6 27.6, 11.5 14.8, 11.0 0.03

BSI Somatization subscale score, mean, SD 5.7, 4.3 7.6, 4.0 3.8, 4.1 0.005

BSI Depression subscale score, mean, SD 7.6, 4.6 10.0, 3.5 5.2, 4.4 0.04

BSI Anxiety subscale score, mean, SD 7.9, 5.2 10.0, 6.0 5.8, 3.7 0.18

Figure 2a. PTSD (PCL-5) scores for veterans treated with ART before (pre-program) and after (post-program) receipt of services.

Page 27 of 36

The de-identified listing of veterans who received services with ART follows:

Veterans Served with ART: November 1 – December 31, 2019

01F79

01K66

01M06

01M86

01R47

02K29

02K68

05D05

06C88

07F41

07M31

09B95

09S72

10M19

11W22

12P47

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Equine Therapy

To date, 7 veterans have provided data for enrollment of services with Equine Therapy.

All 7 of these veterans were enrolled at Quantum Leap Farm in Odessa, FL. All 7 of these

veterans provided pre-assessment and post-assessment data.

As seen in Table 1b, most veteran participants were age 40 to 49 years, all were female,

and with equal representation of service (42.9%) in the Army and Navy. In terms of trauma

history, the prevalence of physical assault (57%) and sexual assault (86%) was high. The

prevalence of possible TBI/concussion-related symptoms was also high, especially for memory

problems (71%), ringing in ears (71%), irritability (71%), and sleep problems (71%). Medication

use for pain, depression, anxiety, and sleep problems was also common (71% for all).

Table 1b. Presenting Characteristics of Veterans Enrolled (Equine Therapy) (n=7)

Characteristic PrevalenceProgram (n, %) Equine Therapy 5 (71.4) Equine Therapy + Accelerated Resolution Therapy 2 (28.6)Age in years (n, %) 40 to 49 4 (57.1) 50 to 59 2 (28.6) 60 to 69 1 (14.3)Female gender (n, %) 7 (100.0)Race (n, %) White 4 (57.1) Black/African American 3 (42.9)Hispanic Ethnicity (n, %) 1 (14.3)Primary military service (n, %) Army 3 (42.9) Navy 3 (42.9) Marine Corps 1 (14.3)Number of deployments (n, %) None 2 (28.6) Two 2 (28.6) Three 2 (28.6) Four or more 1 (14.3)Previous trauma history Witness death or execution (n, %) 2 (28.6) IED blast or combat explosion (n, %) 1 (14.3) Witness major injuries (non-lethal) (n, %) 2 (28.6) Physical assault (n, %) 4 (57.1) Sexual assault (n, %) 6 (85.7)Current possible TBI/concussion-related symptoms Headaches (n, %) 4 (57.1)

Page 29 of 36

Dizziness (n, %) 3 (42.9) Memory problems (n, %) 5 (71.4) Balance problems (n, %) 3 (42.9) Ringing in ears (n, %) 5 (71.4) Irritability (n, %) 5 (71.4) Sleep problems (n, %) 5 (71.4)Current medications Pain (n, %) 5 (71.4) Depression (n, %) 5 (71.4) Anxiety (n, %) 5 (71.4) Seizures (n, %) 0 (0.0) Sleep (n, %) 5 (71.4)

Table 2b provides results for symptoms of PTSD, depression, anxiety, and somatization at the

start and end of the Equine Therapy program. As seen, PTSD scores from the 20-item PCL-5

instrument dropped from a mean of 50.0 to 28.0 after completion of the Equine Therapy

program. This represents a 44% reduction in self-reported symptoms of PTSD (see figure 2b). In

addition, by use of these established cutpoint score of >33 on the 20-item PCL-5 (PTSD)

checklist as probable diagnosis of PTSD, 86% of veterans met this criteria at the start of the

program compared to 29% at the end of the program.

Table 2b - ATOV Program Evaluation ReportComparison of Pre and Post Retreat Symptoms

Equine Therapy Programs

Characteristic Total (N=14)

a. Pre-program

assessment(N=7)

b. Post-program

assessment(N=7)

p-value

PCL5 (PTSD) score (total), mean, SD 39.0, 20.1 50.0, 12.4 28.0, 21.0 0.02

PCL5 Intrusion subscale score, mean, SD 7.7, 5.1 10.0, 4.4 5.4, 5.1 0.03

PCL5 Avoidance subscale score, mean, SD 4.7, 2.6 6.0, 2.1 3.4, 2.6 0.02

PCL5 Mood-Cognition subscale score, mn, SD 14.4, 7.7 18.4, 4.9 10.3, 8.1 0.01

PCL5 Arousal subscale score, mean, SD 12.2, 6.4 15.6, 4.2 8.9, 6.6 0.04

Provisional PTSD diagnosis based on PCL-5, % 57.1 85.7 28.6 0.046

PTSD cutpoint diagnosis (PLC5 score >=33), % 57.1 85.7 28.6 0.046

Brief Symptom Inventory (BSI) score (total), mean, SD

28.1, 16.3 40.7, 6.3 15.6, 13.0 0.001

BSI Somatization subscale score, mean, SD 8.9, 5.0 12.9, 2.4 4.9, 3.4 0.003

Page 30 of 36

Characteristic Total (N=14)

a. Pre-program

assessment(N=7)

b. Post-program

assessment(N=7)

p-value

BSI Depression subscale score, mean, SD 10.1, 7.0 14.3, 4.3 6.0, 7.0 0.005

BSI Anxiety subscale score, mean, SD 9.1, 5.8 13.6, 3.6 4.7, 3.8 0.002

Figure 2b. PTSD (PCL-5) scores for veterans treated with Equine Therapy before (pre-program) and after (post-program) receipt of services.

De-identified listing of veterans who received services with Equine Therapy is provided below:

Veterans Served with Equine Therapy -- November 1 – December 31, 2019

08W64

05C46

08F72

11M18

09H41

04W65

06H59

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Service Animal Assisted Therapy

To date, 6 veterans have provided data for enrollment of services with Service Animal

Assisted Therapy (i.e. service dog). Of these 6 veterans, one completion both the pre-approval

application phase and then was approved for receipt of a service dog (hence 2 assessments). In

future analyses, results will be presented by each phase of the approval process for a service dog.

All of the veterans were enrolled at Guardian Angels Medical Service Dogs, Inc. in Williston,

FL. Given the early stage of the process, only pre-assessment data is available for the current

report.

As seen in Table 1c, most veteran participants were age 30 to 39 years, only one was

female, and nearly all (85.7%) were of White race. In terms of trauma history, most (71.4%) had

witnessed death or execution, 43% had experienced IED blast or combat explosion, and 86% had

witnessed non-lethal major injuries. The prevalence of possible TBI/concussion-related symptoms

was very high, especially for headaches, irritability, and sleep problems (all 86%).

Table 1c. Presenting Characteristics of Veterans Enrolled (Service Animal Therapy) (n=7)

Characteristic PrevalenceProgram (n, %) Service Animal (Dog) Therapy 5 (71.4) Service Animal (Dog) Therapy + Hyperbaric Oxygen Therapy 1 (14.3) Service Animal (Dog) Therapy + Music Therapy 1 (14.3)Current status of placement with service dog (n, %) In the pre-approval application phase 6 (85.7) Approved for receipt of a service dog 1 (14.3)Age in years (n, %) 18 to 29 1 (14.3)) 30 to 39 3 (42.9) 40 to 49 2 (28.6) 60 to 69 1 (14.3)Female gender (n, %) 1 (14.3)Race (n, %) White 6 (85.7) Black/African American 3 (14.3)Hispanic Ethnicity (n, %) 0 (0.0)Primary military service (n, %) Army 4 (57.1) Navy 1 (14.3) Air Force 2 (28.6)Number of deployments (n, %) None 3 (42.9) One 3 (42.9)

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Four or more 1 (14.3)Previous trauma history Witness death or execution (n, %) 5 (71.4) IED blast or combat explosion (n, %) 3 (42.9) Witness major injuries (non-lethal) (n, %) 6 (85.7) Physical assault (n, %) 3 (42.9) Sexual assault (n, %) 1 (14.3)Current possible TBI/concussion-related symptoms Headaches (n, %) 6 (85.7) Dizziness (n, %) 4 (57.1) Memory problems (n, %) 5 (71.4) Balance problems (n, %) 4 (57.1) Ringing in ears (n, %) 5 (71.4) Irritability (n, %) 6 (85.7) Sleep problems (n, %) 6 (85.7)Current medications Pain (n, %) 3 (42.9) Depression (n, %) 3 (42.9) Anxiety (n, %) 4 (57.1) Seizures (n, %) 0 (0.0) Sleep (n, %) 2 (28.6)

The de-identified listing of veterans who began to receive services with Service Animal Assisted

Therapy (service dogs) is provided below:

Veterans Served with Initial Service Dog Services: November 1 – December 31, 2019

02V84 Pre-approval phase and Approval phase

03M56 Pre-approval phase

05M02 Pre-approval phase

09M06 Pre-approval phase

11X11 Pre-approval phase

12W31 Pre-approval phase

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2.4 Estimated Return on Investment (ROI)

For the 5 veterans who received services with ART and 7 veterans who received services

with Equine Therapy, and who provided pre-program and post-program assessment data, initial

estimates of return on investment (ROI) can be calculated.

According to the Congressional Budget Office (CBO) report (February 2012) entitled “The

Veterans Health Administration’s Treatment of PTSD and Traumatic Brain Injury Among

Recent Combat Veterans”( http://www.cbo.gov/sites/default/files/cbofiles/attachments/02-09-

PTSD.pdf), average annual health care costs of veterans treated within the Veterans Health

Administration (VHA) are $8,300 for veterans with post-traumatic stress disorder (PTSD),

versus $2,400 in the absence of PTSD. Of note, annual treatment costs are higher in the presence

of comorbidities associated with PTSD which are common and may include traumatic brain

injury (mTBI). Moreover, it should not be assumed that all annual healthcare costs for a given

veteran are represented within the VHA system. Nonetheless, these data are used to formulate

conservative estimates of return on investment (ROI) associated with the different alternative

treatment options for veterans being evaluated.

From the above, the net difference in annual health care costs in the presence versus absence

of PTSD are $8,300 - $2,400 = $5,900 per veteran.

In the Alternative Treatment Options for Veterans (ATOV) program evaluation, not all

veterans who receive services are required to present with a high level of PTSD or TBI

symptomatology. However, the inclusion criteria for the project require that all veterans have a

prior history of service-connected diagnosis of PTSD and/or TBI, and that all had previously

sought treatment. Therefore, it is expected that the majority of veterans served and evaluated in

the ATOV program will generally present with high levels of PTSD and/or TBI

symptomatology.

ROI – Accelerated Resolution Therapy (ART)

The estimate of ROI for veterans provided services with ART is based on veterans with pre-

and post-program data. For these 5 veterans served with complete data, mean pre- and post-

retreat scores on the 20-item PCL-5, a validated measure of PTSD symptom severity, were 44.6

and 18.4, respectively. This represents a 58.7% reduction in PTSD symptom level severity

associated with the services provided. Applying this symptom reduction level to the net annual

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treatment costs associated with PTSD within the VHA system equates to an estimated annual

savings of $3,463 per veteran (i.e. $5,900 x 0.587).

The benefits received from treatment with ART are believed to have sustained health benefits

well beyond the period in which services were provided. Therefore, to be conservative, we

estimate total ROI based on 10 years of benefits obtained from receipt of services, recognizing

that many veterans may experience benefits long beyond 10 years.

Therefore, the estimated ROI for each veteran who received services through an ART

program is:

$3,463 x 10 years = $34,630 per veteran.

With 5 veterans served and with complete pre- and post-assessment data, 10-year cumulative

savings are estimated at:

$34,630 x 5 veterans = $173,150 total savings.

Again, the above estimates do not consider alternative sources of cost benefits realized,

such as those among family members associated with veterans served, reductions in interactions

with the criminal justice system, and many other societal benefits.

ROI – Equine Therapy

The estimate of ROI for veterans provided services with Equine Therapy is based on veterans

with pre- and post-program data. For these 7 veterans served with complete data, mean pre- and

post-retreat scores on the 20-item PCL-5, a validated measure of PTSD symptom severity, were

50.0 and 28.0, respectively. This represents a 44.0% reduction in PTSD symptom level severity

associated with the services provided. Applying this symptom reduction level to the net annual

treatment costs associated with PTSD within the VHA system equates to an estimated annual

savings of $2,596 per veteran (i.e. $5,900 x 0.44).

The benefits received from treatment with Equine Therapy are believed to have sustained

health benefits well beyond the period in which services were provided. Therefore, to be

conservative, we estimate total ROI based on 10 years of benefits obtained from receipt of

services, recognizing that many veterans may experience benefits long beyond 10 years.

Therefore, the estimated ROI for each veteran who received services through an Equine

Therapy program is:

$2,596 x 10 years = $25,960 per veteran.

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With 7 veterans served and with complete pre- and post-assessment data, 10-year cumulative

savings are estimated at:

$25,960 x 7 veterans = $181,720 total savings.

Again, the above estimates do not consider alternative sources of cost benefits realized,

such as those among family members associated with veterans served, reductions in interactions

with the criminal justice system, and many other societal benefits.

ROI – Service Animal Assisted Therapy

An estimate of ROI for veterans provided services with Service Animal Assisted Therapy

(service dog) cannot be made at this time as no data are available for veterans after receipt of a

service dog.

ROI – Music Therapy

An estimate of ROI for veterans provided services with Music Therapy cannot be made at this

time as no data are available before and after receipt of services.

ROI – Hyperbaric Oxygen Therapy (HBOT)

An estimate of ROI for veterans provided services with Hyperbaric Oxygen Therapy (HBOT)

cannot be made at this time as no data are available before and after receipt of services.

Summary of ROI

From initial available data, the total estimated ROI for veteran who received services

through the Alternative Treatment Options for Veterans participating organizations is as follows:

Accelerated Resolution Therapy: $173,150

Equine Therapy: $181,720

Total Estimated Savings: $354,870

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