Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Sponsor: University of Massachusetts, Worcester

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1. TITLE 
Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans with PTSD  
 
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
3. PRIOR APPROVALS: 
 
 
Conflict of Interest (COI): N/A  
 
Clinical Engineering Department: N/A 
 
Biohazardous Agents: 
According to the guidelines “ An IBC registration is NOT required if: • The protocol ONLY 
involves sending human samples to the UMMHC clinical laboratories.”  
 
Radiation: 
N/A 
 
4. OBJECTIVES* 
The purpose of this study is to examine the influence of Animal Assisted Intervention wildlife 
activities on veterans with PTSD. The specific aims of this study are to explore a series of 
wildlife animal-assisted interventions with 50 veterans who have PTSD/ PTSD symptoms in 
order to: 
1. Determine the feasibility, safety and acceptability of the interventions to ensure adequacy of 
each intervention for a larger RCT. Outcomes will be measured by recruitment and retention, 
rate of adverse events, activity surveys and focus groups. 
2. Obtain preliminary estimates of the wildlife AAI on physiologic and psychological well-
being and assess relative efficacy of the three interventions. Outcomes will be measured by 
the PCL-5,23, 24 Warwick-Edinburgh Mental-Well Being Scale,44, 45 Speilberger State/Trait 
Anxiety Inventory46 and Center for Epidemiologic Studies Depression (CES-D-10) scale.47 
Physiologic measures include heart rate variability. 49 
3. Obtain preliminary estimates of connectedness to nature and wildlife through the short-form 
Nature-Relatedness (NR-6)50 and Human-Wildlife Bridging Feelings of Valuation Scale.20    
 
5. BACKGROUND* 
Introduction 
Human-animal interactions within a variety of settings and populations have shown positive 
health benefits.1 While the field of human-animal interaction is very promising there is need for a 
more rigorous evidence base.2,3 Research on human-animal interactions has primarily been done 
with domesticated animals such as pets. We propose a novel approach using a series of wildlife 
activities for veterans suffering from PTSD following their military duty. The activities will be 

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conducted primarily within settings of wildlife rehabilitation and sanctuary. Our belief is that 
placing veterans in a healing environment where they can connect with animals that have also 
suffered loss and trauma may foster healing in the veterans themselves. 
Significance: Human-Animal Interaction and Post-Traumatic Stress Disorder in Military 
Veterans 
Animal-assisted intervention (AAI) has been defined as, "any intervention that intentionally 
includes or incorporates animals as part of a therapeutic or ameliorative process or milieu."4, p.36 
AAI includes the use of animals within specific therapeutic interventions (Animal-Assisted 
Therapy), less structured activities with animals (Animal-Assisted Activities) and use of trained 
animals to assist with daily activities (Service/Assistance Animals)2 A meta-analysis of 49 
studies using animal-assisted therapy found improved outcomes in four areas with moderate 
effect sizes: medical conditions, autism-spectrum symptoms, behavioral problems, and emotional 
well-being.1  
One of the populations for which evidence supports possible AAI benefits is persons with 
post-traumatic stress disorder (PTSD). PTSD is a psychiatric disorder that can occur in people 
who have experienced or witnessed a traumatic event such as a serious accident, rape or other 
violent personal assault or war/ combat.5 PTSD can affect anyone but has been particularly 
concerning among veterans suffering from wartime trauma. The prevalence of PTSD in veterans 
who served in recent wars in Iraq and Afghanistan ranges from 13.5-30% with an estimated 
500,000 U.S. troops diagnosed with PTSD.6 Symptoms of PTSD include intrusive thoughts or 
flashbacks to the traumatic event, avoiding reminders of the event such as people or places, 
negative thoughts or feelings, and arousal/ reactive symptoms such as irritable outbursts and self-
destructive behavior.5 PTSD is potentially a very debilitating condition that is associated with a 
higher risk of suicidal behavior, particularly among young, female and rural veterans. In addition 
to suicide, struggles with substance abuse and homelessness are significant problems for the 
population of veterans with PTSD.6 Stigma is a major barrier to receiving treatment for PTSD; 
studies suggest that less than half of veterans with PTSD seek treatment within the first year.7 
Animal-assisted interventions have been utilized as complementary approaches that may 
alleviate this barrier due to “the nonjudgmental nature of human-animal interactions.”7 
A systematic review conducted in 2015 found 10 studies on the use of AAI in trauma using 
dogs, horses and/ or farm animals.  Only two of these focused on war trauma. The studies 
suggested that AAI was a promising complementary therapy, particularly in reducing PTSD 
symptoms, depression and anxiety, but that more rigorous studies are needed.2 A review on the 
use of service dogs in veterans with PTSD found that although canine assistance was an 
encouraging complementary modality there was a need to determine best practices as well as 
challenges with service dog availability and cost.6 In sum, HAI offers a promising approach for 
individuals suffering from war trauma but additional research is needed.6,8,9 Given the practical 
challenges obtaining trained service dogs, it will be important to study modalities with other 
animals.   
Scientific Premise: Wildlife and Health 
The contemporary human disconnect from nature is an increasing health concern.10,11 A growing 
body of literature supports favorable physiological, psychological and social health benefits from 
nature contact10,11,12,13 Although there is promising literature on the benefits of both nature and 
animals, few studies have explored human interactions with animals that inhabit natural settings, 
or wildlife. The majority of HAI studies have focused on domesticated animals. Yet there are 

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promising accounts of human-wildlife interactions. Brock et al. distinguish between everyday 
and iconic wildlife.14 Iconic wildlife experiences have been studied with individuals on wildlife 
tours with reported enhanced well-being and psychological benefits.15 Everyday wildlife encounters 
such as home bird feeding may have human benefit.12  
One important example of everyday wildlife interaction is bird feeding/ watching. Bird 
feeding has been linked with positive psychological benefits through feelings of pleasure and 
increased connectedness to nature. Self-reported well-being was associated with increased 
species diversity at feeder and familiarity with different species.12 A neighborhood modeling 
study in the United Kingdom linked afternoon bird abundance (time of day when people were 
more likely to be outdoors experiencing birds) with reduced self-reported depression, anxiety 
and stress.16  Brock et al. found that individuals who fed birds developed a “warden attitude” of 
concern for the birds that visited their own feeder.14 A survey of 1291 bird-feeding hobbyists 
found that among the reasons for feeding birds were bringing nature and beauty to one’s area 
(84%); wanting to help birds (79%) and relaxation or therapy (65%)17 A bird feeder intervention 
with nursing home residents was found to increase perceptions of happiness, being active and 
having control over life.18 Interestingly, the first formal maximum-security prisoner-canine 
program developed when staff noted the positive benefits experienced by prisoners that found 
and cared for an injured bird.19 Thus, studies suggest that both wildlife viewing and providing 
wildlife care have therapeutic value.    
Preliminary Data 
Our study of visitors to a wildlife sanctuary demonstrated significantly increased emotional 
connection to both predator and nonpredator species.20 Connectedness with wildlife is important 
because connection to nature is linked with higher perceived happiness.12, 21 Specifically, 
findings suggested that participants had a significantly stronger emotional connection to moose 
as compared to coyote at baseline but that both moose and coyote scores increased significantly 
from pre to post visit. The study also tested a new instrument developed by the PI to measure 
emotional connection to animals which demonstrated good internal validity (Cronbach’s 
alpha=.837-.940). 20 Increased emotional connection toward both valued and dis-valued 
species suggests that wildlife encounters may increase appreciation for diverse species which 
is important for balanced ecosystems.20 Additionally, the findings suggest that learning about 
wildlife at the sanctuary reinforced and expanded attitudes and planned behaviors toward 
spending more time outdoors as well as environmental/ wildlife stewardship for both 
children and adults.20 Thus, in addition to individual benefits, experiences with wildlife may 
hold broader potential for improving human health through fostering positive attitudes 
toward wildlife and habitat conservation. 
Theory-Guided Intervention: Wildlife Immersion Activities  
The study will be guided by the PI’s theory of transcendent pluralism which is grounded in 
mutually evolving human and ecological dignity.20, 31, 32 Wildlife experiences are viewed as 
pluralistic encounters that influence wonder and transcendence. In many Native American 
traditions each species of animal is viewed as having its own qualities that offer teachings for 
humans.33, 34 Thus a variety of species may meet different human needs. 
The activities that comprise the interventions will be framed within the concept, “Embodied 
spatial-temporal interaction”, which emerged from the PIs prior study on wildlife 
rehabilitation.35 Spatial territory is a core need for animals and must be respected when 
conducting AAI to avoid animal stress. Engagement in shared wildlife space requires 

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attentiveness to one’s own spatial relationship to the animal. Safe space is also important for 
humans. There is a permeable boundary between humans and wildlife.36 Wildlife rehabilitation 
and sanctuary care offer a healing window across this boundary. Study activities will be guided 
by experts so that the appropriate boundaries in each setting are maintained. Activities will also 
be framed within the natural rhythms of the seasons to be in synchronicity with animal needs. 
For example, spring is when baby wildlife may be orphaned and require human care. Thus, each 
intervention for this study is designed as an immersion activity experience within the space of a 
wildlife setting rather than a discrete action. The experience occurs in a wildlife-rich space and 
may include multiple interactions with diverse animal species over a period of time. We define a 
wildlife immersion activity as an embodied spatial-temporal experience in which human 
participants enter a space (setting) in which they consciously engage with wildlife in a 
manner that affirms the dignity of both human and animal with respect for natural 
rhythms. Wildlife immersion experiences are designated as animal-assisted activities (in 
contrast to animal-assisted therapy which entails formal therapeutic treatment).2  
 
6. INCLUSION AND EXCLUSION CRITERIA* 
Inclusion criteria:  
• Veterans with PTSD/PTSD symptoms (per self report) 
• Vaccination status for Covid-19 as: 
o Fully vaccinated against Covid-19 and up to date with booster, which is defined 
by the CDC (as of May 6, 2022) as: 
▪ Initial vaccination: 
• 2 weeks after second dose in a 2-dose series, such as the Pfizer or 
Moderna vaccines, or 
• 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s 
Janssen vaccine 
▪ PLUS: one booster, when eligible 
OR 
o Partially vaccinated against Covid-19 and willing/able to (a) complete a home 
antigen test for Covid-19 on the morning of each activity and report results to the 
PI prior to transportation departure and (b) willing to wear a mask during 
transportation to and from the activity  
• Age 18-70 
• Comfortable interacting with animals 
• Sufficient mobility to walk or navigate wheelchair up to one mile at leisurely pace 
• Cognitive ability to complete assessments  
• Service/ support animals are permitted as long as they meet the following criteria: the 
animal must be leashed, housebroken and with sufficient training that the owner has 
control over its barking and any other behaviors that would threaten the safety of other 
visitors or animals. 
• Participants with visual or hearing impairments must have corrected vision and hearing 
through glasses and/ or hearing aid(s). 
• No active addiction or intoxication as determined by 30 days or more free from drugs or 
alcohol abuse  

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• Willing to refrain from alcohol and illicit substances before and during activities  
• No severe immunosuppression or other conditions with advisement by health care 
provider to limit or prevent contact with animals and birds  
• No severe outdoor allergy. Not currently enrolled in the Veteran’s Treatment Court 
program 
 
Exclusion criteria: 
• Veterans without PTSD/PTSD symptoms (per self report) 
• Not fully vaccinated and up to date against Covid-19  
OR 
o Partially vaccinated against Covid-19 and not willing to (a) complete a home 
antigen test for Covid-19 on the morning of each activity and report results to the 
PI prior to transportation departure and (b) willing to wear a mask during 
transportation to and from the activity  
• Age <18 or >70 
• Not comfortable interacting with animals 
• Not sufficiently mobile to walk or navigate wheelchair up to one mile at leisurely pace 
• Cognitively unable to complete assessments  
• Service/ support animals that do not meet the following criteria: leashed, housebroken 
and with sufficient training that the owner has control over its barking and any other 
behaviors that would threaten the safety of other visitors or animals. 
• Participants with visual or hearing impairments who do not have corrected vision and 
hearing through glasses and/ or hearing aid(s). 
• Active addiction or intoxication as determined by < 30 days free from drugs or alcohol 
abuse  
• Not willing to refrain from alcohol and illicit substances before and during activities 
• Severe immunosuppression or other conditions with advisement by health care provider 
to limit or prevent contact with animals and birds  
• Severe outdoor allergy 
• Currently enrolled in the Veteran’s Treatment Court program 
 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A 
 
9. STUDY TIMELINES* 
The study timeline is outlined in the table below.  We anticipate enrolling 30 participants in year 
1 of the study and 20 participants in year 2 of the study.  Each participant will be in the study for 
6-8 months from enrollment to final data collection. The timing of activity schedule may be 
modified slightly based on feedback of study advisory committee to be convened.   
 

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Study Timeline (2 year) 
 *Note: we are now in no-cost extension until Dec. 2022 due to Covid delays 
Updated Dec. 18, 2018 
 
 
Setting 
Year 1 (N=30 of 50) 
Year 2 (N=20 of 50) 
Mar 
Apr- 
June 
July- 
Aug 
Sept- 
Oct 
Nov- 
Dec 
Jan-
Feb  
Mar 
Apr- 
June 
July- 
Aug 
Sept- 
Oct 
Nov- 
Dec 
Jan-
Feb  
IRB Initial 
Approval 
 
X    
-in 
proce
ss  
 
 
 
 
 
 
 
 
 
 
 
 
IRB Renewal 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Hire & train 
research staff 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
Convene Advisory 
Committee 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
Recruitment 
 
X 
X 
25% 
X 
50% 
 
 
 
X 
X 
75% 
X 
100
% 
 
 
 
Introductory  
Forest walk 
Time 1/Time 2  
Harvard 
Forest 
 
X 
 
 
 
 
 
X 
 
 
 
 
Wildlife Activity I  
Wildlife rehab 
Time 1/Time 2 
NEWC 
 
X 
 
 
 
 
 
X 
 
 
 
 
Wildlife Activity II 
Wildlife observation  
Time 1/Time 2 
MWP 
 
 
X 
 
 
 
 
 
X 
 
 
 
Wildlife Activity III 
Bird feeding 
Time 1/Time 2 
Mass  
Aud. & 
Soldier 
On 
 
 
 
X 
X* 
 
 
 
 
X 
X* 
 
F/U interview/ 
phone survey 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
Data Analysis 
 
 
 
 
 
X 
X 
 
 
 
 
 
X 
X 
*Participants will have option to continue bird feeding after study completed 
 
 
 
10. STUDY ENDPOINTS* 
• The primary outcome measures are from study Aim I: Feasibility and safety of 
intervention will be measured through ongoing observation and safety logs and 
monitoring of recruitment/ retention.  Acceptability will be assessed with activity 
evaluation surveys, focus groups at study conclusion and a follow-up personal interview/ 
phone call  to assess bird feeder use.  
 
• The secondary outcome measures are from Aim II and Aim III: Psychological well-being 
will be assessed at baseline and after each activity through: Warwick-Edinburgh Mental-
Well Being Scale (14 item; α=.91)44, 45, Speilberger State/Trait Anxiety Inventory (6 
item; α=.82)46 and Center for Epidemiologic Studies Depression (CES-D-10) scale (10 
item; α=.70).47 We will measure physiological parameters (heart rate via wearable wrist 
biosensor)48 at baseline with F/U heart rate both before and after each activity. We will 

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also obtain the PCL-5 at baseline and a follow up measure of the PCL-5, at study 
conclusion.23, 24 Connection to nature and wildlife will be measured at baseline and after 
each activity through: the short-form Nature-Relatedness (NR-6) (6 item; α=.85-.96)50 
and Transcendent Feelings of Animal Valuation  Scale developed by PI (7 item; α=84-
.94).20   Qualitative assessment will include an animal observation  journal exercise 
during the Maine Wildlife Park activities.  
.  
 
There are no safety endpoints. 
11. PROCEDURES INVOLVED* 
Approach 
The feasibility nature of this study offers flexibility to evaluate a series of immersion activities. 
We will use a crossover design in which each participant receives a sequence of 3 wildlife-
immersion activities and serves as his or her own control.37 The use of crossover designs has 
been suggested for future AAI studies.3 The intervention will include an introductory forest walk 
followed by 3 wildlife immersion activity experiences in different settings that offer different 
ways to experience wildlife. All activities will be guided by field experts and include education 
to ensure safety for human subjects as well as animals. Wildlife education programs have been 
shown to reduce fear and enhance self efficacy about managing encounters with wildlife.38, 39 
Each activity will be conducted twice to minimize potential anxiety and novelty effects. 
Activities will be planned in small groups (up to 10 participants) to provide more concentrated 
experience at facilities and peer support. We will endeavor to maintain same groups throughout 
although logistical modification may sometimes be needed. 
Activities (see protocol below for detailed outline) include: Introductory Forest Walk: A 
guided forest walk will be conducted to control for effects of nature alone; Wildlife Immersion 
Activity I: Participants will experience wildlife through a wildlife rehabilitation setting in which 
they engage in activities such as feeding baby animals and enrichment; Wildlife Immersion 
Activity II: Participants will experience wildlife through observation of iconic wildlife at a 
wildlife park/ sanctuary and accompanying game keepers during feeding/enrichment; and 
Wildlife Immersion Activity III: Participants will experience wildlife in the natural setting 
through bird feeding and watching. This activity is designed to transition to a sustainable home 
activity that veterans can continue following study conclusion. After an initial training at Mass 
Audubon we will provide individual bird feeders to participants as well as community bird 
feeders at the indicated Soldier On facilities. Bird identification education and books will be 
provided. All settings also have self-guided educational displays so free time will be included in 
each session to facilitate each participant’s transcendent inquiry as part of the wildlife immersion 
experience. The time between each set of activities will be spaced by at least one week as a 
washout period to reduce any carryover effect.37 We anticipate that the forest walk will show a 
small improvement over baseline measures at enrollment (due to nature effect) and that each 
animal activity will show an additional improvement above the forest walk (nature plus animal).  
 
 
 
 
 

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Intervention Protocol (to be refined with Advisory Committee) 
 
*Physiological = physiological measures (heart rate) 
Instruments= (Warwick-Edinburgh Mental-Well Being Scale, Speilberger State/Trait Anxiety 
Inventory, CES-D-10; NR-6; Human-Wildlife Bridging Feelings of Valuation Scale; and activity 
evaluation survey). 
 
Location 
Education 
Activities 
Animals 
Involved 
Pre-Measure* 
Post-Measure* 
Screening 
 
 
 
 
Inclusion 
Criteria 
 
 
 
 
 
 
30-45 minutes 
 
 Baseline 
 
 
 
 
-PCL-5 
-Consent 
-Demographics 
-Physio 
-  
-Instruments 
 
Time 
estimate 
 
 
 
 
1 hour 
 
Introductory 
Forest walk  
 
 
 
 
 
 
Time 1 Harvard 
Forest 
Forest 
overview/ 
ecology 
Forest walk  
Non-animal 
intervention 
 
-Heart rate 
-Heart rate 
-Instruments 
Post activity 
survey 
Time estimate  2 hour 
drive each 
way 
30 min. 
1 hour 
Followed by 
lunch 
 
 
5 min. 
 
30 min. 
Time 2 Harvard 
Forest 
Native trees 
Forest walk  
Non-animal 
intervention 
-Heart rate   
-Heart rate 
Instruments 
-Post activity 
survey 
Time estimate 2 hour 
drive each 
way 
30 min. 
 1 hour 
Followed by 
lunch 
 
10 min. 
30 min. 
Wildlife 
immersion 
activity I: 
Wildlife 
rehabilitation 
 
 
 
 
 
 
Time 1 New 
England 
Wildlife 
Center 
-Facility 
overview 
-Wildlife 
rehabilitation 
principles 
-Feeding baby 
animals* 
-Enrichment 
activities 
-Wildlife care 
*expert-
guided 
activities 
integrated 
with routine 
Birds and 
small 
mammals 
such as 
squirrels 
 
 
-Heart rate 
 
-Heart rate 
-Instruments 
-Post activity 
survey 

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care so not to 
cause extra 
animal stress 
Time Estimate 2 and ½ 
hour drive 
each way 
1 hour 
1 ½- 2 hours 
Followed by 
lunch 
 
 
5 min. 
 
30 min. 
Time 2 New 
England 
Wildlife 
Center 
-Human-
wildlife 
interaction 
As above 
Birds and 
small 
mammals 
such as 
squirrels* 
-Heart rate  
-Heart rate 
Instruments  
-Post activity 
survey 
Time Estimate 2 and ½ 
hour drive 
each way 
1 hour 
1 ½-2 hours 
Followed by 
lunch 
 
10 min. 
30 min. 
Wildlife 
immersion 
activity II: 
Wildlife 
Observation 
 
 
 
 
 
 
Time 1 Maine 
Wildlife 
Park 
-Sanctuary 
overview 
-Species info 
-Observation 
-Accompany 
gamekeepers 
during feeding 
 
30 species for 
observation 
(including 
moose, deer, 
bobcats, fox, 
owls, skunks, 
porcupine) 
 
-Heart rate 
 
-Heart rate 
-Animal journal 
-Instruments 
-Post activity 
survey 
Time Estimate 4 hour 
drive each 
way 
1 hour 
2-3 hours 
Followed by 
lunch 
 
. 
5 min.  
 
45 min. 
Time 2 Maine 
Wildlife 
Park 
-Animal 
Enrichment 
-Observation 
-Accompany 
gamekeepers 
during 
enrichment 
-Individual 
animal 
observation 
exercise 
30 species for 
observation 
(as above) 
- 
-Heart rate  
-Heart rate -
Instruments 
-Animal journal 
  (App. G) 
-Post activity 
survey 
Time Estimate 4 hour 
drive each 
way 
1 hour 
2-3 hours 
Followed by 
lunch 
 
10 min. 
45 min. 
Wildlife 
Immersion 
Activity III: 
Bird feeding/ 
watching  
 
 
 
 
 
 
Time 1 Mass 
Audubon 
Broad 
Meadow 
Brook 
-Bird 
identification 
and feeding 
-Nature walk 
with focus on 
identifying 
native bird 
species 
 
-Birds 
 
-Heart rate 
-Heart rate 
-Instruments 
-Post activity 
survey 
 

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Time Estimate 1 ¾ hour 
drive each 
way 
1 hour 
1 hour 
 
 
5 min. 
 
30 min. 
Time 2 At Soldier 
On 
Facilities 
(with 
Mass 
Audubon 
specialist) 
-Bird feeding 
F/U 
-Birds of 
prey 
-Citizen 
scientist  
-Observing 
birds at feeder 
-Observing 
birds of prey 
(with 
specialist) 
-Birds 
-Heart rate 
 
-Heart rate 
-Instruments 
-PCL-5 
-Post activity 
survey 
-Focus group 
(study 
conclusion) 
Time Estimate At Soldier 
On 
1 hour 
1 hour 
 
10 min. 
1- 1 ½  
hours 
Post study Home 
bird 
feeding  
 
 
 
 
-F/U interview/ 
phone call 4-6 
weeks after 
final study 
activity 
Time Estimate  
 
 
 
 
15-20 min. 
  
 
 
 
 
 
Time Estimate 8 weeks total; estimate of 10-15 minutes per day 
  
 
 
 
 
 
*Specific animals will be determined based on facility census and care routine. 
 
 
12. DATA AND SPECIMEN BANKING* 
N/A 
 
13. Data Analysis and Management* 
Instruments described below are provided in the document entitled “Data Collection Forms and 
Surveys” 
 
Scientific Rigor 
Literature on HAI research has identified several methodological issues with recommendations 
to address these including: detailed procedures for future replicability, unbiased outcome 
measures, independent researcher/ intervention teams, provisions for animal welfare and human 
safety3,9 and addressing novelty as a confounder.40 Two additional concerns not appreciated in 
the literature are: (a) need to address nature itself as potential confounder due to health benefits 
from nature contact and (b) sustainability; i.e. many reported studies describe interventions that 
may not be feasible for participants to continue. Table 1 outlines our strategies to address these 
issues. 
 
Table 1. Methodological Strengths 
Issue 
Strategy 
Undocumented procedures 
• Procedure protocol documentation with refinement for future RO1 
study 
Biased evaluation 
• Inclusion of objective measures  

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Researcher/interventionist 
overlap  
• Separate research/ intervention staff 
Animal welfare  
• Wildlife veterinarian consultant 
• Expert-guided activities for best-practices 
• Animal care activities will be integrated with routine care  
• PI with wildlife rehabilitation experience  
Human safety 
• Facilities selected for expertise in educating novices 
• Education and expert-guided activities following all facility protocols 
• Additional measures described in human subjects section 
Novelty as potential confounder 
• Each activity repeated twice 
Nature itself as possible 
confounder 
• Preliminary measures taken after forest walk without animal 
intervention 
Sustainability 
• Settings with native New England habitat and animals 
• Home bird feeding/ watching activity that participants can continue 
• Use of wildlife facilities with public access that participants can visit 
in future.  
 
 
Measures 
We will utilize both quantitative and qualitative measures to assess parameters from study aims 
guided by a unitary-transformative paradigm of integrated bio-psycho-social-spiritual human 
needs.41,42  
Aim I: Feasibility and safety of intervention will be monitored through ongoing observation and 
safety logs and monitoring of recruitment/ retention.  Acceptability will be assessed with 
evaluation surveys after each activity, focus groups at study conclusion and a follow-up phone/ 
in-person interview to assess bird feeder use 4-6 weeks after final study activity. The activity and 
focus group questions will be framed using transcendental method, a cognitive approach 
developed by the PI and used in several prior studies.43  
Aim II: Psychological measures will be conducted at baseline and after each activity to reduce 
learning effects. Psychological well-being will be assessed through Warwick-Edinburgh Mental-
Well Being Scale (14 item; α=.91)44, 45, Speilberger State/Trait Anxiety Inventory (6 item; 
α=.82)46 and Center for Epidemiologic Studies Depression (CES-D-10) scale (10 item; α=.70).47 
We will also measure physiological parameters. Heart rate via wearable wrist biosensor will be 
measured at baseline and before and 5 minutes after each activity. Noninvasive stress markers 
such as heart rate  are preferable as they reduce stress induced by collection and are more 
applicable in the field49 as well as being consistent with a nature-focused intervention. We will 
also obtain a measure of PTSD symptoms through administering the PCL-5 at baseline and  at 
study conclusion.23, 24   
Aim III: Connection to nature and wildlife will be measured with the short-form Nature-
Relatedness (NR-6) (6 item; α=.85-.96)50 and Transcendent Feelings of Animal Valuation Scale 
developed by PI (7 item; α=84-.94)20 at baseline and after each activity.   Qualitative assessment 
will include an animal observation  journal exercise during the Maine Wildlife Park activities.  
 
Data management 

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Surveys with ID numbers will be conducted using pen and paper and collected by PI 
immediately afterwards. Quantitative data will be entered into SPSS version 24 by research 
assistant and/or PI using double data entry. Focus group audiotapes will be transcribed by a 
transcriptionist using Microsoft word files. All data will be stored in a password-protected 
institutional research drive with access limited to investigators and research assistant. Hard 
copies will be kept in locked file/office. 
Analytic Plan  
Sample size and power: Because pilot studies do not provide meaningful estimates of effect 
sizes for between-condition comparisons, due to the imprecision inherent in small samples51,52 
we base our proposed sample size of 50 participants – anticipated average of 10 per group – on 
pragmatics of recruitment, retention, and examination of feasibility, acceptability, and safety, 
providing important information for planning a future R01 study.  Taking retention as an 
illustrative Aim 1 outcome, a 95% confidence interval is (35.5%, 64.5%) for a rate as low as 
50% seen in the PTSD literature,2 and (66.3%, 90.0%) for 80% retention. Dr. Smelson (Co-I) has 
a long standing relationship of working with Soldier On and has obtained follow up rates above 
80% in other studies.53 For Aim 2-3 analyses, we adjust the sample size for possible within-
group correlation (intra-class correlation, ICC) using ICC=0.0105 from a prior study of 
mindfulness.54 Applying the resulting design effect55 of 1+.0105×(10-1)=1.0945 and 80% 
retention rate yields an effective sample size of 40/1.0945=36 participants. With an overall 0.05 
Type I error rate and a Bonferroni correction for multiple testing (6 pairwise comparisons of the 
4 activities), and 80% power, we will be able to detect a statistically significant mean within-
participant between-activity difference in an outcome, e.g., anxiety, of 0.56 SD, where SD 
indicates standard deviation of within-participant change in the outcome. The corresponding 
detectable within-participant change from baseline to end of study or baseline versus each 
individual activity (no corrections for multiple testing), is 0.48 SD.    
Statistical analyses:  
Aim 1: To assess feasibility, we will estimate quantities relevant for study planning, including 
outcome standard deviations and within-participant and within-group correlations, and rates of 
attrition and missing data and their correlates. Acceptability of each activity will be assessed by 
tabulating evaluation surveys responses. Safety for each activity will be assessed via the per-
participant distribution of incidents reported by severity.  Analyses will be conducted for the full 
sample as well as by gender.   
Aim 2: We will conduct preliminary intent-to-treat analyses comparing participant outcomes 
across activities and baseline using linear mixed modeling56 with a random effect for participant 
group and accounting for within-participant correlation over time. In addition, the role of novelty 
for each activity will be estimated as within-participant differences in physiologic outcomes 
between the first and second time that activity is conducted. To the extent possible given sample 
sizes, we will adjust for participant characteristics predictive of missing data to reduce 
nonresponse bias.57 Gender differences will be examined by including gender as a covariate, and 
its interaction with activity to explore effect modification; by necessity, the latter analyses will 
be exploratory.   
Aim 3: Analyses parallel to those in Aim 2 will compare participants’ connectedness to nature 
and wildlife across activities.  Additional exploratory analyses will examine whether 
connectedness to nature and wildlife mediates between-activity differences in well-being in Aim 
2 analyses.   

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Our estimates of retention, intra-group and within-participant correlation, standard deviations, 
and preliminary effect sizes and novelty effects, as well as expert opinion and literature, will 
inform the design of a future larger crossover study, including recruitment and selection of 
activities to be evaluated. This future study will randomize participants to ordering of activities 
(not feasible in this pilot study), permitting formal assessment and analytic treatment of possible 
carryover effects.58 Interestingly, a meta-analysis suggests that effect sizes for AAI do not vary 
greatly by aspects of study design,1 suggesting that estimates from our non-randomized-order 
pilot will be informative for future planning.   
Qualitative analysis:  
Qualitative data will allow us to capture a broader understanding of activity outcomes.  Focus 
groups will be conducted and audiotaped by the PI and transcribed verbatim through a 
transcription service. Open-ended survey questions, F/U phone/ in-person interviews, reflective 
journaling from wildlife park and observation data will be entered into Microsoft word 
documents. Thematic analysis will be conducted by the PI through a rigorous multistage process. 
Raw data will be labeled with codes and analyzed at progressively higher levels of abstraction 
with insight into converging themes.43 Reflexivity and measures of verification recommended by 
Creswell59 will be utilized including prolonged engagement in field, triangulation of data and 
thick, rich description of participant responses.27   
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
The principal investigator (PI) will be responsible for monitoring safety in this study.  The PI 
will accompany study activities and maintain a safety log to report all incidents. Safety will be 
monitored on an ongoing basis.  The safety log will be reported to the Safety Officer (Dr. 
Smelson) on a monthly basis.  An interim analysis report will be conducted after Year I or as 
indicated by regulations. Serious adverse events will be reported to the Safety Officer and IRB 
immediately.  Analysis of any adverse events will be conducted with modification of protocol if 
indicated. Further details are provided in the data and safety monitoring plan document.   
 
Safety Log 
 
 
Date/ 
Time 
No. of 
participants 
in activity 
Safety 
incident 
Etiology 
Intervention 
for 
participant/ 
animal if 
needed 
Modifications 
to protocol if 
needed 
IRB 
Notification 
Intro 
Forest 
Walk  
 
 
 
 
 
 
 
Time 1  
 
 
 
 
 
 
Time 2  
 
 
 
 
 
 
Wildlife 
Activity I 
 
 
 
 
 
 
 
Time 1  
 
 
 
 
 
 
Time 2  
 
 
 
 
 
 

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Wildlife 
Activity 
II 
 
 
 
 
 
 
 
Time 1  
 
 
 
 
 
 
Time 2  
 
 
 
 
 
 
Wildlife 
Activity 
III  
 
 
 
 
 
 
 
Time 1  
 
 
 
 
 
 
Time 2  
 
 
 
 
 
 
 
 
Psychological Evaluation: The PCL-5 will be conducted at baseline and post study. A Soldier On 
mental health counselor will be available by phone during the administration of the PCL-5 test in 
case the test exacerbates any psychological symptoms. Psychological surveys will be entered 
within one week and monitored for significant increase. If any individuals have a high baseline 
score for anxiety or depression at study enrollment (as defined in literature) or a > 25% increase 
over baseline anxiety or depression scores, the participant will be referred for counseling at 
Soldier On via contacting the individual’s Soldier On Case Manager. The case manager will be 
contacted via a secure email using “SEND SECURE” in the subject line. The email will include 
the participant’s first name and last initial, name of test, normal test parameters, participant’s 
score and comparison to baseline if applicable.   Participants with any medical or psychological 
symptoms that occur during the activities will be referred to clinical services at Soldier On 
(which has clinical staff) or VA (which is located at same campus as Soldier On) via referral to 
the case manager. If any participants notify staff of exacerbation of psychological symptoms 
between activities, they will also be referred to Soldier On/ VA services. If an urgent medical or 
psychological issue occurs in the field, the study team would call 911 to have them transferred to 
closest hospital facility. The protocol will be finalized with the study advisory board once 
convened. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
Participants may be withdrawn from study without their consent if they exhibit behavior 
indicating active addiction or intoxication which is in violation of the inclusion criteria or if they 
engage in behavior which places any other participants or study staff at risk or if they engage in 
animal cruelty behaviors. Additionally they may be removed if they:    
• Have an adverse event that requires stopping the research 
• The research is canceled by the FDA or the sponsor 
• Are unable to attend the activities as scheduled.  
 
16. RISKS TO SUBJECTS* 
Risks include: 
• Potential loss of identifiable data 
• Animal bite or scratch 
• Exposure to animal disease 

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• Exacerbation of psychological symptoms 
• Psychological distress due to seeing injured, dying or deceased animals 
• Substance abuse exacerbation 
• Triggering of psychological symptoms due to unexpected noises in external environment 
• Tick bite during outdoor walk 
• Allergy exposure 
• Sun exposure 
• Fatigue/ dehydration during activities 
• Traffic accident in route to or from activity   
• Contracting Covid-19  
Protection against risks 
Recruitment and Informed Consent 
The PI will meet with each potential participant to review the study including potential risks and 
benefits.  Participants will provide informed voluntary consent.  
 
Participants will be accompanied during activities by the PI, a registered nurse.  All wildlife-
related activities will be preceded by education and guided by an expert in wildlife care. Risk-
specific preventative measures will be taken as below.  If any unexpected adverse events occur 
the event will be given immediate attention at the site (such as first aid if needed) and participant 
will be referred for appropriate medical or psychological care.  The PI will bring a first aid kit 
and Narcan nasal spray as a precaution for all activities.  
 
All study sites are < 19 miles from a local hospital (ranging from on site to 18.1 miles) 
• Soldier On (On campus of VA Hospital in Pittsfield, MA) 
• Harvard Forest-Athol Memorial Hospital (4.2 miles) 
• Mass Audubon Broad Meadow Brook- UMass Memorial Medical Center (4.9 miles) 
• Maine Wildlife Park-Central Maine Medical Center  (18.1 miles-highway interstate 
travel) 
 
Confidentiality: The following steps will be taken to ensure that all patient data remain 
confidential.  
(1) Use of numeric identifiers: To ensure confidentiality, study assessments and electronically 
stored data will be identified only by a unique identifier. The master list linking the patient ID to 
the patient’s identifying information will be maintained in a separate file and will be destroyed at 
the conclusion of the study. Signed consent forms will be kept in locked filing cabinets and will 
only be accessible to the PI and staff listed on the IRB approval. 
(2) Data storage: No identifying information will be stored with survey responses, or within the 
analytic database. All paper data collection documents will be stored in locked file cabinets 
within locked offices that are accessible only to the project investigators and staff. Signed 
consents will be kept in a separate file from participant data.  Access to the electronic data will 
be restricted to investigators and research staff using a designated research drive. Electronic data 
will be password protected to guard against unauthorized access. 
(3) Staff training: All project staff will pass the CITI exam on ethical conduct of research. Any 
newly hired study staff will pass the web-based CITI exam as required by the University of 

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Massachusetts Medical School Institutional Review Board for the Protection of Human Subjects. 
In addition, study staff will receive training and supervision regarding patient confidentiality. 
This training will be directed by Dr. Perry. The training will address the rights of patients to keep 
participation decision (yes or no) and all assessment data private and confidential. Training will 
also emphasize that discussion or disclosure of any information obtained from research 
participants during the course of the study is strictly prohibited. Prior to having any direct contact 
with research participants, the project assistant will receive training in recruitment and 
assessment procedures.  
(4) Handling of published data and reports: Published data derived from this study will consist 
of statistical analyses collapsed (averaged) across participants. Qualitative data will contain 
direct quotes that participants have shared but no personable identifiable information will be 
linked to the quote. Under no circumstances will data from individual participants be identifiable 
in reports or published manuscripts.  
 
 
Risk 
Protective Measures 
➢ Potential loss of 
identifiable data 
➢ As described above. 
➢ Animal bite or scratch 
 
➢ Proper instruction prior to activities 
➢ Follow facility protocols 
➢ In the event of incident, first aid will be applied 
and participant will be referred to VA facility at 
Soldier On for follow up 
➢ PI will undergo wilderness first aid course prior 
to study initiation 
➢ Exposure to animal 
disease 
 
➢ Use of gloves in wildlife veterinary hospital 
➢ Follow facility protocols 
➢ No activities with animals in isolation ward 
➢ No handling of raccoons due to being rabies 
vector 
➢ Exclusion of individuals with severe 
immunocompromised status   
➢ Instructions for handwashing provided 
➢ Exacerbation of 
psychological 
symptoms 
 
➢ The PCL-5 test will be administered by the PI, a 
registered nurse, with a  mental health clinician 
from Soldier On available by telephone in the 
event that any individuals develop psychological 
symptoms when taking the test 
➢ Ongoing assessment by PI, RN 
➢ An action plan will be developed with Soldier 
On for acute referral for any psychological 
distress; for stable symptoms we will notify  the 
individual’s case manager at  Soldier On for 
referral to appropriate services including VA 
located by Soldier On; for acute emergency in 

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the field PI will call 911 for patient to be brought 
to local ED.  The case manager will also be 
notified if any field emergencies occur. 
➢ Psychological distress 
due to seeing injured 
animals 
➢ Animals on exhibit at Maine Wildlife Park are 
largely healthy 
➢ At New England Wildlife Center we will focus 
activities primarily on healthy babies and 
animals with stable injuries.   
➢ Substance abuse 
exacerbation (we 
anticipate some of 
population will have 
co-morbidities of 
substance abuse) 
➢ Inclusion criteria of 30 days or more free of 
drugs or alcohol abuse and willingness not to use 
substances before or during activities 
➢ Participants will be instructed not to use 
substances before or during activity trips; if any 
participants arrive for activity with signs of 
being under the influence of substances they will 
be asked to stay home that day; if any 
participants become impaired due to substance 
use during activities they will be asked to stay 
near van under observation of Soldier On project 
assistant. 
➢ If any participants notify staff of exacerbation of 
psychological symptoms between activities, they 
will be referred to Soldier On/ VA services via 
notification of case manager. 
➢ If any substance abuse exacerbation occurs 
during the activities participants will be referred 
to Soldier On/ VA services via notification of  
case manager. 
➢ If any participant becomes physically or 
cognitively compromised the PI will call 911 for 
transport to local ED. 
➢ PI will carry Narcan nasal spray in the event of 
participant overdose; PI will undergo training 
prior to study implementation 
➢ Triggering of 
psychological 
symptoms due to 
unexpected noises in 
external environment. 
➢ Due to the potential for distant gunfire from a 
rural gun club or seasonal hunters near the 
Harvard Forest (as well as a wide range of 
possible noises in any public environment) we 
have included that risk in the consent form and 
added a question to the activity evaluation 
regarding stress from environmental sounds/ 
events. Additionally, the PI has contacted the 
gun club to ascertain that no large scale target 
shooting events are scheduled during the times 
when the study activities will take place.   

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➢ Tick bite during 
outdoor walk 
➢ PI will bring tick spray on all activity trips and 
will encourage use by each participant 
➢ Participants will be instructed to monitor self for 
tick bites following activity and to call VA MD 
if any bites occur 
➢ Sun exposure 
➢ Although outdoor activities will primarily be in 
shaded areas PI will provide participants with 
sunscreen as a precaution 
➢ Allergy exposure   
➢ Participants with severe outdoor allergies 
excluded; participants with mild-moderate 
allergies encouraged to take medication prior to 
outdoor activities 
➢ Fatigue/ dehydration 
from activities 
➢ A boxed lunch will be provided each day along 
with ample bottled water  
➢ Possible traffic 
accident in route to or 
from activity 
 
➢ Use of drivers and vehicles owned and operated 
by Soldier On or Professional bus/ van service  
➢ Contracting Covid-19  
➢ We will include only individuals that have been: 
(A) fully vaccinated for Covid-19 and are up to 
date with booster. Fully vaccinated is defined by 
the CDC as: 
o 2 weeks after second dose in a 2-dose 
series, such as the Pfizer or Moderna 
vaccines, or 
o 2 weeks after a single-dose vaccine, such 
as Johnson & Johnson’s Janssen vaccine 
     *Up to date = 1 booster when eligible 
https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/stay-up-to-date.html 
OR 
o (B) Partially vaccinated against Covid-19 
and willing/able to (a) complete a home 
antigen test for Covid-19 on the morning 
of each activity and report results to the 
PI prior to transportation departure and 
(b) willing to wear a mask during 
transportation to and from the activity. 
Antigen tests and masks will be provided 
to participants who meet this criteria. 
• Individuals who have been vaccinated but who 
have a condition or take medications that 
weaken their immune system will be advised to 
follow their physician’s recommendations 
regarding any additional precautions. 

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• We will follow all Covid-19 precautions as 
indicated by state and institutional policies/ 
guidelines as well as Soldier On policies. 
• Individuals who develop Covid-19 symptoms or 
have a positive antigen test prior to a scheduled 
activity will be asked to self-exclude from 
attending that activity, notify research assistant 
and to contact their health care provider. These 
symptoms include: Fever or chills; cough; 
shortness of breath or difficulty breathing; 
fatigue; muscle or body aches; headache; new 
loss of taste or smell; sore throat; congestion or 
runny nose; nausea or vomiting; or diarrhea. 
https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html 
• Individuals who have been diagnosed with 
Covid-19 or exposed to a person with Covid-19 
will be asked not to participate in activities until 
their isolation/ quarantine period is over. 
 
 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
 
We anticipate that the activities in this study will be enjoyable to participants given data from the 
PIs prior studies at two of the locations.  Additionally, participants may receive benefits through 
improvements to psychological and/or physical well-being.  Moreover, we hope that the 
provision of the bird feeders and education might provide sustainable benefits in the future 
beyond study conclusion. Participants will also be provided with a journal for personal use if 
they would like to document future experiences observing wildlife.  
 
18. VULNERABLE POPULATIONS* 
 
a. No inducements, monetary or otherwise, will be offered to terminate a pregnancy 
b. Individuals engaged in the research will have no part in any decisions as to the 
timing, method, or procedures used to terminate a pregnancy 
c. Individuals engaged in the research will have no part in determining the viability 
of a neonate 
 
19. MULTI-SITE RESEARCH* 
N/A 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
N/A 
 

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21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
A presentation of the results will be provided on site at Soldier On following the conclusion of 
the study. Soldier On will also be provided with a copy of any publications that result from the 
study. Participants will have the opportunity to provide their contact information to the research 
team during intake if they want to be notified about results in future.  
 
22. SETTING 
We will partner with a successful veteran’s organization, an internationally-renowned forest 
facility and three wildlife facilities that have expert staff well versed in helping the public to 
experience wildlife safely. Two of these (New England Wildlife Center and Maine Wildlife 
Park) have been sites for the PI’s prior study. Letters of support have been written by all these 
facilities.  
-Soldier On: This private non-profit organization provides housing and support services to 
veterans (currently approximately 600 veterans served) and UMASS Chan Medical School 
faculty have been partnering with them on research for the past 10 years. They have a nationally 
known model of sustainable affordable housing for veterans. Veterans will be recruited through 
Soldier On. Soldier On has multiple vehicles and drivers and has agreed to transport the veteran 
participants to the wildlife activity sites.25, 26    
-Harvard Forest: This 4,000 acre forest of Harvard University was founded in 1907. The Forest 
is a Long-Term Ecological Research Site, funded by the NSF for research into forest dynamics. 
It has multiple walking/hiking trails including accessible trails. (Petersham, MA)27  
-New England Wildlife Center: The NEWC provides veterinary care to orphaned and injured 
wildlife. The Center integrates care with teaching to share skills and knowledge with people of 
all ages. NEWC staff are experienced with integrating novices into animal care including a 
highly successful animal care program for inmates. (South Weymouth, MA)28 
-Maine Wildlife Park: The MWP is a wildlife education center on 40 acres operated by the 
Maine Dept. of Inland Fisheries and Wildlife. The park has 100 animals (30 species) of native 
Maine wildlife living in a sanctuary setting. (Gray, ME)29   
-Mass Audubon Broad Meadow Brook Conservation Center and Wildlife Sanctuary: This 
center is the largest urban wildlife sanctuary in New England with over 400 acres including 
educational facilities and a universally accessible sensory trail. (Worcester, MA)30 
 
Privacy 
• When recording heart rate the participants will be given a card and asked to record their 
heart rate by looking at their wrist monitor. Data will be written rather than spoken aloud. 
• The focus groups will be held in a private room at Soldier On. 
• We will schedule the interviews/ phone calls so that participants can plan in advance to 
be in a private space. 
 
 
23. RESOURCES AVAILABLE 
Describe study personnel.  
 
Roles  
 

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Principal Investigator 
The principal investigator will manage  all aspects of the study including IRB approval. This 
includes:   
• Oversee the conduct of all facets of this study, including human subjects review, 
communication with team members, collaboration with community wildlife facilities, 
research-related activities; personal oversight of intervention activities, budget; 
compliance and scientific integrity; 
• Be responsible for the IRB submission and overseeing human subjects procedures of all 
participants enrolled in the study;   
• Conduct training of personnel and ensure that personnel have taken courses in Good 
Clinical Practice and CITI training 
• Ensure that research personnel have training in all study-related procedures and standards 
to ensure intervention fidelity procedures are maintained.   
• Meet with individuals recruited by Soldier On Research  Assistant to screen for study 
eligibility and enroll as study participants 
• Conduct baseline study measures 
• Schedule intervention activities in collaboration with Soldier On and community facilities  
• Refine animal-assisted activities in collaboration with Advisory Committee 
• Accompany study participants during activities at community wildlife facilities 
• Conduct all study measures pre and post activities 
• Oversee data collection, data management and quality control with particular emphasis 
on data accuracy; including working with study statistician to structure the primary 
datasets, data linking procedures, codebook development and data documentation and 
security procedures.  
• Perform qualitative data analysis  
• Responsible for execution (along with Co-I) of the data safety monitoring plan.   
• Work with the research team to prepare manuscripts, coordinate study results 
dissemination activities and prepare R01 for the full scale study. 
 
• Co-Investigator Provide ongoing advisement to the research team as a senior scientist;  
• Assist with analysis and interpretation of the data 
• Serve as Safety Officer which will include reviewing monthly safety report with PI   
• Consult on abstracts and manuscripts developed from the study and development of plan 
for future R01.   
 
• Co-Investigator Design the final intervention study analysis plan in consultation with PI 
and other Co-I 
• Be responsible for ensuring that the statistical design is implemented according to plan;   
• Be responsible for the statistical integrity of the intervention study;  
• Assist with execution of the data safety monitoring plan; 
• Conduct, report and write up of final feasibility study analyses; 
• Consult on abstracts and manuscripts developed from the study and development of 
statistical analysis plan for future R01.   
 

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Research Assistant (UMass Chan Medical School) 
A research assistant will be hired to assist with study logistics, data collection and data entry. 
The research assistant will undergo CITI training and will report directly to Dr. Perry.    
 
Community Partner (subcontract) 
Soldier On is a private non-profit organization that provides housing and support services to 
veterans. One of the co-investigators has a strong working relationship with Soldier On from 
prior research. Veterans will be recruited through Soldier On for the study.  Soldier On will 
undertake the following: 
• Appoint a site advisor to serve as lead representative of Soldier On in this study Hire a 
research assistant to recruit participants for the study and assist with activity logistics. 
The research assistant will be CITI trained and listed as study staff. 
• Provide transportation to study activities using Soldier On vehicles and drivers 
 
Consultants 
We will have three expert consultants, one representing each of the facility settings where 
animal-assisted intervention will take place.  Of note is that the PI  has worked extensively with 
two of the consultants, in her previous study. 
Advisory Committee: We will convene an advisory committee to inform refinement and 
logistics of the intervention protocol prior to start of study, after year 1 and after study 
conclusion.  Initial meetings will be held individually in order to focus on unique aspects of each 
site.  
 
The role of the consultants is primarily to advise and assist with the study intervention rather 
than the research. Two of the consultants and possibly the third will likely be providing facility 
orientation and possibly some education for the participants as they are part of the staff at the 
facilities. They will not have access to identifiable research information or data. The lead person 
at Soldier On may have awareness of who are study participants and may be asked to assist with 
referrals for medical or psychiatric care if needed. This person will undergo CITI training. Other 
members of the advisory committee will be providing feedback on the study planning/logistics 
only. 
 
24. LOCAL RECRUITMENT METHODS 
Sample/ recruitment  
We will recruit a total of 50 veterans with PTSD/ PTSD symptoms from Soldier On, a residential 
facility that currently serves 600 veterans. Recruitment flyers will be posted in residential 
buildings and also provided to potential candidates by Soldier On mental health clinicians and 
case managers. Interested individuals will be advised to contact the Soldier On research assistant 
who will conduct preliminary screening and schedule an initial meeting with the PI for obtaining 
consent and baseline data collection. During the fall/ winter period when active recruitment is 
not taking place any individuals who contact the research assistant regarding study participation 
will be assigned an ID number and will have their contact information documented in the secure 
research drive by the research assistant. Individuals will be told that they will be contacted for 
screening when enrollment resumes (anticipated approximately  April 2020).   The recruiter/ 
research assistant will be hired through a subcontract to Soldier On. Given that Soldier On is a 

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residential facility with two locations within 25 miles from each other, the recruiter will also 
identify people through their community meetings. The PI may attend some community 
meetings to introduce herself and describe the study. Soldier On has a specific program for 
women veterans and we anticipate being able to recruit a minimum of 5 women from this 
program.  
 
The inclusion/exclusion criteria will be assessed via self-report. The research assistant at Soldier 
On will conduct screening for inclusion criteria and exclusion criteria using a designated form. 
 
Of note, we include individuals with PTSD and subthreshold trauma (clinical symptoms without 
full diagnostic criteria22) both to increase our sample size and have a broad inclusion criteria for 
generalizability. Once deemed eligible, they will undergo informed consent by PI, be 
administered the baseline study measures and assigned to an activity group. We will recruit 30 
veterans in Year I and 20 in Year II.  
Our relationship with Soldier On and an on-site research assistant will also facilitate retention.  
Dr. Smelson (Co-I) has a long standing relationship of working with Soldier On and has obtained 
follow up rates above 80%. The Soldier On research assistant will contact each participant as a 
reminder 1 day prior to each activity.  Additionally we anticipate that the wildlife activities will 
be enjoyable for participants.  Participants will be provided with transportation and lunch.    We 
will also provide the following remuneration for their time and to facilitate retention.   
Activities 1- 7: $30 Bank of America gift card  
Activity 8 (final activity): $100 Bank of America gift card 
F/U interview/ phone call (20 minutes): $30 Bank of America gift card  
A total of $340 will be provided for the 8 activities and follow up interview/ phone call.*   
 
A wearable wrist fitness sensor will be provided to each participant for recording heart rate 
which will be given to each participant at study conclusion. Each participant will also be 
provided with a bird identification book during the final set of activities in order to facilitate 
sustainable wildlife-related activity. A certificate of attendance will be provided to participants 
when they complete the program as long as they attend at least 6 of the 8 activities.  
 
 
*Provision of all gift cards requires that each participant’s name, address and telephone number 
be provided to the University of Massachusetts Medical School Business Office according to 
institutional policy. The vendor (Bank of America) will mail the cards to participants directly.  
Cell phone information is already collected and stored in the R Drive for participant 
communication and all participants reside at Soldier On. If any individual leaves Soldier On 
prior to receiving their gift cards they will be requested to provide their new address. W-9, 
including social security number will also be collected in order to comply with UMass Chan 
Business Office policy. Addresses will be removed from the research records within 3 years after 
study conclusion. Contact information sheets will be retained for those participants who 
requested to be provided with study results at study conclusion.   
25. LOCAL NUMBER OF SUBJECTS 
50 
 

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26. CONFIDENTIALITY  
Describe the data and/or specimens.  
Baseline measures collected will include:  
• Demographic information: age; gender; race, ethnicity, education, branch of service; 
tours of deployment; medical history; substance use; medications; allergies 
• Physiologic measures: heart rate; noninvasive stress markers such as heart rate are 
preferable as they reduce stress induced by collection48 
• Psychological measures 
o PCL-5 
o Warwick-Edinburgh Mental-Well Being Scale (14 items)43,44 
o Speilberger state/trait anxiety inventory (6 items)45  
o Center for Epidemiologic Studies Depression (CES-D-10) scale (10 items).46 
o Short-form Nature-Relatedness (NR-6) (6 items) 49 
o Human-wildlife Bridging Feelings of Valuation Scale20 
• Animal observation journal exercise during Maine Wildlife Park visits 
Pre/Post activity measures will include: 
Physiological measures (heart rate before and after every activity at each site) 
Psychological survey measures (after activity at each site)  
Study conclusion: Focus groups and PCL-5 
4-6 week F/U after final study activity: Phone/ in person interview 
All scales will be completed on paper surveys, collected by the PI and stored in a locked research 
office.   
Confidentiality: The following steps will be taken to ensure that all patient data remain 
confidential.  
(1) Use of numeric identifiers: To ensure confidentiality, study assessments and electronically 
stored data will be identified only by a unique identifier. The master list linking the patient 
ID to the patient’s identifying information will be maintained in a separate file and will be 
destroyed at the conclusion of the study. Signed consent forms will be kept in locked filing 
cabinets and will only be accessible to the PI and staff listed on the IRB approval. 
(2) During study activities participants will be provided with a name tag for personal 
communication with study team and facility staff that provides their first name. If there are two 
individuals with the same first name in a cohort the initial of the last name will be included.  
 
(3) Data storage:  
Recruitment data will be entered into a UMass Chan Research Drive using an encrypted laptop 
maintained by the research assistant to include only name, contact information and inclusion 
criteria screening.  This file will be destroyed at study conclusion.  The screening data file will 
contain an ID number that will correspond to research data files but kept separately.   Audio files 
will be securely transferred with encryption or via a UMMS IT sanctioned method, such as Move 
IT. Audio files will be destroyed once the transcriptions are checked for quality. 
 
Activity data will be collected by PI in conjunction with research assistant. Post activity data will 
include written surveys, journal entries, and heart rate records. Data will be collected by PI and 
research assistants.  
 

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There will be only two  journal entries per participant andthey  will be conducted during  the 
visits to the Maine Wildlife Park. This will be an exercise in which participants will be given a 
card/ heavy paper to write on describing their experience observing an animal of their choice. 
Each card will be pre-labelled with the participant’s ID number. The text of the responses will be 
entered into a word document and the original will be destroyed after it has been entered. The PI 
will analyze the journal descriptions using content analysis. 
 
Post study data will additionally include focus group recordings/ transcripts and F/U phone/in-
person interview data. Participant IDs will be used with all data. No identifying information will 
be stored with these data or within the analytic database. All paper data collection documents 
will be stored in locked file cabinets within locked offices that are accessible only to the project 
investigators and staff. Access to the electronic data will be restricted to investigators and 
research staff using a designated research drive. Electronic data will be password protected to 
guard against unauthorized access. 
 
(3) Staff training: All project staff will pass the CITI exam on ethical conduct of research. Any 
newly hired study staff will pass the web-based CITI exam as required by the University of 
Massachusetts Medical School Institutional Review Board for the Protection of Human Subjects. 
In addition, study staff will receive training and supervision regarding patient confidentiality. 
This training will be directed by Dr. Perry. The training will address the rights of patients to keep 
participation decision (yes or no) and all assessment data private and confidential. Training will 
also emphasize that discussion or disclosure of any information obtained from research 
participants during the course of the study is strictly prohibited. Prior to having any direct contact 
with research participants, the project assistant will receive training in recruitment and 
assessment procedures.  
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Recruitment and screening will be conducted with individual participants within a private office. 
For post activity data participants will be provided with a place to sit and write their answers. 
Responses will not be spoken.  The heart rate data will be obtained by the participant writing 
their heart rate on a card or the the PI or research assistant looking at the wrist device and will 
not be spoken aloud.  The focus group at the end of the study will be conducted as a group but 
participants will be told they only need answer questions they feel comfortable with.  Post study 
interviews/ phone calls will be scheduled at a time during which individual can be in a private 
setting.   
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
There is no compensation for research-related injury in this study. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
There will be no costs to participants for this study.  
 
30. CONSENT PROCESS 
The research assistant will meet individually with potential participants to explain the study and 
conduct screening for inclusion criteria. The research assistant will provide a consent form at that 

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time for the participant to take home and read. Individuals will be then be scheduled in small 
groups for a second meeting at which time the PI will explain the study and obtain informed 
consent. Baseline demographics and measures will also be done at that time as described earlier. 
The PI will also meet individually with each participant to clarify any demographic questions 
and to allow time for any private questions.   . The time between initial recruitment and the 
consent meeting will allow for a time period for participants to reflect on their decision. They 
will also be told they can stop the study at any time. 
The study team will adhere to HRP-802 INVESTIGATOR GUIDANCE: Informed Consent 
(https://www.umassmed.edu/ccts/irb/investigator-guidance/). 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
Consent will be obtained in writing and will be done by the PI.  
The study team will adhere to HRP-803 INVESTIGATOR GUIDANCE: Documentation of 
Informed Consent (https://www.umassmed.edu/ccts/irb/investigator-guidance/). 
 
32. DRUGS OR DEVICES 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 

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eIRB Section 7.0 Attachments Upload Checklist 
Follow How to Manage Files in eIRB and upload the following items as applicable to your 
submission. This checklist is provided for your convenience and is not a requirement for review. 
 
 
Investigator Study Plan 
 
Sponsor protocol 
 
Research portion of the grant 
 
Human subjects portion of the grant 
 
Written approvals from ancillary reviews (Clinical Engineering, COI, IBC, PRC, RSC, 
Students as Subjects, etc.) 
 
Recruitment materials such as flyers, brochures, posters, scripts of radio ads, etc. 
 
Data collection sheets, case report forms, etc. 
 
Surveys, measures, instruments, etc. 
 
Measures to assess capacity to consent 
 
DMC or DSMB charter 
 
Data safety monitoring plan 
 
Adverse event log 
 
Investigator brochure or package insert for drugs  
 
Instructions for use or approved FDA labeling for devices 
 
Sponsor justification or FDA documentation for non-significant risk device study  
 
IND or IDE documentation 
 
Patient information sheet for Humanitarian Use Device 
 
Approval order for Humanitarian Use Device 
 
Product labeling for Humanitarian Use Device 
 
HIPAA waiver 
 
HIPAA authorization 
 
Authorization to contact form 
 
Consent form(s) 
 
Assent forms(s) 
 
Fact sheet(s) 
 
Multi-site communication plan 
 
Study staff training plan 
 
SOPs or Manuals of Operations 
 
Screening log 
 
Compensation log 
 
Certificates of translation or translator attestations 
 
Data use agreements, memoranda of understanding,  
 
Documentation of data/specimen anonymity (i.e., provider will never break the code) 
 
 
 
 
 
 

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References 
 
1. Nimer, J. & Lundahl, B. (2007). Animal-assisted therapy: A meta-analysis. Anthrozoös. 20(3), 
225-238. 
2. O’Haire, M.E., Guérin, N.A. & Kirkham, A.C, (2015). Animal-assisted intervention for trauma: 
A systematic literature review. Frontiers in Psychology, 6: 1121, 1-12. 
3. Esposito, L., McCune, S., Griffin, J.A. & Maholmes, V. (2011). Directions in human–animal 
interaction research: Child development. Health, and Therapeutic Interventions. Child 
Development Perspectives, 5(3), 205-211. 
4. Kruger, K.A. & Serpell, J.A. (2006).  Animal-Assisted Interventions in Mental Health: 
Definitions and Theoretical Foundations. Handbook on Animal-Assisted Therapy. Theoretical 
Foundations and Guidelines for Practice, 2cnd Ed. 21-38.  
5. American Psychiatric Association, What is post-traumatic stress disorder? Web site. Retrieved 
3/3/18 from https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd 
6. Krause-Parello, C.A., Sarni, S.& Padden, E. (2015). Military veterans and canine assistance for 
post-traumatic stress disorder: A narrative review of the literature. Nurse Education Today (47), 
43–50. 
7. Furst, G. (2016). Helping war veterans with post-traumatic stress disorder: Incarcerated 
individuals’ role in therapeutic animal programs. Journal of Psychosocial Nursing, 54(5), 49-57.  
8. Rumayor, C.B. & Thrasher, A.M. (2017). Reflections on recent research into animal-assisted 
interventions in the military and beyond. Current Psychiatry Reports, 19(2), 110, 1-7.  
9. O’Haire, M.E., Guérin, N.A., Kirkham, A.C. & Daigle, C.L. (2015, Aug. 25). Animal-assisted 
intervention for trauma, including post-traumatic stress disorder. HABRI Central Brief, 1-8. 
10. Frumkin, H., Bratman, G.N., Breslow, S.J., Cochran, B., Kahn, P.H., Lawler, J.J., Levin, P.S., 
Tandon, P.S., Varanasi, U., Wolf, K.L. & Wood, S.A. (2017, July 31). Nature contact and human 
health: A research agenda. Environmental Health Perspectives, 125(7), 075001-1-18 
11. Williams, F. (2017). The Nature Fix: Why Nature Makes Us Happier, Healthier, and More 
Creative. New York: W.W. Norton & Company. 
12. Cox, D.T.C. & Gaston, K.J. (2015, Nov. 11). Likeability of garden birds: Importance of species 
knowledge & richness in connecting people to nature. PLOS ONE, 10(11), 1-14. 
13. Largo-Wight, E., O’Hara, B.K. & Chen, W.W. (2016). The efficacy of a brief nature sound 
intervention on muscle tension, pulse rate, and self-reported stress: Nature contact micro-break in 
an office or waiting room, Health Environments Research & Design Journal, 10(1) 45-5. 
14. Brock, M., Perino, G. & Sugden, R. (2017). The warden attitude: An investigation of the value of 
interaction with everyday wildlife. Environmental Resource Economics, 67, 127-155. 
15. Curtin, S. (2009, Sept.-Nov.). Wildlife tourism: the intangible, psychological benefits of human–
wildlife encounters. Current Issues in Tourism, 12(5-6), 451–474. 
16. Cox, D.T.C., Shanahan, D.F., Hudson, H.L., Plummer, K.E., Siriwardena, G.M., Fuller, R.A., 
Anderson, K., Hancock, S., & Gaston, K.J. (2017, Feb. 1). Doses of neighborhood nature: The 
benefits for mental health of living with nature. Bioscience, 67(2), 147–155. 
17. Horn, D.J. & Johansen, S.A. (2013, June). A comparison of bird-feeding practices in the United 
States and Canada. Wildlife Society Bulletin, 37(2), 293-300. 
18. Banziger, Z  & Roush, S. (1983, Oct.). Nursing homes for the birds: A control relevant 
intervention with bird feeders. The Gerontologist. 23(5), 527-531. 
19. Furst, G (2006, Dec.) Prison-based animal programs: A national survey. The Prison Journal, 
86(4), 407-430. 

H00016795: Wildlife and Wellbeing 
November 11, 2022 
INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 29 of 30 
Template Revised 8/8/2017 
20. Perry. D.J., Averka, J., Johnson, C., Cavanaugh, A. & Powell, H. (submitted and in review).  
Feelings toward Moose and Coyote in a Maine Wildlife Sanctuary: Testing the Human-Wildlife 
Bridging Feelings of Valuation Scale.  
21. Zelenski, J.M. & Nisbet, E.K. (2014). Happiness and feeling connected. The distinct role of 
nature relatedness. Environment and Behavior, 46(1), 3-23.  
22. Kasckow, J., Yeager, D.E., Magruder, K. (2015, Jan.). Levels of symptom severity and 
functioning in four different definitions of subthreshold posttraumatic stress disorder in primary 
care veterans. The Journal of Nervous and Mental Disease, 203(1), 43-47. 
23. Blevins, C.A., Weathers, F.W., Davis, M.T., Witte, T.K. & Domino, J.L. (2015, Dec.). The 
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and initial 
psychometric evaluation. Journal of Traumatic Stress 28, 489-498. 
24. Veterans Affairs, PCL-5. Retrieved 3/1/18 from https://www.mirecc.va.gov/cih-
visn2/Documents/Clinical/PCL-5_with_Info_Sheet.pdf 
25. Soldier On web site. Retrieved 3/9/2018 from https://www.wesoldieron.org/ 
26. Personal communication, J. Downing, 3/5/18 
27. Harvard Forest web site. Retrieved 3/3/18 from http://harvardforest.fas.harvard.edu/about-us 
28. New England Wildlife Center web site. Retrieved 3/3/18 from https://www.newildlife.org/about-
2/ 
29. Maine Wildlife Park web site. Retrieved 3/3/18 from https://www.maine.gov/ifw/wildlife-
park/index.html 
30. Mass Audubon Broad Meadow Brook Conservation Center and Wildlife Sanctuary. Retrieved 
3/3/18 from https://www.massaudubon.org/get-outdoors/wildlife-sanctuaries/broad-meadow-
brook 
31. Perry, D.J. (2015, Oct.-Dec.). Transcendent pluralism: A middle-range theory of nonviolent 
social transformation through human dignity. Advances in Nursing Science, 38(4), 317-329. 
32. Perry, D.J. (2011).  The Israeli-Palestinian Peace Movement: Combatants for Peace. New York: 
Palgrave Macmillan. 
33. Andrews, Ted. Animal speak: The spiritual & magical powers of creatures great & small.  
Woodbury, MN: Llewellyn Publications, 2014. 
34. Sams, Jamie and Carson, David. Medicine cards, New York: St. Martin’s Press, 1988/1999. 
35. Perry, D.J., (manuscript in preparation). Human-animal relations in the context of wildlife 
rehabilitation.  
36. Perry, D.J. (2016, Fall). The patterned and emergent boundaries of wilderness beings: Ponderings 
on the creature at the edge of the woods.  Humanimalia, 8(1),93-110. 
37. Wellek, S. & Blettner, M. (2012). On the proper use of the crossover design in clinical trials. 
Deutsches Ärzteblatt International, 109(15), 276–81. 
38. Slagle, K., Zajac, R., Bruskotter, J., Wilson, R. & Prange, S. (2013). Building tolerance for bears: 
A communications experiment. The Journal of Wildlife Management, 77 (4), 863-9. 
39. Sponarski, C.C., Vaske, J.J., Bath, A.J. & Loeffler, TA. (2016). Changing attitudes and emotions 
toward coyotes with experiential education. Journal of Environmental Education, 47(4), pp. 296-
306. 
40. Anestis, M.D., Anestis, J.C., Zawilinski, L.L., Hopkins, T.A. & Lilienfeld, S.O. (2014) Equine-
related treatments for mental disorders lack empirical support: A systematic review of empirical 
investigations Journal of Clinical Psychology, 70(12), 1115-1132. 
41. Newman, M., Smith, M.C., Pharris, M.D., & Jones, D. (2008).  The focus of the discipline 
revisited.  Advances in Nursing Science, 31, E16-E27.  
42. Lonergan, Bernard JF. 1957/ 2000. Insight: A study of human understanding. 5th Ed., vol. 3 of 
Collected Works of Bernard Lonergan. Eds. Frederick E. Crowe and Robert M. Doran (Toronto: 
University of Toronto Press). 

H00016795: Wildlife and Wellbeing 
November 11, 2022 
INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 30 of 30 
Template Revised 8/8/2017 
43. Perry, D. J. (2013, Aug.). Transcendental method for research with human subjects: A 
transformative phenomenology for the human sciences.  Field Methods, 25(3), 262-282. 
44. Tennant, R., Hiller, L., Fishwick, R., Platt, S., Joseph, S., Welch, S., Parkinson, J., Secker, J., 
Stewart-Brown.  (2007, Nov. 27). The Warwick-Edinburgh Mental Well-being Scale 
(WEMWBS): development and UK validation. Health and Quality of Life Outcomes, 5(63), 1-13. 
45. Warwick-Edinburgh Mental Well-being Scale. Warwick Medical School. Web site. Retrieved 
3/9/18 from https://warwick.ac.uk/fac/med/research/platform/wemwbs/ 
46. Marteau, T.M. and Bekker, H. (1992). The development of a six-item short-form of the state scale 
of the Spielberger State-Trait Anxiety Inventory (STAI). British Journal of Clinical Psychology, 
(31),301-306. 
47. Mohebbi, M., Nguyen, V., McNeil, J.J., Woods, R.L., Nelson, M.R., Shah, R.C., Storey, E., 
Murray, A.M., Reid, C.M., Kirpach, B., Wolf, R., Lochery, J.E. & Berk, M. (2017, Aug. 18). 
Psychometric properties of a short form of the Center for Epidemiologic Studies Depression 
(CES-D-10) scale for screening depressive symptoms in healthy community dwelling older 
adults. General Hospital Psychiatry, Epub, 1-8. 
48. Krause-Parello, C.A., Levy, C., Holman, E. & Kolassa, J.E. (2018). Effects of VA facility dog on 
hospitalized veterans seen by a palliative care psychologist: An Innovative Approach to 
Impacting Stress Indicators. American Journal of Hospice & Palliative Medicine, 35(1), 5-14. 
49. Marques, A.H., Silverman, M.N. & Sternberg, E.M. (2010). Evaluation of stress systems by 
applying noninvasive methodologies: Measurements of neuroimmune biomarkers in the sweat, 
heart rate variability and salivary cortisol. NeuroImmunoModulation, 17,205–208. 
50. Nisbet, E.K. & Zelensky, J.M. (2013, Nov.), The NR-6: a new brief measure of nature 
relatedness. Frontiers in Psychology, 4/ Art. 813, 1-11. 
51. Kraemer, H.C., Mintz, J., Noda, A., Tinklenberg, J. & Yesavage J.A. (2006). Caution regarding 
the use of pilot studies to guide power calculations for study proposals. Archives of General 
Psychiatry; 63:484-9. 
52. Leon, A.C., Davis, L.L. & Kraemer, H.C. (2011). The role and interpretation of pilot studies in 
clinical research. Journal of Psychiatric Research, 45, 626-9. 
53. Smelson, D., Pinals, D.A., Sawh, L, Fulwiler, C., Singer, S., Guevremont, N., Fisher, W., 
Steadman, H.J., & Hartwell, S. (2015). An alternative to incarceration: Co-Occurring Disorders 
Treatment Intervention for Justice-Involved Veterans. World Medical & Health Policy, 7(4), 329-
348. 
54. Carmody, J.F., Crawford, S., Salmoirago-Blotcher, E., Leung, K., Churchill, L. & Olendzki, N. 
(2011). Mindfulness training for coping flashes: results of a randomized trial. Menopause, 18(6), 
611-620 
55. Kish, L. (1965). Survey Sampling. New York: Wiley. 
56. Fitzmaurice, G.M., Laird, N.M. & Ware, J.H. (2004). Applied Longitudinal Analysis; New York: 
Wiley. 
57. Little, R.J.A. & Rubin, D.B. (2002). Statistical analysis with missing data, 2nd ed. New York: 
Wiley, 2002. 
58. Senn, S. Crossover Trials in Clinical Research. New York: Wiley, 1993 
59. Creswell, J. (2013). Qualitative Inquiry & Research Design: Choosing Among Five Approaches, 
3rd Ed. Los Angeles: Sage.