Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD

Study Overview
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Brief Summary
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This study investigates a novel approach to animal-assisted interventions through a series of wildlife immersion activities (wildlife observation, wildlife rehabilitation and bird feeding/watching) for veterans who have suffered trauma as part of their military duty. Findings from this study will advance scientific knowledge about the benefits of wildlife activities for veterans with PTSD including the acceptability, feasibility, safety and preliminary influence on physical and mental well-being. The findings will be instrumental in advancing a new area of health intervention research for veterans in settings that are publicly accessible and family-oriented for sustainable, low-cost interventions with potential application in other populations.

Detailed Description
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This study utilized a crossover design. The intervention included an introductory forest walk followed by 3 wildlife immersion activity experiences in different settings that offered different ways to experience wildlife. This included an introductory forest walk, a wildlife rehabilitation center, a wildlife sanctuary and a bird watching program. Each activity was conducted twice to minimize potential anxiety and novelty effects. Activities were conducted in small groups to provide peer support.

Official Title
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Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Other: Forest walk
* Other: Wildlife rehabilitation
* Other: Wildlife sanctuary observation
* Other: Bird feeding and watching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans with PTSD/PTSD symptoms (per self report) Fully vaccinated against Covid-19, which is defined by the CDC as: 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 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 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 against Covid-19 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wildlife Immersion Activity<br>We will use a crossover design in which each participant receives an introductory forest walk followed by 3 wildlife immersion activity experiences in different settings . | Other: Forest walk<br>* Participants will be provided with an educational program about the forest and take a guided forest walk.<br>Other: Wildlife rehabilitation<br>* Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.<br>Other: Wildlife sanctuary observation<br>* Participants will be provided an educational program on wildlife care and accompany park game keepers during animal feeding and will observe iconic wildlife.<br>Other: Bird feeding and watching<br>* Participants will learn about bird identification and safe bird feeding. Bird feeders will be provided at the Soldier On facility for home bird feeding after study conclusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of recruitment and retention of study participants | Recruitment and retention of study participants will be measured in order to determine the feasibility of delivering a wildlife program to veterans with PTSD. | Through study completion, approximately 12 weeks per participant | 
| Incidence of treatment-emergent adverse events | Incidence will be measured through a safety log of adverse events. | Through study completion, approximately 12 weeks per participant | 
| Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) | Participant acceptance of the intervention will be assessed through observation by PI during activities. | Through study completion, approximately 12 weeks per participant | 
| Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) through activity evaluation | Participant acceptance of the intervention will be measured through activity evaluation forms at the end of each activity. | Through study completion, approximately 12 weeks per participant | 
| Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) through focus group feedback | Participant acceptance of the intervention will be measured through focus groups following the last activity. | Through study completion, approximately 12 weeks per participant | 
| Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) | Participant acceptance of the intervention will be assessed a follow up phone call with each participant approximately 4 weeks after study conclusion. | 4 weeks after study conclusion | 
| Change in Post Traumatic Stress Disorder (PTSD) symptoms | PTSD symptoms will be measured with the Posttraumatic Stress Disorder Checklist (PCL-5) which is a 20-item measure that assesses PTSD symptoms. Scores range from 0-80 with 33 or higher suggesting a provisional PTSD diagnosis. | Baseline to study conclusion (approximately 12 weeks per participant). | 
| Change in perception of well being | Perception of well being will be measured with the Warwick Edinburgh Mental Well Being Scale which is a 14 item instrument with scores ranging from 14 to 70. Higher scores indicate higher perceived well being. | Baseline to study conclusion (approximately 12 weeks per participant). | 
| Change in anxiety | Participant anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (short form), a 6-item measure. The total score range is 20-80 with a higher score indicating higher anxiety. | Baseline to study conclusion (approximately 12 weeks per participant). | 
| Change in depression | Participant depression will be measured by the Center for the Epidemiological Study of Depression short form (CES-D-10) a 10 item instrument with a score range of 0-30 with higher scores indicating higher level of depression | Baseline to study conclusion (approximately 12 weeks per participant). | 
| Change in participant stress based on salivary cortisol levels | Participant stress will be measured via salivary cortisol levels. Normal ranges are:8-10 AM - 0.04-0.56 mcg/dL; Noon-2 PM - ≤0.21 mcg/dL; 4-6 PM - ≤0.15 mcg/dL; 10 PM-1 AM. Higher levels generally indicate higher stress although awakening cortisol can be reduced in chronic stress. ≤0.09 mcg/dL | Baseline through study conclusion (approximately 12 weeks per participant). | 
| Change in participant stress based on heart rate | Participant stress will be measured by heart rate via wearable wrist sensor | Baseline through study conclusion (approximately 12 weeks per participant). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in relation to nature | Connection to nature will be measured by the Nature Relatedness scale (short form) a 6-item scale. Scores range from 1-6 with a higher score indicating a stronger relationship to nature. | Baseline to study conclusion (approximately 12 weeks per participant). | 
| Change in feelings of valuation toward wildlife base on Transcendent Feelings of Animal Valuation | Feelings of valuation toward wildlife will be measured by the Transcendent Feelings of Animal Valuation scale a 7-item instrument with scores ranging from 7-35 with higher scores indicating more positive feelings of valuation toward wildlife. | Baseline to study conclusion (approximately 12 weeks per participant). | 
| Change in connection with wildlife based on observation journal | Connection with wildlife will be measured through a wildlife observation/ journal exercise with open ended questions | After activities 5 and 6 at Maine Wildlife Park (up to 2-3 weeks per participant). | 
| Change in connection with wildlife based on optional study extension journal activity | Connection with wildlife will be assessed through an optional study extension journal activity | 8 weeks |