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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forest walk
Wildlife rehabilitation
Wildlife sanctuary observation
Bird feeding and watching
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wildlife Immersion Activity

Arm Description

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 .

Outcomes

Primary Outcome Measures

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.
Incidence of treatment-emergent adverse events
Incidence will be measured through a safety log of adverse events.
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.
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.
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.
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.
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.
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.
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.
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
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
Change in participant stress based on heart rate
Participant stress will be measured by heart rate via wearable wrist sensor

Secondary Outcome Measures

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.
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.
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
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

Full Information

First Posted
July 22, 2019
Last Updated
May 11, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04116489
Brief Title
Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
Official Title
Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wildlife Immersion Activity
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Forest walk
Intervention Description
Participants will be provided with an educational program about the forest and take a guided forest walk.
Intervention Type
Other
Intervention Name(s)
Wildlife rehabilitation
Intervention Description
Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
Intervention Type
Other
Intervention Name(s)
Wildlife sanctuary observation
Intervention Description
Participants will be provided an educational program on wildlife care and accompany park game keepers during animal feeding and will observe iconic wildlife.
Intervention Type
Other
Intervention Name(s)
Bird feeding and watching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of recruitment and retention of study participants
Description
Recruitment and retention of study participants will be measured in order to determine the feasibility of delivering a wildlife program to veterans with PTSD.
Time Frame
Through study completion, approximately 12 weeks per participant
Title
Incidence of treatment-emergent adverse events
Description
Incidence will be measured through a safety log of adverse events.
Time Frame
Through study completion, approximately 12 weeks per participant
Title
Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD)
Description
Participant acceptance of the intervention will be assessed through observation by PI during activities.
Time Frame
Through study completion, approximately 12 weeks per participant
Title
Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) through activity evaluation
Description
Participant acceptance of the intervention will be measured through activity evaluation forms at the end of each activity.
Time Frame
Through study completion, approximately 12 weeks per participant
Title
Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) through focus group feedback
Description
Participant acceptance of the intervention will be measured through focus groups following the last activity.
Time Frame
Through study completion, approximately 12 weeks per participant
Title
Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD)
Description
Participant acceptance of the intervention will be assessed a follow up phone call with each participant approximately 4 weeks after study conclusion.
Time Frame
4 weeks after study conclusion
Title
Change in Post Traumatic Stress Disorder (PTSD) symptoms
Description
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.
Time Frame
Baseline to study conclusion (approximately 12 weeks per participant).
Title
Change in perception of well being
Description
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.
Time Frame
Baseline to study conclusion (approximately 12 weeks per participant).
Title
Change in anxiety
Description
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.
Time Frame
Baseline to study conclusion (approximately 12 weeks per participant).
Title
Change in depression
Description
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
Time Frame
Baseline to study conclusion (approximately 12 weeks per participant).
Title
Change in participant stress based on salivary cortisol levels
Description
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
Time Frame
Baseline through study conclusion (approximately 12 weeks per participant).
Title
Change in participant stress based on heart rate
Description
Participant stress will be measured by heart rate via wearable wrist sensor
Time Frame
Baseline through study conclusion (approximately 12 weeks per participant).
Secondary Outcome Measure Information:
Title
Change in relation to nature
Description
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.
Time Frame
Baseline to study conclusion (approximately 12 weeks per participant).
Title
Change in feelings of valuation toward wildlife base on Transcendent Feelings of Animal Valuation
Description
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.
Time Frame
Baseline to study conclusion (approximately 12 weeks per participant).
Title
Change in connection with wildlife based on observation journal
Description
Connection with wildlife will be measured through a wildlife observation/ journal exercise with open ended questions
Time Frame
After activities 5 and 6 at Maine Wildlife Park (up to 2-3 weeks per participant).
Title
Change in connection with wildlife based on optional study extension journal activity
Description
Connection with wildlife will be assessed through an optional study extension journal activity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna J Perry
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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