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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116489
• Other study ID #: H00016795
• Secondary ID: 1R21HD097771
• Status: Completed
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Other:
• Forest walk
Participants will be provided with an educational program about the forest and take a guided forest walk.
• Wildlife rehabilitation
Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
• Wildlife sanctuary observation
Participants will be provided an educational program on wildlife care and accompany park game keepers during animal feeding and will observe iconic wildlife.
• Bird feeding and watching
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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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