Clinical trial NCT04116489: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-10-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 single group/ modified 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.

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

Primary outcomes:
measure: Incidence of Recruitment of Study Participants
timeFrame: at recruitment, day 1
measure: Change in Post Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: Baseline to study conclusion (approximately 12 weeks per participant).
measure: Change in Perception of Well Being
timeFrame: Baseline to study conclusion (approximately 12 weeks per participant).
measure: Change in Depression
timeFrame: Baseline to study conclusion (approximately 12 weeks per participant).
measure: Change in Level of Anxiety
timeFrame: Baseline to after final activity (approximately 12 weeks per participant)
measure: Retention of Participants
timeFrame: Approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Donna J Perry
role: PRINCIPAL_INVESTIGATOR
References: