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Completed

NCT Number: NCT04116489

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forest walk

Other

Participants will be provided with an educational program about the forest and take a guided forest walk.

Wildlife rehabilitation

Other

Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.

Wildlife sanctuary observation

Other

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

Other

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 outcomes

  1. Incidence of Recruitment of Study Participants

    Time frame: at recruitment, day 1

    Recruitment of study participants will be measured in order to determine the feasibility of delivering a wildlife program to veterans with PTSD.

  2. Change in Post Traumatic Stress Disorder (PTSD) Symptoms

    Time frame: Baseline to study conclusion (approximately 12 weeks per participant).

    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. A higher score is worse.

  3. Change in Perception of Well Being

    Time frame: Baseline to study conclusion (approximately 12 weeks per participant).

    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.

  4. Change in Depression

    Time frame: Baseline to study conclusion (approximately 12 weeks per participant).

    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

  5. Change in Level of Anxiety

    Time frame: Baseline to after final activity (approximately 12 weeks per participant)

    Anxiety will be measured by the Speilberger State/Trait Anxiety Inventory 6-item scale. Range is 20-80 with higher score being worse.

  6. Retention of Participants

    Time frame: Approximately 12 weeks

    Number of participants who complete the study in comparison to those who enrolled in study (19)

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2019
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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