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

NCT04116489 | Completed Results

• 2 other identifiers: H000167951R21HD097771
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (6)

• Incidence of Recruitment of Study Participants

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

  at recruitment, day 1

• 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. A higher score is worse.

  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 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 Level of Anxiety

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

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

• Retention of Participants

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

  Approximately 12 weeks

Study Arms (1)

Wildlife Immersion Activity

EXPERIMENTAL

We will use a single group/ modified crossover design in which each participant receives an introductory forest walk followed by 3 wildlife immersion activity experiences in different settings .

Other: Forest walk; Other: Wildlife rehabilitation; Other: Wildlife sanctuary observation; Other: Bird feeding and watching

Interventions

Forest walk OTHER

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

Wildlife Immersion Activity

Wildlife rehabilitation OTHER

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

Wildlife Immersion Activity

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.

Wildlife Immersion Activity

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.

Wildlife Immersion Activity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with PTSD/PTSD symptoms (per self report)
• Fully vaccinated against Covid-19, which is defined by the CDC as:
• weeks after second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

This study was limited by the need to put recruitment and intervention on hold for 1.5 years due to Covid, limiting the sample size.

Results Point of Contact

• Title: Donna Perry, PhD, RN
• Organization: UMass Chan Medical School; Tan Chingfen Graduate School of Nursing

DonnaJ.Perry@umassmed.edu

508-856-3621

Study Officials

• Donna J Perry

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: October 4, 2019
• Study Start: July 5, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)