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

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ClinicalTrials.gov Identifier: NCT04116489
Recruitment Status : Active, not recruiting
First Posted : October 4, 2019
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Donna Perry, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Other: Forest walk Other: Wildlife rehabilitation Other: Wildlife sanctuary observation Other: Bird feeding and watching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wildlife Immersion Activity
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 .
Other: Forest walk
Participants will be provided with an educational program about the forest and take a guided forest walk.

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

Other: 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.

Other: 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.




Primary Outcome Measures :
  1. Incidence of recruitment and retention of study participants [ Time Frame: Through study completion, approximately 12 weeks per participant ]
    Recruitment and retention of study participants will be measured in order to determine the feasibility of delivering a wildlife program to veterans with PTSD.

  2. Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, approximately 12 weeks per participant ]
    Incidence will be measured through a safety log of adverse events.

  3. Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) [ Time Frame: Through study completion, approximately 12 weeks per participant ]
    Participant acceptance of the intervention will be assessed through observation by PI during activities.

  4. Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) through activity evaluation [ Time Frame: Through study completion, approximately 12 weeks per participant ]
    Participant acceptance of the intervention will be measured through activity evaluation forms at the end of each activity.

  5. Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) through focus group feedback [ Time Frame: Through study completion, approximately 12 weeks per participant ]
    Participant acceptance of the intervention will be measured through focus groups following the last activity.

  6. Acceptance of intervention to veterans with Post Traumatic Stress Disorder (PTSD) [ Time Frame: 4 weeks after study conclusion ]
    Participant acceptance of the intervention will be assessed a follow up phone call with each participant approximately 4 weeks after study conclusion.

  7. 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.

  8. 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.

  9. Change in anxiety [ Time Frame: Baseline to study conclusion (approximately 12 weeks per participant). ]
    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.

  10. 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

  11. Change in participant stress based on salivary cortisol levels [ Time Frame: Baseline through study conclusion (approximately 12 weeks per participant). ]

    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


  12. Change in participant stress based on heart rate [ Time Frame: Baseline through study conclusion (approximately 12 weeks per participant). ]
    Participant stress will be measured by heart rate via wearable wrist sensor


Secondary Outcome Measures :
  1. Change in relation to nature [ Time Frame: Baseline to study conclusion (approximately 12 weeks per participant). ]
    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.

  2. Change in feelings of valuation toward wildlife base on Transcendent Feelings of Animal Valuation [ Time Frame: Baseline to study conclusion (approximately 12 weeks per participant). ]
    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.

  3. Change in connection with wildlife based on observation journal [ Time Frame: After activities 5 and 6 at Maine Wildlife Park (up to 2-3 weeks per participant). ]
    Connection with wildlife will be measured through a wildlife observation/ journal exercise with open ended questions

  4. Change in connection with wildlife based on optional study extension journal activity [ Time Frame: 8 weeks ]
    Connection with wildlife will be assessed through an optional study extension journal activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans with PTSD/PTSD symptoms (per self report)
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116489


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Donna J Perry UMass Medical School
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Responsible Party: Donna Perry, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04116489    
Other Study ID Numbers: H00016795
1R21HD097771 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders