Stress Disorders, Post-TraumaticNCT04116489
Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
A study testing Forest walk, Wildlife rehabilitation and Wildlife sanctuary observation in people with Stress Disorders, Post-Traumatic, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Forest walk, Wildlife rehabilitation and Wildlife sanctuary observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Forest walk, Wildlife rehabilitation, Wildlife sanctuary observation, Bird feeding and watching
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest walkOther
Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitationOther
Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
Wildlife sanctuary observationOther
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 watchingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Other: Forest walk; Other: Wildlife rehabilitation; Other: Wildlife sanctuary observation; Other: Bird feeding and watching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: Approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start5 Jul 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Donna Perry, University of Massachusetts, Worcester
- Investigators
- Donna J Perry, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116489
- Sponsor's protocol ID
- H00016795
- Other IDs
- 1R21HD097771
- Status last verified
- Sep 2024
- First submitted
- 22 Jul 2019
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT04116489
- Acronym / sponsor ID
- H00016795
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wildlife Immersion Activity | Experimental | Other: Forest walk, Other: Wildlife rehabilitation, Other: Wildlife sanctuary observation, Other: Bird feeding and watchingWe 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 . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Veterans with PTSD/PTSD symptoms (per self report)
- Fully vaccinated against Covid-19, which is defined by the CDC as:
- Age 18-70
- Comfortable interacting with animals
- Sufficient mobility to walk or navigate wheelchair up to one mile at leisurely pace
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forest walkParticipants will be provided with an educational program about the forest and take a guided forest walk. | Other | Wildlife Immersion Activity |
| Wildlife rehabilitationParticipants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals. | Other | Wildlife Immersion Activity |
| Wildlife sanctuary observationParticipants will be provided an educational program on wildlife care and accompany park game keepers during animal feeding and will observe iconic wildlife. | Other | Wildlife Immersion Activity |
| Bird feeding and watchingParticipants 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. | Other | Wildlife Immersion Activity |
Primary outcome
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.
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.
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.
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
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.
Retention of Participants
Time frame: Approximately 12 weeks
Number of participants who complete the study in comparison to those who enrolled in study (19)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna J Perry principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest walk, Wildlife rehabilitation and Wildlife sanctuary observation in people with Stress Disorders, Post-Traumatic, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Recruitment of Study Participants (time frame: at recruitment, day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.