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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD097771 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forest walk | Other | Participants will be provided with an educational program about the forest and take a guided forest walk. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Donna J Perry | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wildlife Immersion Activity | We utilized a crossover design in which each participant received an introductory forest walk followed by 3 wildlife immersion activity experiences in different settings. Each activity was provided twice. Participants participated in each activity in the same order: Forest walk first, then wildlife rehabilitation, then wildlife sanctuary, then bird watching. There were not separate treatment arms. Forest walk: Participants were provided with an educational program about the forest and took a guided forest walk. Wildlife rehabilitation: Participants were provided with education on wildlife rehabilitation and assisted with wildlife care such as feeding baby animals. Wildlife sanctuary observation: Participants were provided an educational program on wildlife care and accompanied park game keepers during animal feeding and observation of wildlife. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Veterans with PTSD
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| ID | Title | Description |
|---|---|---|
| BG000 | Wildlife Immersion Activity | We utilized a modified crossover design in which each participant received an introductory forest walk followed by 3 wildlife immersion activity experiences in different settings. Each activity was completed twice. All participants completed the activities in the same order: Forest walk first, then wildlife rehab, then wildlife sanctuary, then bird watching. Forest walk: Participants were provided with an educational program about the forest and undertook a guided forest walk. Wildlife rehabilitation: Participants were provided with education on wildlife rehabilitation and assisted with wildlife care such as feeding baby animals. Wildlife sanctuary observation: Participants were provided an educational program on wildlife care and observed animal care/ enrichment Bird feeding and watching: Participants were provided with education about bird characteristics and safe bird feeding. Bird feeders were provided for home bird feeding after study conclusion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 28 participants that were screened were eligible for the study. 19 of these enrolled. | Posted | Number | participants | at recruitment, day 1 |
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Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Forest Walk | Forest walk: Participants were provided with an educational program about the forest and took a guided forest walk. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tick on skin (not embedded) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Occurred during Activity 1/ Forest Walk |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Perry, PhD, RN | UMass Chan Medical School; Tan Chingfen Graduate School of Nursing | 508-856-3621 | DonnaJ.Perry@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2022 | Jan 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Wildlife rehabilitation | Other | Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals. |
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| 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. |
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| 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. |
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Number of participants who complete the study in comparison to those who enrolled in study (19)
| Approximately 12 weeks |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Study participants | Number | participants |
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| Primary | 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. | All participants completed the baseline PCL-5 but only participants who finished the study completed the follow-up measure because the follow up survey was administered after the final activity. | Posted | Mean | Standard Error | score on a scale | Baseline to study conclusion (approximately 12 weeks per participant). |
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| Primary | 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. | Well being analysis included all participants and was adjusted for # of sessions attended. | Posted | Mean | Standard Error | score on a scale | Baseline to study conclusion (approximately 12 weeks per participant). |
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| Primary | 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 | Depression analysis included all participants and was adjusted for # of sessions attended. | Posted | Mean | Standard Error | score on a scale | Baseline to study conclusion (approximately 12 weeks per participant). |
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| Primary | 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. | Anxiety analysis included all participants and was adjusted for # of sessions attended. | Posted | Mean | Standard Error | score on a scale | Baseline to after final activity (approximately 12 weeks per participant) |
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| Primary | Retention of Participants | Number of participants who complete the study in comparison to those who enrolled in study (19) | Posted | Count of Participants | Participants | Approximately 12 weeks |
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| 0 |
| 18 |
| 0 |
| 18 |
| 4 |
| 18 |
| EG001 | Wildlife Rehabilitation | Wildlife rehabilitation: Participants were provided with education on wildlife rehabilitation and assisted with wildlife care such as feeding baby animals. | 0 | 18 | 0 | 18 | 1 | 18 |
| EG002 | Wildlife Sanctuary Observation | Wildlife sanctuary observation: Participants were provided an educational program on wildlife care and accompanied park game keepers during animal feeding and observation of wildlife. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Bird Feeding and Watching | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Mild hypoglycemic symptoms during walk | Endocrine disorders | Non-systematic Assessment | Occurred during Activity 1/ Forest Walk |
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| Skin scratch from holding baby squirrel | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Occurred during Activity 2/ Wildlife rehabilitation care |
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| Transient pain from acorn falling on shoulder | General disorders | Non-systematic Assessment | Occurred during Activity 1/ Forest Walk |
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