Stress Disorders, Post-Traumatic
Conditions
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.
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.
Interventions
OTHERForest walk
Participants will be provided with an educational program about the forest and take a guided forest walk.
OTHERWildlife rehabilitation
Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
OTHERWildlife 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.
OTHERBird 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Massachusetts, Worcester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Recruitment of Study Participants | 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 | 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 | 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 | 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 | 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 | Approximately 12 weeks | Number of participants who complete the study in comparison to those who enrolled in study (19) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participant left facility and was no longer eligible | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Wildlife Immersion Activity |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
| Study participants | 19 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 4 / 18 | 1 / 18 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 13 | 0 / 13 |
Outcome results
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
Time frame: Baseline to study conclusion (approximately 12 weeks per participant).
Population: Depression analysis included all participants and was adjusted for # of sessions attended.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wildlife Immersion Activity | Change in Depression | -1.84 score on a scale | Standard Error 1.52 |
p-value: 0.2437Regression, Linear
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.
Time frame: Baseline to after final activity (approximately 12 weeks per participant)
Population: Anxiety analysis included all participants and was adjusted for # of sessions attended.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wildlife Immersion Activity | Change in Level of Anxiety | -7.72 score on a scale | Standard Error 3.42 |
p-value: 0.0373Regression, Linear
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.
Time frame: Baseline to study conclusion (approximately 12 weeks per participant).
Population: Well being analysis included all participants and was adjusted for # of sessions attended.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wildlife Immersion Activity | Change in Perception of Well Being | 3.17 score on a scale | Standard Error 2.19 |
p-value: 0.1657Regression, Linear
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.
Time frame: Baseline to study conclusion (approximately 12 weeks per participant).
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wildlife Immersion Activity | Change in Post Traumatic Stress Disorder (PTSD) Symptoms | -6.56 score on a scale | Standard Error 9.97 |
p-value: 0.5272Regression, Linear
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.
Time frame: at recruitment, day 1
Population: 28 participants that were screened were eligible for the study. 19 of these enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wildlife Immersion Activity | Incidence of Recruitment of Study Participants | 19 participants |
Primary
Retention of Participants
Number of participants who complete the study in comparison to those who enrolled in study (19)
Time frame: Approximately 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wildlife Immersion Activity | Retention of Participants | 14 Participants |