Trial Outcomes & Findings for Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD (NCT NCT04116489)
NCT ID: NCT04116489
Last Updated: 2024-10-16
Results Overview
Recruitment of study participants will be measured in order to determine the feasibility of delivering a wildlife program to veterans with PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
at recruitment, day 1
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Participant left facility and was no longer eligible
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Wildlife Immersion Activity
n=19 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
|
Study participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at recruitment, day 1Population: 28 participants that were screened were eligible for the study. 19 of these enrolled.
Recruitment of study participants will be measured in order to determine the feasibility of delivering a wildlife program to veterans with PTSD.
Outcome measures
| Measure |
Wildlife Immersion Activity
n=28 Participants
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 .
Forest walk: Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitation: Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
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.
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.
|
|---|---|
|
Incidence of Recruitment of Study Participants
|
19 participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Wildlife Immersion Activity
n=14 Participants
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 .
Forest walk: Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitation: Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
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.
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.
|
|---|---|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms
|
-6.56 score on a scale
Standard Error 9.97
|
PRIMARY outcome
Timeframe: Baseline to study conclusion (approximately 12 weeks per participant).Population: Well being analysis included all participants and was adjusted for # of sessions attended.
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.
Outcome measures
| Measure |
Wildlife Immersion Activity
n=19 Participants
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 .
Forest walk: Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitation: Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
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.
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.
|
|---|---|
|
Change in Perception of Well Being
|
3.17 score on a scale
Standard Error 2.19
|
PRIMARY outcome
Timeframe: Baseline to study conclusion (approximately 12 weeks per participant).Population: Depression analysis included all participants and was adjusted for # of sessions attended.
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
Outcome measures
| Measure |
Wildlife Immersion Activity
n=19 Participants
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 .
Forest walk: Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitation: Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
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.
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.
|
|---|---|
|
Change in Depression
|
-1.84 score on a scale
Standard Error 1.52
|
PRIMARY outcome
Timeframe: Baseline to after final activity (approximately 12 weeks per participant)Population: Anxiety analysis included all participants and was adjusted for # of sessions attended.
Anxiety will be measured by the Speilberger State/Trait Anxiety Inventory 6-item scale. Range is 20-80 with higher score being worse.
Outcome measures
| Measure |
Wildlife Immersion Activity
n=19 Participants
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 .
Forest walk: Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitation: Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
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.
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.
|
|---|---|
|
Change in Level of Anxiety
|
-7.72 score on a scale
Standard Error 3.42
|
PRIMARY outcome
Timeframe: Approximately 12 weeksNumber of participants who complete the study in comparison to those who enrolled in study (19)
Outcome measures
| Measure |
Wildlife Immersion Activity
n=19 Participants
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 .
Forest walk: Participants will be provided with an educational program about the forest and take a guided forest walk.
Wildlife rehabilitation: Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
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.
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.
|
|---|---|
|
Retention of Participants
|
14 Participants
|
Adverse Events
Forest Walk
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Wildlife Rehabilitation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Wildlife Sanctuary Observation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bird Feeding and Watching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Forest Walk
n=18 participants at risk
Forest walk: Participants were provided with an educational program about the forest and took a guided forest walk.
|
Wildlife Rehabilitation
n=18 participants at risk
Wildlife rehabilitation: Participants were provided with education on wildlife rehabilitation and assisted with wildlife care such as feeding baby animals.
|
Wildlife Sanctuary Observation
n=13 participants at risk
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
n=13 participants at risk
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.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Tick on skin (not embedded)
|
11.1%
2/18 • Number of events 2 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/18 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
|
Endocrine disorders
Mild hypoglycemic symptoms during walk
|
5.6%
1/18 • Number of events 1 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/18 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
|
Skin and subcutaneous tissue disorders
Skin scratch from holding baby squirrel
|
0.00%
0/18 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
5.6%
1/18 • Number of events 1 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
|
General disorders
Transient pain from acorn falling on shoulder
|
5.6%
1/18 • Number of events 1 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/18 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
0.00%
0/13 • Baseline to study conclusion, up to approximately 12 weeks per participant.
Number of participants at risk is derived from # that attended each particular activity.
|
Additional Information
Donna Perry, PhD, RN
UMass Chan Medical School; Tan Chingfen Graduate School of Nursing
Phone: 508-856-3621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place