- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997344
Veterans Nature Therapy (Vet Hike)
Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives and hypothesis: Posttraumatic stress disorder (PTSD) is a tragically common problem among US Military Veterans. Current treatment options for PTSD are not uniformly effective and dropout rates are high. Treatment approaches that are evidence-based, effective, and acceptable to Veterans are needed. Nature therapy is a promising, low-cost intervention, yet there are few rigorous studies that have evaluated it as a therapeutic intervention in Veterans with PTSD.
The specific aims of this study are to lay the ground work for a full-scale study by assessing the feasibility and acceptability of: i) recruitment, screening, and data collection methods; and ii) the nature hiking and urban hiking control group interventions. The investigators hypothesize that the interventions will be feasible and the recruitment, screening, and data collection methods will be acceptable.
Key eligibility criteria for this two-arm pilot randomized controlled trial include being a Veterans with PTSD, physical fitness/ability sufficient to walk for at least 2 hours, and willingness to complete assessments. Eligible individuals will be randomized to one of two groups: 1) nature hiking group, 2) urban hiking group. The investigators will enroll up to 60 individuals, to randomize up to 15 participants per group. Note that the number enrolled and randomized are not expected to be the same since he investigators anticipate some individuals who enroll will be determined not to be eligible based on responses to the baseline questionnaire. Individuals randomized to groups 1 or 2 will be invited to participate in six hikes of 2-4 hours in duration, over approximately 12 weeks. Individuals will be asked to complete questionnaires at baseline and weekly for 12 weeks, and then again at 24 weeks. The primary outcomes for this study relate to feasibility and acceptability. The investigators will collect information on time to recruit the sample, retention and survey completion at each time point, and attendance at hikes. A secondary aim is to ascertain changes in PTSD symptoms (which will serve as the primary outcome of the full-scale trial), secondary outcomes (e.g., quality of life) and mediators of the intervention, including factors such as depression, perceived stress, affect, loneliness, anxiety, social connectedness, rumination, and nature connection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- U.S. Military Veteran;
- Active PTSD symptoms based on the PCL-5;
- No diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders (based on self-report);
- Low risk of suicide (based on responses to the MINI Suicidal module);
- No inpatient admission in last 3 months (based on self-report);
- No current alcohol disorder/dependence (based on having a score<16 on the 10-item self-administered AUDIT questionnaire);
- No evidence of drug-related problems (based on having a score <3 on the DAST-10)
- Capable of safely participating in hikes as evidenced by no "yes's" on the Physical Activity Readiness Questionnaire (or approval of their primary care physician) and individual assertion that they can walk at least 2 hours at an easy to moderate effort with breaks;
- Willing to be randomized to one of two groups and complete all study procedures;
- Able to provide written informed consent to participate.
Exclusion Criteria:
- Schizophrenia, bipolar disorder or other psychotic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Nature hiking
Group hikes in a natural setting (e.g., park, wilderness area)
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Six group nature hikes will be offered once every other week.
Total duration of intervention is 12 weeks.
Hikes will be co-lead by two experienced hike leaders.
Other Names:
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Active Comparator: Urban hikes
Group hikes in a urban setting (e.g., downtown area)
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Six group urban hikes will be offered once every other week.
Total duration of intervention is 12 weeks.
Hikes will be co-lead by two experienced hike leaders.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment
Time Frame: Baseline
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Time to recruit the sample
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Baseline
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Recruitment
Time Frame: Baseline
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Percentage of individuals contacted who are randomized
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Baseline
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Retention
Time Frame: 12-week follow-up
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Percentage of participants that complete assessments
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12-week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD symptoms
Time Frame: Baseline and 6-, 12-, 24-week follow-ups
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), 20 items, range 0-80; summed; higher = greater PTSD
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Baseline and 6-, 12-, 24-week follow-ups
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Quality of life/well-being: Satisfaction with Life Scale
Time Frame: Baseline and 6-, 12-, 24-week follow-ups
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Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction
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Baseline and 6-, 12-, 24-week follow-ups
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Depression
Time Frame: Baseline and 6-, 12-, 24-week follow-ups
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Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression
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Baseline and 6-, 12-, 24-week follow-ups
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Perceived stress
Time Frame: Baseline and 6-, 12-, 24-week follow-ups
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Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress
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Baseline and 6-, 12-, 24-week follow-ups
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Social connectedness
Time Frame: Baseline and 6-, 12-, 24-week follow-ups
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4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group
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Baseline and 6-, 12-, 24-week follow-ups
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Rumination
Time Frame: Baseline and 6-, 12-, 24-week follow-ups
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State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination
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Baseline and 6-, 12-, 24-week follow-ups
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alyson Littman, PhD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006745
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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