VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
NCT Number: NCT03997344
This pilot study evaluates the feasibility of conducting a study to evaluate the impact of nature exposure/hiking in groups on symptoms of posttraumatic stress disorder in Veterans. Participants will be randomized to one of two groups: 1) nature hikes and 2) urban hikes.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Nature hikes
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: Urban hikes
Time frame: Baseline
Time to recruit the sample
Time frame: Baseline
Percentage of individuals contacted who are randomized
Time frame: 12-week follow-up
Percentage of participants that complete assessments
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
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress
Time frame: Baseline and 6-, 12-, 24-week follow-ups
4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group
Time frame: Baseline and 6-, 12-, 24-week follow-ups
State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination
University of Washington
Other
Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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