Posttraumatic Stress Disorders
Conditions
Keywords
posttraumatic stress disorders, randomized controlled trial, pilot study, feasibility, nature, physical activity
Brief summary
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.
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.
Interventions
BEHAVIORALGroup nature hikes
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.
BEHAVIORALGroup urban 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.
Sponsors
VA Puget Sound Health Care System
Recreational Equipment, Inc. (REI)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants are randomly assigned to one of two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Baseline | Time to recruit the sample |
| Retention | 12-week follow-up | Percentage of participants that complete assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline and 6-, 12-, 24-week follow-ups | Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression |
| Perceived stress | Baseline and 6-, 12-, 24-week follow-ups | Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress |
| PTSD symptoms | 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 |
| Rumination | Baseline and 6-, 12-, 24-week follow-ups | State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination |
| Social connectedness | Baseline and 6-, 12-, 24-week follow-ups | 4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group |
| Quality of life/well-being: Satisfaction with Life Scale | Baseline and 6-, 12-, 24-week follow-ups | Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction |
Countries
United States
Outcome results
None listed