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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03997344
Other study ID # STUDY00006745
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2019
Est. completion date March 1, 2020

Study information

Verified date June 2021
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Group 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.
Group 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.

Locations

Country Name City State
United States VA Puget Sound Health Care System Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Recreational Equipment, Inc. (REI), VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment Time to recruit the sample Baseline
Primary Recruitment Percentage of individuals contacted who are randomized Baseline
Primary Retention Percentage of participants that complete assessments 12-week follow-up
Secondary PTSD symptoms Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), 20 items, range 0-80; summed; higher = greater PTSD Baseline and 6-, 12-, 24-week follow-ups
Secondary Quality of life/well-being: Satisfaction with Life Scale Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction Baseline and 6-, 12-, 24-week follow-ups
Secondary Depression Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression Baseline and 6-, 12-, 24-week follow-ups
Secondary Perceived stress Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress Baseline and 6-, 12-, 24-week follow-ups
Secondary Social connectedness 4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group Baseline and 6-, 12-, 24-week follow-ups
Secondary Rumination State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination Baseline and 6-, 12-, 24-week follow-ups
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