Veterans Nature Therapy (Vet Hike)

Posttraumatic Stress Disorders Clinical Trial

Official title:

Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997344
• Other study ID #: STUDY00006745
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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