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Completed

NCT Number: NCT03997344

Veterans Nature Therapy (Vet Hike)

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group nature hikes

Behavioral

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

Group urban hikes

Behavioral

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

Primary outcomes

  1. Recruitment

    Time frame: Baseline

    Time to recruit the sample

  2. Recruitment

    Time frame: Baseline

    Percentage of individuals contacted who are randomized

  3. Retention

    Time frame: 12-week follow-up

    Percentage of participants that complete assessments

Secondary outcomes

  1. 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

  2. Quality of life/well-being: Satisfaction with Life Scale

    Time frame: Baseline and 6-, 12-, 24-week follow-ups

    Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction

  3. Depression

    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

  4. Perceived stress

    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

  5. Social connectedness

    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

  6. Rumination

    Time frame: Baseline and 6-, 12-, 24-week follow-ups

    State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Recreational Equipment, Inc. (REI)
  • VA Puget Sound Health Care System

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2019
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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