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Veterans Nature Therapy (Vet Hike)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997344
Recruitment Status : Active, not recruiting
First Posted : June 25, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Recreational Equipment, Inc. (REI)
Information provided by (Responsible Party):
Gregory Bratman, University of Washington

Brief Summary:
This 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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Behavioral: Group nature hikes Behavioral: Group urban hikes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to one of two arms
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nature hiking
Group hikes in a natural setting (e.g., park, wilderness area)
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.
Other Name: Nature hikes

Active Comparator: Urban hikes
Group hikes in a urban setting (e.g., downtown area)
Behavioral: 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.
Other Name: Urban hikes




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997344


Locations
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United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
VA Puget Sound Health Care System
Recreational Equipment, Inc. (REI)
Investigators
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Principal Investigator: Gregory N Bratman, PhD University of Washington
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Responsible Party: Gregory Bratman, Assistant Professor, College of the Environment and Forest Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT03997344    
Other Study ID Numbers: STUDY00006745
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregory Bratman, University of Washington:
posttraumatic stress disorders
randomized controlled trial
pilot study
feasibility
nature
physical activity
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders