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Veterans Nature Therapy (Vet Hike)

Primary Purpose

Posttraumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group nature hikes
Group urban hikes
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Posttraumatic Stress Disorders focused on measuring posttraumatic stress disorders, randomized controlled trial, pilot study, feasibility, nature, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nature hiking

Urban hikes

Arm Description

Group hikes in a natural setting (e.g., park, wilderness area)

Group hikes in a urban setting (e.g., downtown area)

Outcomes

Primary Outcome Measures

Recruitment
Time to recruit the sample
Recruitment
Percentage of individuals contacted who are randomized
Retention
Percentage of participants that complete assessments

Secondary Outcome Measures

PTSD symptoms
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), 20 items, range 0-80; summed; higher = greater PTSD
Quality of life/well-being: Satisfaction with Life Scale
Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction
Depression
Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression
Perceived stress
Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress
Social connectedness
4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group
Rumination
State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination

Full Information

First Posted
June 12, 2019
Last Updated
June 9, 2021
Sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System, Recreational Equipment, Inc. (REI)
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1. Study Identification

Unique Protocol Identification Number
NCT03997344
Brief Title
Veterans Nature Therapy (Vet Hike)
Official Title
Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System, Recreational Equipment, Inc. (REI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders
Keywords
posttraumatic stress disorders, randomized controlled trial, pilot study, feasibility, nature, physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of two arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nature hiking
Arm Type
Experimental
Arm Description
Group hikes in a natural setting (e.g., park, wilderness area)
Arm Title
Urban hikes
Arm Type
Active Comparator
Arm Description
Group hikes in a urban setting (e.g., downtown area)
Intervention Type
Behavioral
Intervention Name(s)
Group nature hikes
Other Intervention Name(s)
Nature hikes
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group urban hikes
Other Intervention Name(s)
Urban hikes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment
Description
Time to recruit the sample
Time Frame
Baseline
Title
Recruitment
Description
Percentage of individuals contacted who are randomized
Time Frame
Baseline
Title
Retention
Description
Percentage of participants that complete assessments
Time Frame
12-week follow-up
Secondary Outcome Measure Information:
Title
PTSD symptoms
Description
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), 20 items, range 0-80; summed; higher = greater PTSD
Time Frame
Baseline and 6-, 12-, 24-week follow-ups
Title
Quality of life/well-being: Satisfaction with Life Scale
Description
Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction
Time Frame
Baseline and 6-, 12-, 24-week follow-ups
Title
Depression
Description
Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression
Time Frame
Baseline and 6-, 12-, 24-week follow-ups
Title
Perceived stress
Description
Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress
Time Frame
Baseline and 6-, 12-, 24-week follow-ups
Title
Social connectedness
Description
4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group
Time Frame
Baseline and 6-, 12-, 24-week follow-ups
Title
Rumination
Description
State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination
Time Frame
Baseline and 6-, 12-, 24-week follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson Littman, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34556516
Citation
Littman AJ, Bratman GN, Lehavot K, Engel CC, Fortney JC, Peterson A, Jones A, Klassen C, Brandon J, Frumkin H. Nature versus urban hiking for Veterans with post-traumatic stress disorder: a pilot randomised trial conducted in the Pacific Northwest USA. BMJ Open. 2021 Sep 23;11(9):e051885. doi: 10.1136/bmjopen-2021-051885.
Results Reference
derived

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Veterans Nature Therapy (Vet Hike)

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