NCT03997344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 12, 2019

Last Update Submit

June 9, 2021

Conditions

Keywords

posttraumatic stress disordersrandomized controlled trialpilot studyfeasibilitynaturephysical activity

Outcome Measures

Primary Outcomes (3)

  • Recruitment

    Time to recruit the sample

    Baseline

  • Recruitment

    Percentage of individuals contacted who are randomized

    Baseline

  • Retention

    Percentage of participants that complete assessments

    12-week follow-up

Secondary Outcomes (6)

  • PTSD symptoms

    Baseline and 6-, 12-, 24-week follow-ups

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

    Baseline and 6-, 12-, 24-week follow-ups

  • Depression

    Baseline and 6-, 12-, 24-week follow-ups

  • Perceived stress

    Baseline and 6-, 12-, 24-week follow-ups

  • Social connectedness

    Baseline and 6-, 12-, 24-week follow-ups

  • +1 more secondary outcomes

Study Arms (2)

Nature hiking

EXPERIMENTAL

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

Behavioral: Group nature hikes

Urban hikes

ACTIVE COMPARATOR

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

Behavioral: Group urban hikes

Interventions

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.

Also known as: Nature hikes
Nature hiking

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.

Also known as: Urban hikes
Urban hikes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Schizophrenia, bipolar disorder or other psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticMotor Activity

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavior

Study Officials

  • Alyson Littman, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor: College of the Environment

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 25, 2019

Study Start

May 10, 2019

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations