Posttraumatic Stress DisordersNCT03997344
Veterans Nature Therapy (Vet Hike)
A study testing Group nature hikes and Group urban hikes in people with Posttraumatic Stress Disorders, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Group nature hikes and Group urban hikes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- Schizophrenia, bipolar disorder or other psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Group nature hikes, Group urban hikes
- Keywords
- posttraumatic stress disorders, randomized controlled trial, pilot study, feasibility, nature, physical activity
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group nature hikesBehavioural
Also called 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 hikesBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Nature hiking | Experimental | Group hikes in a natural setting (e.g., park, wilderness area) Receives: Behavioral: Group nature hikes |
| Urban hikes | Active comparator | Group hikes in a urban setting (e.g., downtown area) Receives: Behavioral: Group urban hikes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Time to recruit the sample
Measured: Baseline
Recruitment
Percentage of individuals contacted who are randomized
Measured: Baseline
Retention
Percentage of participants that complete assessments
Measured: 12-week follow-up
Secondary outcomes (6)
PTSD symptoms
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), 20 items, range 0-80; summed; higher = greater PTSD
Measured: Baseline and 6-, 12-, 24-week follow-ups
Quality of life/well-being: Satisfaction with Life Scale
Satisfaction with Life Scale; 5-items, range 5-35; summed; higher = greater life satisfaction
Measured: Baseline and 6-, 12-, 24-week follow-ups
Depression
Personal Health Questionnaire Depression Scale (PHQ-8); 8-items, range 3-24; summed; higher = greater depression
Measured: Baseline and 6-, 12-, 24-week follow-ups
Perceived stress
Perceived Stress Scale 4 (PSS-4); 4-items, range 0-16; summed; higher = greater stress
Measured: Baseline and 6-, 12-, 24-week follow-ups
Social connectedness
4-item Social Connectedness Scale; 4-items, range 4-28; summed; higher = greater connection to group
Measured: Baseline and 6-, 12-, 24-week follow-ups
Rumination
State rumination- Rumination Reflection Questionnaire 12-items, range 5-60; summed; higher = greater rumination
Measured: Baseline and 6-, 12-, 24-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start10 May 2019
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two arms
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Recreational Equipment, Inc. (REI)
- Responsible party
- Principal investigator, Gregory Bratman, University of Washington
- Investigators
- Alyson Littman, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997344
- Sponsor's protocol ID
- STUDY00006745
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34556516
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03997344
- Acronym / sponsor ID
- STUDY00006745
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- posttraumatic stress disorders, randomized controlled trial, pilot study, feasibility, nature, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Recreational Equipment, Inc. (REI)
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two arms
| Arm | Type | Receives |
|---|---|---|
| Nature hiking | Experimental | Behavioral: Group nature hikesGroup hikes in a natural setting (e.g., park, wilderness area) |
| Urban hikes | Active comparator | Behavioral: Group urban hikesGroup hikes in a urban setting (e.g., downtown area) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (1 listed)
- Schizophrenia, bipolar disorder or other psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group nature hikesAlso: Nature hikesSix 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. | Behavioural | Nature hiking |
| Group urban hikesAlso: Urban hikesSix 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. | Behavioural | Urban hikes |
Primary outcome
Recruitment
Time frame: Baseline
Time to recruit the sample
Recruitment
Time frame: Baseline
Percentage of individuals contacted who are randomized
Retention
Time frame: 12-week follow-up
Percentage of participants that complete assessments
6 secondary outcomes
PTSD symptoms
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Quality of life/well-being: Satisfaction with Life Scale
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Depression
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Perceived stress
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Social connectedness
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Rumination
Time frame: Baseline and 6-, 12-, 24-week follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 34556516Littman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyson Littman, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group nature hikes and Group urban hikes in people with Posttraumatic Stress Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.