Effectiveness of Nature Walks in Depressed Adults

November 5, 2021 updated by: Marie-Claude Geoffroy, McGill University

Investigations of Immediate and Short-term Effects of Nature Walks on Stress and Depression-related Symptoms

Over the past few years, a growing number of campaigns from around the world, including Canada, are highlighting the positive impact of spending time in nature on well-¬being. Indeed, mounting evidence suggests that spending time with nature is associated with a myriad of affective and cognitive benefits. Surprisingly few studies to date have tested the assumption that walking in nature versus in urban settings could alleviate stress and depressive symptoms in clinically depressed adults.

The main purpose of this study is to investigate the effectiveness of walking in nature versus in urban settings to improve depression related symptoms and reduce stress. The trial initially included 2 primary outcomes: patients stress levels (salivary cortisol) and depression-related symptoms (eg, affect, rumination, executive functioning).

However, due to hygienic concerns in light of the COVID-19 pandemic in 2020, the collection of saliva samples (and in turn, the measurement of stress levels via salivary cortisol) was removed from the study's procedure. The main outcome was changed to effects on positive and negative affect.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4H 1R3
        • Douglas Mental Health University Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged between 18 and 65 years, inclusively;
  • Ability to speak French or English;
  • Diagnosis major depressive disorder (DSM-IV);

Exclusion Criteria:

  • Acute psychotic symptoms;
  • Acute suicidal intent (within 48 hours);
  • Unable to walk for 60 min or serious medical reasons (e.g. major surgery)
  • Heart condition as per history or detected on electrocardiogram

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Urban

Patients will go for a silent 60-minute walk in an urban setting. The walk will take place in the months of June, July, August and September between 10:00 to 11:00 am.

Participants will walk in groups of two to three participants accompanied by two research assistants trained in mental health (doctoral students in psychology). The urban walk will be located on Boulevard de la Vérendrye with large arteries with three to four lanes.
Behavioral: Walking in Urban setting
Walking for 60 minutes as described above
EXPERIMENTAL: Nature

Patients will go for a silent 60-minute walk in a nature park setting. The walk will take place in the months of June, July, August and September between 10:00 to 11:00 am.

Participants will walk in groups of two to three participants accompanied by two research assistants trained in mental health (doctoral students in psychology).

The nature walk will take place at Parc Angrignon, an area of 96 hectares, one of Montreal's largest green and biodiverse spaces with a forest of 20 000 trees and a pond surrounded by willow trees.
Behavioral: Walking in nature setting
Walking for 60 minutes as described above

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in affect from baseline up to 48 hours post-walk
Time Frame: Day 1 to Day 3
Positive and Negative Affect Schedule (PANAS)
Day 1 to Day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Executive Functions
Time Frame: The Stroop test will be administered at 2 time points: 1) before the walk (between 9:45-10:30); 2) after the walk (between 11:30-11:50)
The stroop color word test is a widely used task to assess selective attention and inhibitory control. In the first block of this task (A), color words (red, blue, yellow, green) printed in black ink are presented in random order and participants are asked to read out loud the words. In the second block (B), solid color patches in one of the same four colors are shown and participants name the colors. Finally, in the third block (C), color words are printed in an incongruous ink color and participants must name the ink color (e.g. GREEN [typed in red]; response = red). Participants are asked to complete each block as quickly and accurately as possible and the time to complete each trial is calculated and averaged for each block. An interference score is calculated as followed: C - [(A + B) /2].
The Stroop test will be administered at 2 time points: 1) before the walk (between 9:45-10:30); 2) after the walk (between 11:30-11:50)
Change in suicidal Ideations
Time Frame: Day 1
Severity of Suicidal Ideations The severity of current suicidal ideation will be assessed with three items derived from a prior study of momentary assessment of suicidal risk: "How intense is your desire to kill yourself right now"?; "How strong is your intention to kill yourself right now"?; "How strong is your ability to resist the urge to kill yourself right now"? Each item is scored on a scale from 0 (not strong [intense] at all) to 4 (very strong [intense]).
Day 1
Change in depressive symptoms
Time Frame: Day 1 to Day 2
The Beck Depression Inventory (BDI-II) The BDI is a widely used 21-item depression inventory with good internal consistency (α = .93 in the current sample) and validity. Items are answered on a 4-point scale from 0 to 3.
Day 1 to Day 2
Change in rumination
Time Frame: Day 1
The Rumination-Reflection Questionnaire (RRQ) The RRQ is a 24-item self-reported questionnaire assessing both self-rumination and self-reflection, 57 with 12 items corresponding to each subscale. Participants rate the degree to which they engage in self- rumination (e.g. "sometimes it is hard for me to shut off thoughts about myself") and self-reflective thoughts (e.g. "I love to meditate on the nature and meaning of things") on a Likert scale ranging from one (strongly disagree) to five (strongly agree)
Day 1
Change in irritability
Time Frame: Day 1 to Day 3
The Brief Irritability Test (BITe): The BITe is a 5-item self-report measure of irritability that is suitable for use among men and women. Participants respond to statements using a 6-point Likert scale ranging from Never to Always. Items include the following five statements: "I have been grumpy"; "I have been feeling like I might snap"; "Other people have been getting on my nerves".
Day 1 to Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Social Sciences and Humanities Research Council of Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Claude Geoffroy, PhD, McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IUSMD-18-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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