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ExperimentalNCT03996785

Effectiveness of Nature Walks in Depressed Adults

A study testing Walking in Urban setting and Walking in nature setting in people with Experimental, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Experimental
What is being tested?
Walking in Urban setting and Walking in nature setting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteCanada
Study dates
18 Jun 2019to 3 Sep 2021
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Douglas Mental Health University Institute

    Montreal, Quebec, H4H 1R3

Other trials in Canada

About this study

Official title: 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.

Conditions
Experimental
Being tested
Walking in Urban setting, Walking in nature setting
Keywords
Clinical depression, Stress, Group-walking, Walking condition (nature vs urban)
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking in Urban settingBehavioural

    Walking for 60 minutes as described above

  • Walking in nature settingBehavioural

    Walking for 60 minutes as described above

Study groups in NCT03996785
Study groupRoleWhat they receive
UrbanActive comparatorPatients 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.
Receives: Behavioral: Walking in Urban setting
NatureExperimentalPatients 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.
Receives: Behavioral: Walking in nature setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in affect from baseline up to 48 hours post-walk

    Positive and Negative Affect Schedule (PANAS)

    Measured: Day 1 to Day 3

Secondary outcomes (5)

  1. Change in Executive Functions

    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].

    Measured: 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)

  2. Change in suicidal Ideations

    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]).

    Measured: Day 1

  3. Change in depressive symptoms

    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.

    Measured: Day 1 to Day 2

  4. Change in rumination

    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)

    Measured: Day 1

  5. Change in irritability

    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".

    Measured: Day 1 to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start18 Jun 2019
  3. Primary completion3 Sep 2021
  4. Study completion3 Sep 2021

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996785
Sponsor's protocol ID
IUSMD-18-33
Status last verified
Nov 2021
First submitted
18 Jun 2019
Last updated
12 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Walking in Urban setting and Walking in nature setting in people with Experimental, run by McGill University at 1 site in Canada.

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 3 inclusion and 4 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 12 Nov 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 Canada. 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?

Change in affect from baseline up to 48 hours post-walk (time frame: Day 1 to Day 3). 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 NCT03996785.

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 12 Nov 2021.

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