NCT03996785

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

June 18, 2019

Last Update Submit

November 5, 2021

Conditions

Keywords

Clinical depressionStressGroup-walkingWalking condition (nature vs urban)

Outcome Measures

Primary Outcomes (1)

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

    Positive and Negative Affect Schedule (PANAS)

    Day 1 to Day 3

Secondary Outcomes (5)

  • Change in Executive Functions

    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

    Day 1

  • Change in depressive symptoms

    Day 1 to Day 2

  • Change in rumination

    Day 1

  • Change in irritability

    Day 1 to Day 3

Study Arms (2)

Urban

ACTIVE COMPARATOR

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

Nature

EXPERIMENTAL

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

Interventions

Walking for 60 minutes as described above

Urban

Walking for 60 minutes as described above

Nature

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Walking

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Marie-Claude Geoffroy, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were unaware as to whether they were assigned to an urban or nature walking condition
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 25, 2019

Study Start

June 18, 2019

Primary Completion

September 3, 2021

Study Completion

September 3, 2021

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations