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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05889078
Other study ID # IUSMD-18-33 Phase 2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date May 30, 2023

Study information

Verified date May 2023
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomized controlled trial is to examine the effects of a walking intervention (3 walks per week for a period of 4 weeks) in a nature vs. urban setting on the wellbeing of young adult postsecondary students. We will examine changes in positive and negative affect for participants assigned to the nature condition vs those assigned to the urban condition (primary outcome). We will also examine changes in reported depression and anxiety symptoms, perceived stress levels, sleep quality, mindfulness and wellbeing (secondary outcome).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - aged 18-25 years - speaks English - had working smartphone that can track walk routes using a smartphone application Exclusion Criteria: - inability to walk for 45 minutes due to serious medical reasons (eg surgery) - heart condition

Study Design


Intervention

Behavioral:
A 4-week walking intervention
Participants will walk along a predetermined route 3 times per week for a period of 4 weeks, answering a pre- and post-intervention questionnaire as well as weekly questionnaires measuring their affect and other variables related to wellbeing. Participants will be randomly assigned to one of two conditions (nature vs urban setting), determining whether the predetermined route they will walk is in a nature or urban setting.

Locations

Country Name City State
Canada Douglas Mental Health University Institute Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in baseline positive affect at 4 weeks Measured by the Positive and Negative Affect Schedule. Total scores range from 10-50 for positive affect, with higher scores indicating higher levels of positive affect (a better outcome). 4 weeks (1x per week for 4 weeks)
Primary Change in baseline negative affect at 4 weeks Measured by the Positive and Negative Affect Schedule. Total scores range from 10-50 for negative affect, with higher scores indicating higher levels of negative affect (a worse outcome). 4 weeks (1x per week for 4 weeks)
Secondary Change in baseline depression symptoms at 5 weeks Measured by the Patient Health Questionnaire-9 Items (PHQ-9), with total scores ranging from 0-27, with higher scores indicating more depressive symptoms (a worse outcome). 5 weeks (1 week following completion of study intervention)
Secondary Change in baseline anxiety symptoms at 5 weeks Measured by the General Anxiety Disorder-7 (GAD-7), with total scores ranging from 0-21, with higher scores indicating greater severity in anxiety symptoms (a worse outcome). 5 weeks (1 week following completion of study intervention)
Secondary Change in baseline perceived stress levels at 5 weeks Measured by the Perceived Stress Scale (PSS), with total scores ranging from 0 to 40 with higher scores indicating higher perceived stress (a worse outcome). 5 weeks (1 week following completion of study intervention)
Secondary Change in baseline sleep quality at 5 weeks Measured by the Pittsburgh Sleep Quality Index (PSQI), with total scores ranging from 0 to 21 with higher scores indicating worse sleep quality (a worse outcome). 5 weeks (1 week following completion of study intervention)
Secondary Change in baseline mindfulness at 5 weeks Measured by the Five Facets of Mindfulness Questionnaire (FFMQ). Each item is rated from 1 = rarely true to 5 = always true. Results comprise a total average score and 5 subscale scores. Average scores are calculated by summing the responses and dividing by the number of items. Higher scores indicate higher levels of mindfulness (a better outcome). 5 weeks (1 week following completion of study intervention)
Secondary Change in baseline levels of wellbeing at 5 weeks Measured by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), with scores ranging from 14 to 70. Higher scores indicate greater positive mental wellbeing (a better outcome). 5 weeks (1 week following completion of study intervention)
Secondary Change in baseline non-suicidal self-injury at 5 weeks We assessed Non-Suicidal Self-Injury using a question previously used with same-aged participants in the Québec Longitudinal Study of Child Development: "Sometimes, some people hurt themselves intentionally, even when they don't have the intention to kill themselves. Over the past two weeks, have you harmed yourself deliberately, without the intention to kill yourself?" rated from 1 = never to 4 = very often. High scores indicate greater frequency of non-suicidal self-injury (a worse outcome). 5 weeks (1 week following completion of study intervention)
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