Stress Clinical Trial
Official title:
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
Verified date | May 2023 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Douglas Mental Health University Institute | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University |
Canada,
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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