Mental Health Wellness 1 Clinical Trial
Official title:
Healthier Together Mood Booster Challenge
NCT number | NCT05772650 |
Other study ID # | CLIN1903 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 6, 2023 |
Est. completion date | June 30, 2023 |
Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 30, 2023 |
Est. primary completion date | April 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Affiliated with McGill University or family member Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Physical Activity Levels | 8 week program to create healthy habits of incorporating increased physical activity in daily life.
Self-reported physical activity levels using the International Physical Activity Questionnaire (IPAQ) (weekly metabolic equivalents (METs); using an estimate of 4 METs/ min moderate exercise and 8 METs/ min vigorous exercise) |
Feb 20 - April 16, 2023 | |
Primary | Adherence to Program | 8 Week program to help change behaviour for healthy habit creation. Adherence will be measured as the number of days tracking physical activity levels and answering the behaviour change questions.
Less than 7 days = very poor adherence 7-21 days = poor adherence 22-42 days = moderate adherence 43-49 days = good adherence Greater than 49 days = excellent adherence |
Feb 20 - April 16, 2023 | |
Primary | Improvement in Stress | The following methodology will be used to measure the above metric:
- Stress score - Perceived Stress Scale. 10 questions; Total score from 0 to 40; =18 high stress (1 standard deviation above the mean) |
Feb 20 - April 16, 2023 | |
Primary | Improvement in Sleep | The following methodology will be used to measure the above metric:
- Sleep score - Insomnia Severity Index. 7 questions; Total score from 0 to 28; = 8 subthreshold insomnia |
Feb 20 - April 16, 2023 | |
Primary | Improvement in Mood | The following methodology will be used to measure the above metric:
- Depression score - Centre for Epidemiological Studies - Depression questionnaire 20 questions; Total score 0-40; =16 subthreshold depressive symptoms |
Feb 20 - April 16, 2023 | |
Primary | Improvement in Burnout | The following methodology will be used to measure the above metric:
- Burnout - Oldenburg burnout assessment. <2.89 no or little sign of burnout; 2.89 to 3.51 may be at risk of burnout; >3.51 at very high risk of burnout |
Feb 20 - April 16, 2023 |
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