Well-Being Clinical Trial
— EN-COVID-19Official title:
A Randomized Controlled Trial of an Online Well-Being Intervention (The ENHANCE Program) for Improving Individuals Health and Well-Being During the COVID-19 Pandemic
Verified date | October 2020 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a randomized controlled trial of an online, evidenced-based intervention (the ENHANCE program) that was modified to address the health and well-being challenges of COVID-19. Eligible participants will be randomized into the ENHANCE or Wait-List Control group over a 12-week period. ENHANCE participants will be introduced, and asked to practice, 10 evidenced-based principles and skills of happiness and well-being. Participants will complete an online survey about their health and well-being at baseline, midway (or 6 weeks), post-assessment (or at the end of the 12-week study), and 3-months following the end of the study.
Status | Enrolling by invitation |
Enrollment | 350 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Individuals who are fluent in English and are 19 years or older. Exclusion Criteria: - N/A |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Kelowna | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | University of Utah, University of Virginia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Beck Depression Inventory - II (BDI-II) | Change from baseline mood | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Primary | Satisfaction With Life Scale (SWLS) | Change from baseline satisfaction with life | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Primary | Generalized Anxiety Disorder - 7 (GAD-7) | Change from baseline anxiety | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Primary | Patient Health Questionnaire (PHQ-9) | Change from baseline mood | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Primary | Perceived Stress Scale (PSS) | Change from baseline stress | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Primary | Positive and Negative Affect Scale (PANAS) | Change from baseline affect | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Primary | Health Anxiety Inventory Short-Form (HAI-SF) | Change from baseline anxiety | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | World Health Organization Quality of Life (WHOQOL - BREF) | Change from baseline quality of life | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | Meaning In Life Questionnaire (MLQ) | Change from baseline meaning in life | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | Sleep Disorder Questionnaire (SDQ) | Change from baseline sleep quality | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | Measure of Attachment Qualities (MAQ) | Change from baseline attachment | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale) | Change from baseline loneliness | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | Insomnia Severity Index (ISI) | Change from baseline sleep quality | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | Paffenbarger Physical Activity Questionnaire (PPAQ) | Change from baseline physical activity | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) | Change from baseline trauma-related distress | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) | |
Secondary | European Quality of Life Group - 5 Dimensions - 5 Levels (EQ-5D-5L) | Change from baseline quality of life | Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) |
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