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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04602832
Other study ID # University of British Columbia
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 14, 2020
Est. completion date December 2020

Study information

Verified date October 2020
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study is designed as a 12-week, two-armed, randomized controlled trail to assess the efficacy of a COVID-19-modified version of the Enduring Happiness and Continued Self-Enhancement (ENHANCE) program. The ENHANCE program represents a 12-week multi-construct, evidenced-based intervention for improving overall happiness and subjective well-being. The ENHANCE program was modified specifically to address the known health and well-being challenges of the COVID-19 pandemic. Eligible participants will be randomized into either the ENHANCE program or Wait-List Control (WLC) group. ENHANCE participants will be introduced to 10 evidenced-based principles that have been shown to improve health and well-being outcomes. Participants will be further guided to systematically practice these principles in their daily lives using a small-changes approach. WLC participants will be asked to continue life a usual, and provided some additional health and well-being resources that can be accessed online to support current, ongoing distress, if needed. Participants will be asked to complete an online survey about their emotional, social, and physical well-being at baseline (or at the start of the study), midway (or 6-weeks into the study), and at post-assessment (or at the end of the study period). At the end of the study period, all control participants will also be offered the full ENHANCE program. Investigators expect that participants receiving the ENHANCE program will show improvements across all negative (e.g., depression, anxiety) and positive (e.g., life satisfaction, quality of life) variables from baseline to post-study. Investigators further expect there to be immediate positive health and economic outcomes linked to active participation in the ENHANCE program (versus the WLC group). Investigators believe the impacts of this research will include (a) mitigating the risk of a severe onset of mental health problems related to anxiety, depression, post-traumatic stress, and suicide, (b) increasing positive mental health and well-being, and (c) increasing physical health in participants across time.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19
ENHANCE is a 12-session program designed to help improve subjective well-being, especially through the challenges of a pandemic. The ENHANCE program introduces and teaches people about the evidence-based principles and skills that have been shown across decades of research to improve overall health and well-being.

Locations

Country Name City State
Canada University of British Columbia Kelowna British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia University of Utah, University of Virginia

Country where clinical trial is conducted

Canada, 

Outcome

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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