Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19

Well-Being Clinical Trial

— EN-COVID-19  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04602832
• Other study ID #: University of British Columbia
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Well-Being

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)