Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19
EN-COVID-19
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
1 other identifier
interventional
350
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2020
CompletedFirst Submitted
Initial submission to the registry
October 23, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 4, 2020
October 1, 2020
2 months
October 23, 2020
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Beck Depression Inventory - II (BDI-II)
Change from baseline mood
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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)
Generalized Anxiety Disorder - 7 (GAD-7)
Change from baseline anxiety
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Patient Health Questionnaire (PHQ-9)
Change from baseline mood
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Perceived Stress Scale (PSS)
Change from baseline stress
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Positive and Negative Affect Scale (PANAS)
Change from baseline affect
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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 Outcomes (9)
World Health Organization Quality of Life (WHOQOL - BREF)
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Meaning In Life Questionnaire (MLQ)
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Sleep Disorder Questionnaire (SDQ)
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Measure of Attachment Qualities (MAQ)
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale)
Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
- +4 more secondary outcomes
Study Arms (2)
ENHANCE Treatment Group
EXPERIMENTALThe ENHANCE program was tailored to address the current health and well-being challenges faced by individuals living in the COVID-19 pandemic. The contents of each week will focus on a new evidenced-based principle that has been shown in research to decrease negative thinking and emotions, as well as increase positive thinking, emotions, and overall physical and mental health and well-being. Each week participants will focus on the skills and methods of implementing happiness and well-being into their daily routine.
Wait-List Control Group
NO INTERVENTIONOver the course of the study, participants will be asked to refrain from accessing the ENHANCE program materials to ensure the integrity of the research design. At the end of the study duration, participants will receive the full ENHANCE program.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Individuals who are fluent in English and are 19 years or older.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- University of Virginiacollaborator
- University of Utahcollaborator
Study Sites (1)
University of British Columbia
Kelowna, British Columbia, V1V 1V7, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Lesley Lutes, R.Psych.
Study Record Dates
First Submitted
October 23, 2020
First Posted
October 26, 2020
Study Start
October 14, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 4, 2020
Record last verified: 2020-10