Clinical trial NCT04602832: Enduring Happiness and Continued Self-Enhancement (ENHANCE) for 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Well-Being
Keywords: Health and Well-Being
Positive Psychology Intervention
Online Bibliotherapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: University of Utah
First posted: 2020-10-26
Enrollment: 350
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Individuals who are fluent in English and are 19 years or older.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Health Anxiety Inventory Short-Form (HAI-SF)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Secondary outcomes:
measure: World Health Organization Quality of Life (WHOQOL - BREF)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Meaning In Life Questionnaire (MLQ)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Sleep Disorder Questionnaire (SDQ)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Measure of Attachment Qualities (MAQ)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: Paffenbarger Physical Activity Questionnaire (PPAQ)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
measure: European Quality of Life Group - 5 Dimensions - 5 Levels (EQ-5D-5L)
timeFrame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References: