- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04602832
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals who are fluent in English and are 19 years or older.
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ENHANCE Treatment Group
The 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.
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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.
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NO_INTERVENTION: Wait-List Control Group
Over 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory - II (BDI-II)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline mood
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Satisfaction With Life Scale (SWLS)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline satisfaction with life
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline anxiety
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline mood
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Perceived Stress Scale (PSS)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline stress
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Positive and Negative Affect Scale (PANAS)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline affect
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Health Anxiety Inventory Short-Form (HAI-SF)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline anxiety
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
World Health Organization Quality of Life (WHOQOL - BREF)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline quality of life
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Meaning In Life Questionnaire (MLQ)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline meaning in life
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Sleep Disorder Questionnaire (SDQ)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline sleep quality
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Measure of Attachment Qualities (MAQ)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline attachment
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline loneliness
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Insomnia Severity Index (ISI)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline sleep quality
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Paffenbarger Physical Activity Questionnaire (PPAQ)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline physical activity
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline trauma-related distress
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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European Quality of Life Group - 5 Dimensions - 5 Levels (EQ-5D-5L)
Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Change from baseline quality of life
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Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- University of British Columbia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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