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

• ClinicalTrials.gov Identifier: NCT04602832
• Recruitment Status: Enrolling by invitation
• First Posted: October 26, 2020
• Last Update Posted: November 4, 2020
• Sponsor: University of British Columbia
• Collaborators: University of Virginia; University of Utah
• Information provided by (Responsible Party): Lesley Lutes, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Well-Being	Other: Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: October 14, 2020
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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.	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.
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.

Outcome Measures

Primary Outcome Measures :

1. Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline mood
2. Satisfaction With Life Scale (SWLS) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline satisfaction with life
3. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline anxiety
4. Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline mood
5. Perceived Stress Scale (PSS) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline stress
6. Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline affect
7. Health Anxiety Inventory Short-Form (HAI-SF) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline anxiety

Secondary Outcome Measures :

1. World Health Organization Quality of Life (WHOQOL - BREF) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline quality of life
2. Meaning In Life Questionnaire (MLQ) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline meaning in life
3. Sleep Disorder Questionnaire (SDQ) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline sleep quality
4. Measure of Attachment Qualities (MAQ) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline attachment
5. 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) ]
   Change from baseline loneliness
6. Insomnia Severity Index (ISI) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline sleep quality
7. Paffenbarger Physical Activity Questionnaire (PPAQ) [ Time Frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months) ]
   Change from baseline physical activity
8. 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) ]
   Change from baseline trauma-related distress
9. 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) ]
   Change from baseline quality of life

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

Canada, British Columbia

University of British Columbia

Kelowna, British Columbia, Canada, V1V 1V7

Sponsors and Collaborators

University of British Columbia

University of Virginia

University of Utah

More Information

• Responsible Party: Lesley Lutes, Dr. Lesley Lutes, R.Psych., University of British Columbia
• ClinicalTrials.gov Identifier: NCT04602832
• Other Study ID Numbers: University of British Columbia
• First Posted: October 26, 2020
• Last Update Posted: November 4, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: We are currently consulting with others on the grant team regarding our long-term data plan and will update with our final data sharing plan in January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lesley Lutes, University of British Columbia:

Health and Well-Being; Positive Psychology Intervention; Online Bibliotherapy