Well-BeingEN-COVID-19NCT04602832
Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19
A study testing Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 in people with Well-Being, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being
- What is being tested?
- Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are fluent in English and are 19 years or older.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Well-Being
- Being tested
- Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19
- Keywords
- Health and Well-Being, Positive Psychology Intervention, Online Bibliotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19Other
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.
| Study group | Role | What they receive |
|---|---|---|
| ENHANCE Treatment Group | Experimental | 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. Receives: Other: Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 |
| Wait-List Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory - II (BDI-II)
Change from baseline mood
Measured: 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
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Generalized Anxiety Disorder - 7 (GAD-7)
Change from baseline anxiety
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Patient Health Questionnaire (PHQ-9)
Change from baseline mood
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Perceived Stress Scale (PSS)
Change from baseline stress
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Positive and Negative Affect Scale (PANAS)
Change from baseline affect
Measured: 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
Measured: 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)
Change from baseline quality of life
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Meaning In Life Questionnaire (MLQ)
Change from baseline meaning in life
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Sleep Disorder Questionnaire (SDQ)
Change from baseline sleep quality
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Measure of Attachment Qualities (MAQ)
Change from baseline attachment
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale)
Change from baseline loneliness
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Insomnia Severity Index (ISI)
Change from baseline sleep quality
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Paffenbarger Physical Activity Questionnaire (PPAQ)
Change from baseline physical activity
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5)
Change from baseline trauma-related distress
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
European Quality of Life Group - 5 Dimensions - 5 Levels (EQ-5D-5L)
Change from baseline quality of life
Measured: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start14 Oct 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-BeingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Utah
- Responsible party
- Principal investigator, Lesley Lutes, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602832
- Sponsor's protocol ID
- University of British Columbia
- Acronym
- EN-COVID-19
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04602832
- Acronym / sponsor ID
- EN-COVID-19 / University of British Columbia
- Conditions
- Well-Being
- Keywords
- Health and Well-Being, Positive Psychology Intervention, Online Bibliotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Virginia, University of Utah
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENHANCE Treatment Group | Experimental | Other: Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19The 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 intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who are fluent in English and are 19 years or older.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19ENHANCE 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. | Other | ENHANCE Treatment Group |
Primary outcome
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
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
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
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
Perceived Stress Scale (PSS)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline stress
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
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
9 secondary outcomes
World Health Organization Quality of Life (WHOQOL - BREF)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Meaning In Life Questionnaire (MLQ)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Sleep Disorder Questionnaire (SDQ)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Measure of Attachment Qualities (MAQ)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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)
Insomnia Severity Index (ISI)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Paffenbarger Physical Activity Questionnaire (PPAQ)
Time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 in people with Well-Being, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory - II (BDI-II) (time frame: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.