Well-beingNCT03257527
Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0
A study testing ENHANCE group and MBSR group in people with Well-being, run by University of British Columbia at 1 site in Canada.
Trial summary
The study is designed to compare the efficacy of two programs intended to improve happiness and well-being among healthy, community adults between the ages of 25 and 75 years. Participants will complete either an in-person program (ENHANCE) or a mindfulness-based stress reduction (MBSR) self-help program over… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- ENHANCE group and MBSR group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- 10 Apr 2017to 31 Aug 2018
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants in the study will include males and females between the ages of 25 and 75 years. Participants of all racial and ethnic backgrounds will be eligible to participate. Participants of all religious and spiritual orientations will be eligible to participate.
Who cannot join
- Participants will be screened for major psychological disorders, such as anxiety and depression using the Patient Health Questionnaire-9 (PHQ-9. Participants who are screened with a major mental illness (such as severe depression as determined by a cut-off score of 15 or greater on the PHQ-9) will be advised that this study is not designed as a treatment for mental illness (including severe depression), and will be given a list of the appropriate mental health services offered in their community (e.g., Kelowna Mental Health and Substance Use Services).
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V1V7
About this study
Official title: Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0: A Well-Being Program
The study is designed to compare the efficacy of two programs intended to improve happiness and well-being among healthy, community adults between the ages of 25 and 75 years. Participants will complete either an in-person program (ENHANCE) or a mindfulness-based stress reduction (MBSR) self-help program over 3-months. The ENHANCE program will include 12-weekly sessions based on researched principles of happiness. Alternatively, the MBSR self-help guide will teach ways to replace stress-promoting habits. Participants will be asked to complete a series of measures at three points of the study: at the start of the study, the end of the study, and 3-months following the study.
Read the detailed description
In 2011, the United Nations defined happiness as a "fundamental human goal" and invited Member States to pursue measures that enhance the happiness of their citizens. The majority of people across the globe agree that happiness is an important goal. In accordance with this global goal to be happy, the psychological literature abounds with interventions to combat problems that may prevent people from being happy-from obesity to depression and physical pain. However, happiness is not simply the absence of problems. Yet, interventions to help people attain and maintain higher levels of happiness are rare. Accordingly, in a previous study, the investigators designed and evaluated the efficacy of a theoretically-grounded, evidence-based randomized controlled trial for enhancing happiness and well-being. In the present study, it is the goal to assess the efficacy of modifications made to the original program, and compare the program to a self-help comparison group. All participants in the study will complete weekly questionnaires, as well as the same battery of online assessments at baseline, the end of the study, and 3-months following the study. The investigators will be examining if changes seen from baseline to the end of the interventions are maintained through a maintenance intervention in both arms for 3 months following the primary intervention.
It is expect that participants actively completing the in-person ENHANCE program will report greater increase in their overall levels of happiness/well-being at the end of the 12-week program compared to participants in the MBSR self-help group. It is predicted that there will be a downstream effect on happiness for all participants' mental and physical health, cognitive function, social relationships, and other positive outcomes, but that this effect will be greater for participants in the active in-person ENHANCE group. The insights gained from this research could be used in future intervention research towards promoting health, achievement, citizenship, and better relationships.
- Conditions
- Well-being
- Being tested
- ENHANCE group, MBSR group
- Keywords
- Well-being, Comparative Clinical Trial, Positive Psychology Intervention, Mindfulness Based Stress Reduction (MBSR), Group Therapy, Happiness, Bibliotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENHANCE groupBehavioural
The ENHANCE program includes an initial 3-month treatment of 12 weekly sessions (including an introductory session, a final session, and 10 content sessions) followed by a 3-month maintenance phase intervention with bi-weekly sessions. Over the course of the program, participants will learn about 10 evidenced-based principles of happiness and how these principles can be applied effectively in their lives. At the final session, participants will receive feedback outlining the happiness principles and activities that fit them best, and will then be asked to work on creating a plan for integrating those principles into their daily lives.
MBSR groupBehavioural
The MBSR program is based on the self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook". This workbook is authored by Drs. Bob Stahl and Elisha Goldstein - who are both certified MBSR trainers. The workbook is written to help everyday people learn how to replace stress-promoting habits with mindfully-based ones to improve overall well-being. The workbook begins by providing a thorough introduction to the basic tenets of mindfulness, and improving well-being through the use of mindfulness-based skills. The workbook outlines, in detail, several skills-based exercises for practicing mindfulness across different aspects of a person's life. The MBSR group will be provided with a recommended weekly schedule for the initial 3-month treatment and a list of additional resources to be completed over the 3-month maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| ENHANCE group | Experimental | The ENHANCE group is comprised of 12 weekly session to be completed in-person and delivered by trained group facilitators. Receives: Behavioral: ENHANCE group |
| MBSR group | Active comparator | The MBSR group will complete a self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook" over a 12 week period. Receives: Behavioral: MBSR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Satisfaction With Life
Satisfaction With Life Scale
Measured: Baseline, 3, 6 months
Change from Baseline in Positive Affect
Scale of Positive and Negative Experience: SPANE
Measured: Baseline, 3, 6 months
Change from Baseline in Negative Affect
Scale of Positive and Negative Experience: SPANE
Measured: Baseline, 3, 6 months
Change from Baseline in Meaning in Life
Meaning in Life Questionnaire
Measured: Baseline, 3, 6 months
Change from Baseline in Thriving
Comprehensive Inventory of Thriving
Measured: Baseline, 3, 6 months
Secondary outcomes (6)
Change from Baseline in Physical Activity
Step count captured from Fitbits
Measured: Baseline, 3, 6 months
Change from Baseline in Perceived Social Support
The Social Provisions Scale
Measured: Baseline, 3, 6 months
Change from Baseline in Relationship Satisfaction
The Revised Dyadic Adjustment Scale
Measured: Baseline, 3, 6 months
Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making
Automated Neuropsychological Assessment Metrics (ANAM)
Measured: Baseline, 3, 6 months
Change from Baseline in Implicit Theories of Well-Being
Measured: Baseline, 3, 6 months
Change from baseline to Empathy
The Toronto Empathy Questionnaire
Measured: Baseline, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start10 Apr 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Frank C. Diener Foundation, University of Virginia, University of Utah
- Responsible party
- Principal investigator, Lesley Lutes, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257527
- Sponsor's protocol ID
- H16-02273
- Status last verified
- Jun 2020
- First submitted
- 8 Aug 2017
- Last updated
- 11 Jun 2020
- Results posted
- 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 October 2017
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0: A Well-Being Program
- ClinicalTrials.gov ID
- NCT03257527
- Acronym / sponsor ID
- H16-02273
- Conditions
- Well-being
- Keywords
- Well-being, Comparative Clinical Trial, Positive Psychology Intervention, Mindfulness Based Stress Reduction (MBSR), Group Therapy, Happiness, Bibliotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Frank C. Diener Foundation, University of Virginia, University of Utah
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Aug 2017 (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.
The study is designed to compare the efficacy of two programs intended to improve happiness and well-being among healthy, community adults between the ages of 25 and 75 years. Participants will complete either an in-person program (ENHANCE) or a mindfulness-based stress reduction (MBSR) self-help program over 3-months. The ENHANCE program will include 12-weekly sessions based on researched principles of happiness. Alternatively, the MBSR self-help guide will teach ways to replace stress-promoting habits. Participants will be asked to complete a series of measures at three points of the study: at the start of the study, the end of the study, and 3-months following the study.
Detailed description
In 2011, the United Nations defined happiness as a "fundamental human goal" and invited Member States to pursue measures that enhance the happiness of their citizens. The majority of people across the globe agree that happiness is an important goal. In accordance with this global goal to be happy, the psychological literature abounds with interventions to combat problems that may prevent people from being happy-from obesity to depression and physical pain. However, happiness is not simply the absence of problems. Yet, interventions to help people attain and maintain higher levels of happiness are rare. Accordingly, in a previous study, the investigators designed and evaluated the efficacy of a theoretically-grounded, evidence-based randomized controlled trial for enhancing happiness and well-being. In the present study, it is the goal to assess the efficacy of modifications made to the original program, and compare the program to a self-help comparison group. All participants in the study will complete weekly questionnaires, as well as the same battery of online assessments at baseline, the end of the study, and 3-months following the study. The investigators will be examining if changes seen from baseline to the end of the interventions are maintained through a maintenance intervention in both arms for 3 months following the primary intervention.
It is expect that participants actively completing the in-person ENHANCE program will report greater increase in their overall levels of happiness/well-being at the end of the 12-week program compared to participants in the MBSR self-help group. It is predicted that there will be a downstream effect on happiness for all participants' mental and physical health, cognitive function, social relationships, and other positive outcomes, but that this effect will be greater for participants in the active in-person ENHANCE group. The insights gained from this research could be used in future intervention research towards promoting health, achievement, citizenship, and better relationships.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENHANCE group | Experimental | Behavioral: ENHANCE groupThe ENHANCE group is comprised of 12 weekly session to be completed in-person and delivered by trained group facilitators. |
| MBSR group | Active comparator | Behavioral: MBSR groupThe MBSR group will complete a self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook" over a 12 week period. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants in the study will include males and females between the ages of 25 and 75 years. Participants of all racial and ethnic backgrounds will be eligible to participate. Participants of all religious and spiritual orientations will be eligible to participate.
Key exclusion criteria (1 listed)
- Participants will be screened for major psychological disorders, such as anxiety and depression using the Patient Health Questionnaire-9 (PHQ-9. Participants who are screened with a major mental illness (such as severe depression as determined by a cut-off score of 15 or greater on the PHQ-9) will be advised that this study is not designed as a treatment for mental illness (including severe depression), and will be given a list of the appropriate mental health services offered in their community (e.g., Kelowna Mental Health and Substance Use Services).
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 |
|---|---|---|
| ENHANCE groupThe ENHANCE program includes an initial 3-month treatment of 12 weekly sessions (including an introductory session, a final session, and 10 content sessions) followed by a 3-month maintenance phase intervention with bi-weekly sessions. Over the course of the program, participants will learn about 10 evidenced-based principles of happiness and how these principles can be applied effectively in their lives. At the final session, participants will receive feedback outlining the happiness principles and activities that fit them best, and will then be asked to work on creating a plan for integrating those principles into their daily lives. | Behavioural | ENHANCE group |
| MBSR groupThe MBSR program is based on the self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook". This workbook is authored by Drs. Bob Stahl and Elisha Goldstein - who are both certified MBSR trainers. The workbook is written to help everyday people learn how to replace stress-promoting habits with mindfully-based ones to improve overall well-being. The workbook begins by providing a thorough introduction to the basic tenets of mindfulness, and improving well-being through the use of mindfulness-based skills. The workbook outlines, in detail, several skills-based exercises for practicing mindfulness across different aspects of a person's life. The MBSR group will be provided with a recommended weekly schedule for the initial 3-month treatment and a list of additional resources to be completed over the 3-month maintenance phase. | Behavioural | MBSR group |
Primary outcome
Change from Baseline Satisfaction With Life
Time frame: Baseline, 3, 6 months
Satisfaction With Life Scale
Change from Baseline in Positive Affect
Time frame: Baseline, 3, 6 months
Scale of Positive and Negative Experience: SPANE
Change from Baseline in Negative Affect
Time frame: Baseline, 3, 6 months
Scale of Positive and Negative Experience: SPANE
Change from Baseline in Meaning in Life
Time frame: Baseline, 3, 6 months
Meaning in Life Questionnaire
Change from Baseline in Thriving
Time frame: Baseline, 3, 6 months
Comprehensive Inventory of Thriving
6 secondary outcomes
Change from Baseline in Physical Activity
Time frame: Baseline, 3, 6 months
Change from Baseline in Perceived Social Support
Time frame: Baseline, 3, 6 months
Change from Baseline in Relationship Satisfaction
Time frame: Baseline, 3, 6 months
Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making
Time frame: Baseline, 3, 6 months
Change from Baseline in Implicit Theories of Well-Being
Time frame: Baseline, 3, 6 months
Change from baseline to Empathy
Time frame: Baseline, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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 October 2017
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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 ENHANCE group and MBSR group 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Satisfaction With Life (time frame: Baseline, 3, 6 months). The study lists 5 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 11 Jun 2020.