- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257527
Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0
Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0: A Well-Being Program
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1V1V7
- University of British Columbia Okanagan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ENHANCE group
The ENHANCE group is comprised of 12 weekly session to be completed in-person and delivered by trained group facilitators.
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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.
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Active Comparator: MBSR group
The MBSR group will complete a self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook" over a 12 week period.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Satisfaction With Life
Time Frame: Baseline, 3, 6 months
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Satisfaction With Life Scale
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Baseline, 3, 6 months
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Change from Baseline in Positive Affect
Time Frame: Baseline, 3, 6 months
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Scale of Positive and Negative Experience: SPANE
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Baseline, 3, 6 months
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Change from Baseline in Negative Affect
Time Frame: Baseline, 3, 6 months
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Scale of Positive and Negative Experience: SPANE
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Baseline, 3, 6 months
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Change from Baseline in Meaning in Life
Time Frame: Baseline, 3, 6 months
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Meaning in Life Questionnaire
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Baseline, 3, 6 months
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Change from Baseline in Thriving
Time Frame: Baseline, 3, 6 months
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Comprehensive Inventory of Thriving
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Baseline, 3, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Physical Activity
Time Frame: Baseline, 3, 6 months
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Step count captured from Fitbits
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Baseline, 3, 6 months
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Change from Baseline in Perceived Social Support
Time Frame: Baseline, 3, 6 months
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The Social Provisions Scale
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Baseline, 3, 6 months
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Change from Baseline in Relationship Satisfaction
Time Frame: Baseline, 3, 6 months
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The Revised Dyadic Adjustment Scale
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Baseline, 3, 6 months
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Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making
Time Frame: Baseline, 3, 6 months
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Automated Neuropsychological Assessment Metrics (ANAM)
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Baseline, 3, 6 months
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Change from Baseline in Implicit Theories of Well-Being
Time Frame: Baseline, 3, 6 months
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Baseline, 3, 6 months
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Change from baseline to Empathy
Time Frame: Baseline, 3, 6 months
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The Toronto Empathy Questionnaire
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Baseline, 3, 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Positive and Negative Memories Generated by Participants
Time Frame: Baseline, 3, 6 months
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In this task, participants list as many positive (and then negative) life events and then as many negative life events as they can in three minutes.
Relative quantities of positive to negative life events that are listed demonstrate accessibility of positive and negative memories, which is an indicator of Subjective Well-Being.
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Baseline, 3, 6 months
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Change from Baseline Peer Reports of Positive Behaviors
Time Frame: Baseline, 3, 6 months
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Peers will be asked to evaluate the participant on how frequently they engaged in a series of affect-related displays over the past week: smiling, laughing
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Baseline, 3, 6 months
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Change from Baseline Peer Reports of Satisfaction With Life
Time Frame: Baseline, 3, 6 months
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Peers will be asked to report on changes to the participant's satisfaction with life
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Baseline, 3, 6 months
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Change from Baseline Peer Reports of Positive Affect
Time Frame: Baseline, 3, 6 months
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Peers will be asked to report on changes to the participant's positive affect
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Baseline, 3, 6 months
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Change from Baseline Peer Reports of Negative Affect
Time Frame: Baseline, 3, 6 months
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Peers will be asked to report on changes to the participant's negative affect
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Baseline, 3, 6 months
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Change from Baseline Peer Reports of Negative Behaviors
Time Frame: Baseline, 3, 6 months
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Peers will be asked to evaluate the participant on how frequently they engaged in a series of affect-related displays over the past week: crying, frowning, complaining, and criticizing
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Baseline, 3, 6 months
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Change from Baseline Healthy Behaviors
Time Frame: Baseline, 3, 6 months
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Behavioral Risk Factor Surveillance System
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Baseline, 3, 6 months
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Change from Baseline Perceived Stress
Time Frame: Baseline, 3, 6 months
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Perceived Stress Scale (PSS)
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Baseline, 3, 6 months
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Change from Baseline Depression
Time Frame: Baseline, 3, 6 months
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Patient Health Questionnaire-9
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Baseline, 3, 6 months
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Change from Baseline Self-Esteem
Time Frame: Baseline, 3, 6 months
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Rosenberg Self-Esteem Scale
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Baseline, 3, 6 months
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Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness
Time Frame: Baseline, 3, 6 months
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Need Satisfaction Scale
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Baseline, 3, 6 months
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Change from Baseline Body Mass Index: BMI
Time Frame: Baseline, 3, 6 months
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BMI = (Weight in Kilograms / (Height in Meters x Height in Meters))
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Baseline, 3, 6 months
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Change from Baseline Blood Pressure
Time Frame: Baseline, 3, 6 months
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Blood pressure is taken twice using a blood pressure cuff and the average will be reported
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Baseline, 3, 6 months
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Change from Baseline Sleep Quality
Time Frame: Baseline, 3, 6 months
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The Pittsburgh Sleep Quality Index
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Baseline, 3, 6 months
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Change from Baseline Alertness
Time Frame: Baseline, 3, 6 months
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The Stanford Sleepiness Scale
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Baseline, 3, 6 months
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Objective Change from Baseline in Sleep
Time Frame: Baseline, 3, 6 months
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Fitbit Sleep data: length, # of times awake
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Baseline, 3, 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- H16-02273
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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