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Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03257527
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Frank C. Diener Foundation
University of Virginia
University of Utah
Information provided by (Responsible Party):
Lesley Lutes, University of British Columbia

Brief 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 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.

Condition or disease Intervention/treatment Phase
Well-being Behavioral: ENHANCE group Behavioral: MBSR group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0: A Well-Being Program
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

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.
Behavioral: ENHANCE group
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.

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.
Behavioral: MBSR group
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.




Primary Outcome Measures :
  1. Change from Baseline Satisfaction With Life [ Time Frame: Baseline, 3, 6 months ]
    Satisfaction With Life Scale

  2. Change from Baseline in Positive Affect [ Time Frame: Baseline, 3, 6 months ]
    Scale of Positive and Negative Experience: SPANE

  3. Change from Baseline in Negative Affect [ Time Frame: Baseline, 3, 6 months ]
    Scale of Positive and Negative Experience: SPANE

  4. Change from Baseline in Meaning in Life [ Time Frame: Baseline, 3, 6 months ]
    Meaning in Life Questionnaire

  5. Change from Baseline in Thriving [ Time Frame: Baseline, 3, 6 months ]
    Comprehensive Inventory of Thriving


Secondary Outcome Measures :
  1. Change from Baseline in Physical Activity [ Time Frame: Baseline, 3, 6 months ]
    Step count captured from Fitbits

  2. Change from Baseline in Perceived Social Support [ Time Frame: Baseline, 3, 6 months ]
    The Social Provisions Scale

  3. Change from Baseline in Relationship Satisfaction [ Time Frame: Baseline, 3, 6 months ]
    The Revised Dyadic Adjustment Scale

  4. Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making [ Time Frame: Baseline, 3, 6 months ]
    Automated Neuropsychological Assessment Metrics (ANAM)

  5. Change from Baseline in Implicit Theories of Well-Being [ Time Frame: Baseline, 3, 6 months ]
  6. Change from baseline to Empathy [ Time Frame: Baseline, 3, 6 months ]
    The Toronto Empathy Questionnaire


Other Outcome Measures:
  1. Change from Baseline Positive and Negative Memories Generated by Participants [ Time Frame: Baseline, 3, 6 months ]
    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.

  2. Change from Baseline Peer Reports of Positive Behaviors [ Time Frame: Baseline, 3, 6 months ]
    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

  3. Change from Baseline Peer Reports of Satisfaction With Life [ Time Frame: Baseline, 3, 6 months ]
    Peers will be asked to report on changes to the participant's satisfaction with life

  4. Change from Baseline Peer Reports of Positive Affect [ Time Frame: Baseline, 3, 6 months ]
    Peers will be asked to report on changes to the participant's positive affect

  5. Change from Baseline Peer Reports of Negative Affect [ Time Frame: Baseline, 3, 6 months ]
    Peers will be asked to report on changes to the participant's negative affect

  6. Change from Baseline Peer Reports of Negative Behaviors [ Time Frame: Baseline, 3, 6 months ]
    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

  7. Change from Baseline Healthy Behaviors [ Time Frame: Baseline, 3, 6 months ]
    Behavioral Risk Factor Surveillance System

  8. Change from Baseline Perceived Stress [ Time Frame: Baseline, 3, 6 months ]
    Perceived Stress Scale (PSS)

  9. Change from Baseline Depression [ Time Frame: Baseline, 3, 6 months ]
    Patient Health Questionnaire-9

  10. Change from Baseline Self-Esteem [ Time Frame: Baseline, 3, 6 months ]
    Rosenberg Self-Esteem Scale

  11. Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness [ Time Frame: Baseline, 3, 6 months ]
    Need Satisfaction Scale

  12. Change from Baseline Body Mass Index: BMI [ Time Frame: Baseline, 3, 6 months ]
    BMI = (Weight in Kilograms / (Height in Meters x Height in Meters))

  13. Change from Baseline Blood Pressure [ Time Frame: Baseline, 3, 6 months ]
    Blood pressure is taken twice using a blood pressure cuff and the average will be reported

  14. Change from Baseline Sleep Quality [ Time Frame: Baseline, 3, 6 months ]
    The Pittsburgh Sleep Quality Index

  15. Change from Baseline Alertness [ Time Frame: Baseline, 3, 6 months ]
    The Stanford Sleepiness Scale

  16. Objective Change from Baseline in Sleep [ Time Frame: Baseline, 3, 6 months ]
    Fitbit Sleep data: length, # of times awake



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257527


Locations
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Canada, British Columbia
University of British Columbia Okanagan
Kelowna, British Columbia, Canada, V1V1V7
Sponsors and Collaborators
University of British Columbia
Frank C. Diener Foundation
University of Virginia
University of Utah
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Responsible Party: Lesley Lutes, Associate Professor, Director of Clinical Training, University of British Columbia
ClinicalTrials.gov Identifier: NCT03257527    
Other Study ID Numbers: H16-02273
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 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 October 2017

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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:
Well-being
Comparative Clinical Trial
Positive Psychology Intervention
Mindfulness Based Stress Reduction (MBSR)
Group Therapy
Happiness
Bibliotherapy