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CompletedNCT03257527Updated Jun 11, 2020

Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0

An interventional study of ENHANCE group and MBSR group in Well-being, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by University of British Columbia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Well-being

Keywords

  • Well-being
  • Comparative Clinical Trial
  • Positive Psychology Intervention
  • Mindfulness Based Stress Reduction (MBSR)
  • Group Therapy
  • Happiness
  • Bibliotherapy
03

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralENHANCE 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.

  • BehavioralMBSR 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.

05

What researchers measure

Primary outcomes

  1. Change from Baseline Satisfaction With Life

    Satisfaction With Life Scale

    Time frame: Baseline, 3, 6 months

  2. Change from Baseline in Positive Affect

    Scale of Positive and Negative Experience: SPANE

    Time frame: Baseline, 3, 6 months

  3. Change from Baseline in Negative Affect

    Scale of Positive and Negative Experience: SPANE

    Time frame: Baseline, 3, 6 months

  4. Change from Baseline in Meaning in Life

    Meaning in Life Questionnaire

    Time frame: Baseline, 3, 6 months

  5. Change from Baseline in Thriving

    Comprehensive Inventory of Thriving

    Time frame: Baseline, 3, 6 months

Secondary outcomes

  1. Change from Baseline in Physical Activity

    Step count captured from Fitbits

    Time frame: Baseline, 3, 6 months

  2. Change from Baseline in Perceived Social Support

    The Social Provisions Scale

    Time frame: Baseline, 3, 6 months

  3. Change from Baseline in Relationship Satisfaction

    The Revised Dyadic Adjustment Scale

    Time frame: Baseline, 3, 6 months

  4. Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making

    Automated Neuropsychological Assessment Metrics (ANAM)

    Time frame: Baseline, 3, 6 months

  5. Change from Baseline in Implicit Theories of Well-Being

    Time frame: Baseline, 3, 6 months

  6. Change from baseline to Empathy

    The Toronto Empathy Questionnaire

    Time frame: Baseline, 3, 6 months

Other outcomes

  1. Change from Baseline Positive and Negative Memories Generated by Participants

    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.

    Time frame: Baseline, 3, 6 months

  2. Change from Baseline Peer Reports of Positive Behaviors

    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

    Time frame: Baseline, 3, 6 months

  3. Change from Baseline Peer Reports of Satisfaction With Life

    Peers will be asked to report on changes to the participant's satisfaction with life

    Time frame: Baseline, 3, 6 months

  4. Change from Baseline Peer Reports of Positive Affect

    Peers will be asked to report on changes to the participant's positive affect

    Time frame: Baseline, 3, 6 months

  5. Change from Baseline Peer Reports of Negative Affect

    Peers will be asked to report on changes to the participant's negative affect

    Time frame: Baseline, 3, 6 months

  6. Change from Baseline Peer Reports of Negative Behaviors

    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

    Time frame: Baseline, 3, 6 months

  7. Change from Baseline Healthy Behaviors

    Behavioral Risk Factor Surveillance System

    Time frame: Baseline, 3, 6 months

  8. Change from Baseline Perceived Stress

    Perceived Stress Scale (PSS)

    Time frame: Baseline, 3, 6 months

  9. Change from Baseline Depression

    Patient Health Questionnaire-9

    Time frame: Baseline, 3, 6 months

  10. Change from Baseline Self-Esteem

    Rosenberg Self-Esteem Scale

    Time frame: Baseline, 3, 6 months

  11. Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness

    Need Satisfaction Scale

    Time frame: Baseline, 3, 6 months

  12. Change from Baseline Body Mass Index: BMI

    BMI = (Weight in Kilograms / (Height in Meters x Height in Meters))

    Time frame: Baseline, 3, 6 months

  13. Change from Baseline Blood Pressure

    Blood pressure is taken twice using a blood pressure cuff and the average will be reported

    Time frame: Baseline, 3, 6 months

  14. Change from Baseline Sleep Quality

    The Pittsburgh Sleep Quality Index

    Time frame: Baseline, 3, 6 months

  15. Change from Baseline Alertness

    The Stanford Sleepiness Scale

    Time frame: Baseline, 3, 6 months

  16. Objective Change from Baseline in Sleep

    Fitbit Sleep data: length, # of times awake

    Time frame: Baseline, 3, 6 months

06

Study locations

1 site
  • University of British Columbia Okanagan
    Kelowna, British Columbia V1V1V7, Canada
07

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03257527
Lead sponsor
University of British Columbia
Collaborators
Frank C. Diener Foundation, University of Virginia, University of Utah
Responsible party
Lesley Lutes (Associate Professor, Director of Clinical Training, University of British Columbia) — Principal investigator
First posted
Aug 22, 2017
Start date
Apr 10, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Jun 11, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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