Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0

June 10, 2020 updated by: Lesley Lutes, University of British Columbia

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Kelowna, British Columbia, Canada, V1V1V7
        • University of British Columbia Okanagan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

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
Satisfaction With Life Scale
Baseline, 3, 6 months
Change from Baseline in Positive Affect
Time Frame: Baseline, 3, 6 months
Scale of Positive and Negative Experience: SPANE
Baseline, 3, 6 months
Change from Baseline in Negative Affect
Time Frame: Baseline, 3, 6 months
Scale of Positive and Negative Experience: SPANE
Baseline, 3, 6 months
Change from Baseline in Meaning in Life
Time Frame: Baseline, 3, 6 months
Meaning in Life Questionnaire
Baseline, 3, 6 months
Change from Baseline in Thriving
Time Frame: Baseline, 3, 6 months
Comprehensive Inventory of Thriving
Baseline, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Physical Activity
Time Frame: Baseline, 3, 6 months
Step count captured from Fitbits
Baseline, 3, 6 months
Change from Baseline in Perceived Social Support
Time Frame: Baseline, 3, 6 months
The Social Provisions Scale
Baseline, 3, 6 months
Change from Baseline in Relationship Satisfaction
Time Frame: Baseline, 3, 6 months
The Revised Dyadic Adjustment Scale
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
Automated Neuropsychological Assessment Metrics (ANAM)
Baseline, 3, 6 months
Change from Baseline in Implicit Theories of Well-Being
Time Frame: Baseline, 3, 6 months
Baseline, 3, 6 months
Change from baseline to Empathy
Time Frame: Baseline, 3, 6 months
The Toronto Empathy Questionnaire
Baseline, 3, 6 months

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
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.
Baseline, 3, 6 months
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
Baseline, 3, 6 months
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
Baseline, 3, 6 months
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
Baseline, 3, 6 months
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
Baseline, 3, 6 months
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
Baseline, 3, 6 months
Change from Baseline Healthy Behaviors
Time Frame: Baseline, 3, 6 months
Behavioral Risk Factor Surveillance System
Baseline, 3, 6 months
Change from Baseline Perceived Stress
Time Frame: Baseline, 3, 6 months
Perceived Stress Scale (PSS)
Baseline, 3, 6 months
Change from Baseline Depression
Time Frame: Baseline, 3, 6 months
Patient Health Questionnaire-9
Baseline, 3, 6 months
Change from Baseline Self-Esteem
Time Frame: Baseline, 3, 6 months
Rosenberg Self-Esteem Scale
Baseline, 3, 6 months
Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness
Time Frame: Baseline, 3, 6 months
Need Satisfaction Scale
Baseline, 3, 6 months
Change from Baseline Body Mass Index: BMI
Time Frame: Baseline, 3, 6 months
BMI = (Weight in Kilograms / (Height in Meters x Height in Meters))
Baseline, 3, 6 months
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
Baseline, 3, 6 months
Change from Baseline Sleep Quality
Time Frame: Baseline, 3, 6 months
The Pittsburgh Sleep Quality Index
Baseline, 3, 6 months
Change from Baseline Alertness
Time Frame: Baseline, 3, 6 months
The Stanford Sleepiness Scale
Baseline, 3, 6 months
Objective Change from Baseline in Sleep
Time Frame: Baseline, 3, 6 months
Fitbit Sleep data: length, # of times awake
Baseline, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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