Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0

Well-being Clinical Trial

Official title:

Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0: A Well-Being Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257527
• Other study ID #: H16-02273
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: June 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Well-being

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Frank C. Diener Foundation, University of Utah, University of Virginia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, 3, 6 months
Other	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	Baseline, 3, 6 months
Other	Change from Baseline Peer Reports of Satisfaction With Life	Peers will be asked to report on changes to the participant's satisfaction with life	Baseline, 3, 6 months
Other	Change from Baseline Peer Reports of Positive Affect	Peers will be asked to report on changes to the participant's positive affect	Baseline, 3, 6 months
Other	Change from Baseline Peer Reports of Negative Affect	Peers will be asked to report on changes to the participant's negative affect	Baseline, 3, 6 months
Other	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	Baseline, 3, 6 months
Other	Change from Baseline Healthy Behaviors	Behavioral Risk Factor Surveillance System	Baseline, 3, 6 months
Other	Change from Baseline Perceived Stress	Perceived Stress Scale (PSS)	Baseline, 3, 6 months
Other	Change from Baseline Depression	Patient Health Questionnaire-9	Baseline, 3, 6 months
Other	Change from Baseline Self-Esteem	Rosenberg Self-Esteem Scale	Baseline, 3, 6 months
Other	Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness	Need Satisfaction Scale	Baseline, 3, 6 months
Other	Change from Baseline Body Mass Index: BMI	BMI = (Weight in Kilograms / (Height in Meters x Height in Meters))	Baseline, 3, 6 months
Other	Change from Baseline Blood Pressure	Blood pressure is taken twice using a blood pressure cuff and the average will be reported	Baseline, 3, 6 months
Other	Change from Baseline Sleep Quality	The Pittsburgh Sleep Quality Index	Baseline, 3, 6 months
Other	Change from Baseline Alertness	The Stanford Sleepiness Scale	Baseline, 3, 6 months
Other	Objective Change from Baseline in Sleep	Fitbit Sleep data: length, # of times awake	Baseline, 3, 6 months
Primary	Change from Baseline Satisfaction With Life	Satisfaction With Life Scale	Baseline, 3, 6 months
Primary	Change from Baseline in Positive Affect	Scale of Positive and Negative Experience: SPANE	Baseline, 3, 6 months
Primary	Change from Baseline in Negative Affect	Scale of Positive and Negative Experience: SPANE	Baseline, 3, 6 months
Primary	Change from Baseline in Meaning in Life	Meaning in Life Questionnaire	Baseline, 3, 6 months
Primary	Change from Baseline in Thriving	Comprehensive Inventory of Thriving	Baseline, 3, 6 months
Secondary	Change from Baseline in Physical Activity	Step count captured from Fitbits	Baseline, 3, 6 months
Secondary	Change from Baseline in Perceived Social Support	The Social Provisions Scale	Baseline, 3, 6 months
Secondary	Change from Baseline in Relationship Satisfaction	The Revised Dyadic Adjustment Scale	Baseline, 3, 6 months
Secondary	Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making	Automated Neuropsychological Assessment Metrics (ANAM)	Baseline, 3, 6 months
Secondary	Change from Baseline in Implicit Theories of Well-Being		Baseline, 3, 6 months
Secondary	Change from baseline to Empathy	The Toronto Empathy Questionnaire	Baseline, 3, 6 months