- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02782611
Enduring Happiness and Continued Self-Enhancement (ENHANCE)
April 11, 2018 updated by: Kostadin Kushlev, University of Virginia
Over the past several decades, a new science of subjective well-being has produced insights into the factors that make people happy-from cultivating strong relationships to pursuing the right goals.
Drawing on these empirical findings, the investigators created a comprehensive 12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement.
The investigators multimodal program is designed to teach people essential skills in order to produce sustainable changes in behavior and, as a result, long-lasting increases in happiness.
To test the effectiveness of ENHANCE, the investigators designed a six-month randomized clinical trial.
Participants will be assigned to an active treatment group or a waiting group control.
They will complete baseline assessments, and follow-up assessment at three and six months after the start of the intervention.
These assessments will contain measures of subjective well-being and objective measures of health, as well as a variety of psychological mediators (e.g., psychological needs) and moderators (e.g.
personality).
The investigators will thus be able to explore not only whether ENHANCE works to improve well-being, but also why and how ENHANCE works.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
154
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
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British Columbia
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Kelowna, British Columbia, Canada, V1V1V7
- University of British Columbia
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Virginia
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Charlottesville, Virginia, United States, 22904-4400
- University of Virginia
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Participants ages 25 to 75
Exclusion Criteria:
• Major Depression
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Treatment
ENHANCE (Enduring Happiness and Continued Self-Enhancement) is a 12-week program that includes an introductory session, 10 weekly sessions focusing on different happiness principles, and a final session focusing on integrating aspects of the program and continuing to practice these principles moving forward.
Through completing this program, participants will gain an education on a wide-range of happiness principles and an arsenal of strategies for developing happiness boosting habits and skills.
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ENHANCE is a skill-based intervention to teach people a wide variety of strategies that have been shown to boost happiness.
Each session of ENHANCE follows a similar format targeted to address three central goals.
First, in each session, participants will complete an active learning module designed to educate participants about one of the ten overarching topics featured in this program (e.g., goals, close relationships).
Next, participants will engage in activities that put these principles into practice.
Finally, this program is designed to encourage a skill-building mindset by helping participants develop habits to integrate these principles into maintained activity in their daily lives moving forward.
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No Intervention: Waiting Group Control
The waiting group control will complete the same assessments as the experimental group but without receiving the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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 |
|---|---|---|
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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 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 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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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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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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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 Body Mass Index: BMI
Time Frame: Baseline, 3, 6 months
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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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Baseline, 3, 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
April 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
April 7, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (Estimate)
May 25, 2016
Study Record Updates
Last Update Posted (Actual)
April 13, 2018
Last Update Submitted That Met QC Criteria
April 11, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20160044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.