HappinessENHANCENCT02782611
Enduring Happiness and Continued Self-Enhancement
A study testing ENHANCE: Enduring Happiness and Continued Self-Enhancement in people with Happiness, run by University of Virginia at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Happiness
- What is being tested?
- ENHANCE: Enduring Happiness and Continued Self-Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants ages 25 to 75
Who cannot join
- Major Depression
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Virginia
Charlottesville, Virginia, 22904-4400
About this study
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.
- Conditions
- Happiness
- Being tested
- ENHANCE: Enduring Happiness and Continued Self-Enhancement
- Keywords
- Happiness, Subjective Well-Being, Psychological Flourishing, Well-Being, Health, Behavioral Change, Life Satisfaction, Affect, Emotion, Goals, Meaning in Life
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENHANCE: Enduring Happiness and Continued Self-EnhancementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: ENHANCE: Enduring Happiness and Continued Self-Enhancement |
| Waiting Group Control | No intervention | The waiting group control will complete the same assessments as the experimental group but without receiving the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Satisfaction With Life
Satisfaction With Life Scale
Measured: Baseline, 3, 6 months
Change from Baseline in Positive Affect
Scale of Positive and Negative Experience: SPANE
Measured: Baseline, 3, 6 months
Change from Baseline in Negative Affect
Scale of Positive and Negative Experience: SPANE
Measured: Baseline, 3, 6 months
Change from Baseline in Meaning in Life
Meaning in Life Questionnaire
Measured: Baseline, 3, 6 months
Change from Baseline in Thriving
Comprehensive Inventory of Thriving
Measured: Baseline, 3, 6 months
Secondary outcomes (13)
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.
Measured: Baseline, 3, 6 months
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,
Measured: Baseline, 3, 6 months
Change from Baseline Peer Reports of Satisfaction With Life
Measured: Baseline, 3, 6 months
Change from Baseline Peer Reports of Positive Affect
Measured: Baseline, 3, 6 months
Change from Baseline Peer Reports of Negative Affect
Measured: Baseline, 3, 6 months
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.
Measured: Baseline, 3, 6 months
Change from Baseline Healthy Behaviors
Behavioral Risk Factor Surveillance System
Measured: Baseline, 3, 6 months
Change from Baseline Perceived Stress
Perceived Stress Scale (PSS)
Measured: Baseline, 3, 6 months
Change from Baseline Depression
Patient Health Questionnaire-9
Measured: Baseline, 3, 6 months
Change from Baseline Self-Esteem
Rosenberg Self-Esteem Scale
Measured: Baseline, 3, 6 months
Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness
Need Satisfaction Scale
Measured: Baseline, 3, 6 months
Change from Baseline Body Mass Index: BMI
Measured: Baseline, 3, 6 months
Change from Baseline Blood Pressure
Measured: Baseline, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HappinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Kostadin Kushlev, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782611
- Sponsor's protocol ID
- 20160044
- Acronym
- ENHANCE
- Status last verified
- Apr 2018
- First submitted
- 7 Apr 2016
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Kushlev K, Heintzelman SJ, Lutes LD, Wirtz D, Kanippayoor JM, Leitner D, Diener E. Does Happiness Improve Health? Evidence From a Randomized Controlled Trial. Psychol Sci. 2020 Jul;31(7):807-821. doi: 10.1177/0956797620919673. Epub 2020 Jun 24.
PubMed 32579432
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enduring Happiness and Continued Self-Enhancement
- ClinicalTrials.gov ID
- NCT02782611
- Acronym / sponsor ID
- ENHANCE / 20160044
- Conditions
- Happiness
- Keywords
- Happiness, Subjective Well-Being, Psychological Flourishing, Well-Being, Health, Behavioral Change, Life Satisfaction, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: ENHANCE: Enduring Happiness and Continued Self-EnhancementENHANCE (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. |
| Waiting Group Control | No intervention | –The waiting group control will complete the same assessments as the experimental group but without receiving the intervention. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants ages 25 to 75
Key exclusion criteria (1 listed)
- Major Depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENHANCE: Enduring Happiness and Continued Self-EnhancementENHANCE 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. | Behavioural | Treatment |
Primary outcome
Change from Baseline Satisfaction With Life
Time frame: Baseline, 3, 6 months
Satisfaction With Life Scale
Change from Baseline in Positive Affect
Time frame: Baseline, 3, 6 months
Scale of Positive and Negative Experience: SPANE
Change from Baseline in Negative Affect
Time frame: Baseline, 3, 6 months
Scale of Positive and Negative Experience: SPANE
Change from Baseline in Meaning in Life
Time frame: Baseline, 3, 6 months
Meaning in Life Questionnaire
Change from Baseline in Thriving
Time frame: Baseline, 3, 6 months
Comprehensive Inventory of Thriving
13 secondary outcomes
Change from Baseline Positive and Negative Memories Generated by Participants
Time frame: Baseline, 3, 6 months
Change from Baseline Peer Reports of Positive Behaviors
Time frame: Baseline, 3, 6 months
Change from Baseline Peer Reports of Satisfaction With Life
Time frame: Baseline, 3, 6 months
Change from Baseline Peer Reports of Positive Affect
Time frame: Baseline, 3, 6 months
Change from Baseline Peer Reports of Negative Affect
Time frame: Baseline, 3, 6 months
Change from Baseline Peer Reports of Negative Behaviors
Time frame: Baseline, 3, 6 months
Change from Baseline Healthy Behaviors
Time frame: Baseline, 3, 6 months
Change from Baseline Perceived Stress
Time frame: Baseline, 3, 6 months
Change from Baseline Depression
Time frame: Baseline, 3, 6 months
Change from Baseline Self-Esteem
Time frame: Baseline, 3, 6 months
Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness
Time frame: Baseline, 3, 6 months
Change from Baseline Body Mass Index: BMI
Time frame: Baseline, 3, 6 months
Change from Baseline Blood Pressure
Time frame: Baseline, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Derived from this study: PubMed 32579432Kushlev K, Heintzelman SJ, Lutes LD, Wirtz D, Kanippayoor JM, Leitner D, Diener E. Does Happiness Improve Health? Evidence From a Randomized Controlled Trial. Psychol Sci. 2020 Jul;31(7):807-821. doi: 10.1177/0956797620919673. Epub 2020 Jun 24.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENHANCE: Enduring Happiness and Continued Self-Enhancement in people with Happiness, run by University of Virginia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Satisfaction With Life (time frame: Baseline, 3, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.