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Enduring Happiness and Continued Self-Enhancement (ENHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782611
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Kostadin Kushlev, University of Virginia

Tracking Information
First Submitted Date  ICMJE April 7, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date April 13, 2018
Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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.
  • 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,
  • 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 ]
    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.
  • Change from Baseline Healthy Behaviors [ Time Frame: Baseline, 3, 6 months ]
    Behavioral Risk Factor Surveillance System
  • Change from Baseline Perceived Stress [ Time Frame: Baseline, 3, 6 months ]
    Perceived Stress Scale (PSS)
  • Change from Baseline Depression [ Time Frame: Baseline, 3, 6 months ]
    Patient Health Questionnaire-9
  • Change from Baseline Self-Esteem [ Time Frame: Baseline, 3, 6 months ]
    Rosenberg Self-Esteem Scale
  • Change from Baseline Psychological Need Satisfaction: Autonomy, Competence, Relatedness [ Time Frame: Baseline, 3, 6 months ]
    Need Satisfaction Scale
  • Change from Baseline Body Mass Index: BMI [ Time Frame: Baseline, 3, 6 months ]
  • Change from Baseline Blood Pressure [ Time Frame: Baseline, 3, 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enduring Happiness and Continued Self-Enhancement
Official Title  ICMJE Enduring Happiness and Continued Self-Enhancement
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Happiness
Intervention  ICMJE Behavioral: ENHANCE: Enduring Happiness and Continued Self-Enhancement
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 Arms  ICMJE
  • 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.
    Intervention: Behavioral: ENHANCE: Enduring Happiness and Continued Self-Enhancement
  • No Intervention: Waiting Group Control
    The waiting group control will complete the same assessments as the experimental group but without receiving the intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2016)
154
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
160
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Participants ages 25 to 75

Exclusion Criteria:

• Major Depression

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782611
Other Study ID Numbers  ICMJE 20160044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Kostadin Kushlev, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE University of British Columbia
Investigators  ICMJE Not Provided
PRS Account University of Virginia
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP