- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02041741
Improving Happiness in Flanders (HAP-FLA)
Happiness in Flanders: A Randomized, Wait-List Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized trial has two aims:
- First, it investigates the efficacy of two different happiness interventions in increasing feelings of happiness in the Flemish general population using a wait-list controlled design.
- Second, this study aims to identify predictors of response in both interventions ("what works for whom?")
Methods
Design and procedure
- Participants will be contacted through social media and directed to a website that is specifically designed for this study.
- All participants who register for the study first will electronically sign an informed consent and will be asked to complete a brief battery of questionnaires online (base line measures) before randomization.
Participants then are assigned randomly using a block-randomized design to one of the three conditions using a computerized algorithm:
- a condition in which daily small and concrete happiness tips are sent to participants during one month via email (n=400)
- a condition in which weekly more in-depth happiness tips with a (doing and experiencing) task are given during one month via email (n=400)
- a wait-list condition (1 month); these participants will be subsequently (after the end of the 4-week intervention) randomized to condition (a) or (b) (n=400) using a block-randomized design.
- All participants will be assessed weekly during the intervention (see below) and followed-up 6 months after the end of the study.
Measures
Participants will complete a detailed demographic questionnaire.
Primary outcome measures:
- Subjective Happiness Scale (SHS; Lyubomirsky & Lepper, 1999)
- Steen Happiness Inventory (SHI; Seligman, Steen, Park, & Peterson, 2005)
Secondary outcome measures
- Positive and Negative Affect Scales (PANAS; Watson, Clark, & Tellegen, 1988)
- Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
- Warwick Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)
- Brief Symptom Inventory (Korte KlachtenLijst; KKL; Lange, & Appelo, 2007)
Predictors of outcome
- Meaning in Life Questionnaire (MLQ; Steger, Frazier, Oishi, & Kaler, 2006)
- Depressive Experiences Questionnaire (DEQ; Blatt, D'Afflitti, & Quinlan, 1976)
- Experiences in Close Relationships-Revised (ECR-R, Fraley, Waller, & Brennan, 2000)
- Kentucky Inventory of Mindfulness (KIMS; Baer, Smith, & Allen, 2004)
- Toronto Alexithymia Scale (TAS; Bagby, Parker, & Taylor, 1994)
Data analyses
Repeated measures Anova and multilevel modeling will be used to assess differences between the three conditions in primary and secondary outcomes at the end of the intervention and at follow-up. Regression analyses and growth curve modeling will be used to examine the effects of the predictors on primary and secondary outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- Faculty of Psychology and Educational Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sufficient fluency in Flemish
- at least 18 years of age
Exclusion Criteria:
- no fluency in Flemish
- living outside of Flanders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Weekly tips
Daily small and concrete happiness tips
|
Participants in this condition receive weekly a more in-depth tip to increase feelings of happiness involving a (doing and experiencing) task
|
Active Comparator: Daily Tips
Weekly more in-depth happiness tips involving an active (doing and experiencing) task
|
Participants in this condition receive daily a set of small tips aimed at increasing happiness
|
No Intervention: Wait-List Control
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective Happiness Scale
Time Frame: 4 weeks after start of intervention and 6 months after end of intervention
|
4 weeks after start of intervention and 6 months after end of intervention
|
Steen Happiness Inventory
Time Frame: 4 weeks after start of intervention and 6 months after end of intervention
|
4 weeks after start of intervention and 6 months after end of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive and Negative Affect Scale (PANAS)
Time Frame: 4 weeks after start of intervention and 6 months after end of intervention
|
4 weeks after start of intervention and 6 months after end of intervention
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 4 weeks after start of intervention and 6 months after end of intervention
|
4 weeks after start of intervention and 6 months after end of intervention
|
Warwick Edinburgh Mental Well-Being Scale
Time Frame: 4 weeks after start of intervention and 6 months after end of intervention
|
4 weeks after start of intervention and 6 months after end of intervention
|
Brief Symptom Inventory (KKL, Korte KlachtenLijst)
Time Frame: 4 weeks after start of intervention and 6 months after end of intervention
|
4 weeks after start of intervention and 6 months after end of intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Meaning in Life Questionnaire
Time Frame: Start of intervention (predictor variable)
|
Start of intervention (predictor variable)
|
Depressive Experiences Questionnaire (DEQ)
Time Frame: Start of intervention (predictor variable)
|
Start of intervention (predictor variable)
|
Experiences in Close Relationships-Revised (ECR-R)
Time Frame: Start of intervention (predictor variable)
|
Start of intervention (predictor variable)
|
Kentucky Inventory of Mindfulness (KIMS)
Time Frame: Start of intervention (predictor variable)
|
Start of intervention (predictor variable)
|
Toronto Alexithymia Scale (TAS)
Time Frame: Start of intervention (predictor variable)
|
Start of intervention (predictor variable)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Luyten, PhD, KULeuven, Belgium
- Study Director: Mia Leijssen, PhD, KULeuven, Belgium
- Study Director: Sara Casalin, PhD, KULeuven, Belgium
- Study Director: Jessie Dezutter, PhD, KULeuven, Belgium
Publications and helpful links
General Publications
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.
- Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206. doi: 10.1177/1073191104268029.
- Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.
- Fraley RC, Waller NG, Brennan KA. An item response theory analysis of self-report measures of adult attachment. J Pers Soc Psychol. 2000 Feb;78(2):350-65. doi: 10.1037//0022-3514.78.2.350.
- Lyubomirsky, S., & Lepper, H. S. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46, 137-155.
- Blatt SJ, D'Afflitti JP, Quinlan DM. Experiences of depression in normal young adults. J Abnorm Psychol. 1976 Aug;85(4):383-9. doi: 10.1037//0021-843x.85.4.383. No abstract available.
- Lange, A., & Appelo, M. (2007). Handleiding Korte Klachten Lijst (KKL) [Manual for the Brief Symptom Inventory]. Houten, The Netherlands: Bohn Stafleu Van Loghum.
- Steger, M. F., Frazier, P., Oishi, S., & Kaler, M. (2006). The Meaning in Life Questionnaire: Assessing the presence of and search for meaning in life. Journal of Counseling Psychology, 53(1), 80-93. doi: 10.1037/0022-0167.53.1.80
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HAP-FLA
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