Improving Happiness in Flanders

Happiness in the General Population Clinical Trial

— HAP-FLA  

Official title:

Happiness in Flanders: A Randomized, Wait-List Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041741
• Other study ID #: HAP-FLA
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: May 28, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the effects of two different types of interventions aimed at increasing happiness in the Flemish general population as compared to individuals that receive no intervention.

Description:

This randomized trial has two aims:

1. 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.

2. 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:

1. a condition in which daily small and concrete happiness tips are sent to participants during one month via email (n=400)

2. 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)

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10863
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sufficient fluency in Flemish

• at least 18 years of age

Exclusion Criteria:

• no fluency in Flemish

• living outside of Flanders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Happiness in the General Population

Intervention

Behavioral:
• Weekly tips
Participants in this condition receive weekly a more in-depth tip to increase feelings of happiness involving a (doing and experiencing) task
• Daily Tips
Participants in this condition receive daily a set of small tips aimed at increasing happiness

Locations

Country	Name	City	State
Belgium	Faculty of Psychology and Educational Sciences	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (11)

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. — View Citation

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. — View Citation

Blatt SJ, D'Afflitti JP, Quinlan DM. Experiences of depression in normal young adults. J Abnorm Psychol. 1976 Aug;85(4):383-9. — View Citation

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. — View Citation

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. — View Citation

Lange, A., & Appelo, M. (2007). Handleiding Korte Klachten Lijst (KKL) [Manual for the Brief Symptom Inventory]. Houten, The Netherlands: Bohn Stafleu Van Loghum.

Lyubomirsky, S., & Lepper, H. S. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46, 137-155.

Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Meaning in Life Questionnaire		Start of intervention (predictor variable)	No
Other	Depressive Experiences Questionnaire (DEQ)		Start of intervention (predictor variable)	No
Other	Experiences in Close Relationships-Revised (ECR-R)		Start of intervention (predictor variable)	No
Other	Kentucky Inventory of Mindfulness (KIMS)		Start of intervention (predictor variable)	No
Other	Toronto Alexithymia Scale (TAS)		Start of intervention (predictor variable)	No
Primary	Subjective Happiness Scale		4 weeks after start of intervention and 6 months after end of intervention	No
Primary	Steen Happiness Inventory		4 weeks after start of intervention and 6 months after end of intervention	No
Secondary	Positive and Negative Affect Scale (PANAS)		4 weeks after start of intervention and 6 months after end of intervention	No
Secondary	Patient Health Questionnaire-9 (PHQ-9)		4 weeks after start of intervention and 6 months after end of intervention	No
Secondary	Warwick Edinburgh Mental Well-Being Scale		4 weeks after start of intervention and 6 months after end of intervention	No
Secondary	Brief Symptom Inventory (KKL, Korte KlachtenLijst)		4 weeks after start of intervention and 6 months after end of intervention	No