Happiness in the General PopulationHAP-FLANCT02041741
Improving Happiness in Flanders
A study testing Weekly tips and Daily Tips in people with Happiness in the General Population, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Happiness in the General Population
- What is being tested?
- Weekly tips and Daily Tips
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,863 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Oct 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sufficient fluency in Flemish
- at least 18 years of age
Who cannot join
- no fluency in Flemish
- living outside of Flanders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Happiness in Flanders: A Randomized, Wait-List Controlled Study
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.
Read the 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.
- Conditions
- Happiness in the General Population
- Being tested
- Weekly tips, Daily Tips
- Keywords
- happiness, well-being, distress, positive psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly tipsBehavioural
Participants in this condition receive weekly a more in-depth tip to increase feelings of happiness involving a (doing and experiencing) task
Daily TipsBehavioural
Participants in this condition receive daily a set of small tips aimed at increasing happiness
| Study group | Role | What they receive |
|---|---|---|
| Weekly tips | Active comparator | Daily small and concrete happiness tips Receives: Behavioral: Weekly tips |
| Daily Tips | Active comparator | Weekly more in-depth happiness tips involving an active (doing and experiencing) task Receives: Behavioral: Daily Tips |
| Wait-List Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Happiness Scale
Measured: 4 weeks after start of intervention and 6 months after end of intervention
Steen Happiness Inventory
Measured: 4 weeks after start of intervention and 6 months after end of intervention
Secondary outcomes (4)
Positive and Negative Affect Scale (PANAS)
Measured: 4 weeks after start of intervention and 6 months after end of intervention
Patient Health Questionnaire-9 (PHQ-9)
Measured: 4 weeks after start of intervention and 6 months after end of intervention
Warwick Edinburgh Mental Well-Being Scale
Measured: 4 weeks after start of intervention and 6 months after end of intervention
Brief Symptom Inventory (KKL, Korte KlachtenLijst)
Measured: 4 weeks after start of intervention and 6 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Happiness in the General PopulationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10,863 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Luyten, PhD, Principal investigator, KULeuven, BelgiumMia Leijssen, PhD, Study director, KULeuven, BelgiumSara Casalin, PhD, Study director, KULeuven, BelgiumJessie Dezutter, PhD, Study director, KULeuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041741
- Sponsor's protocol ID
- HAP-FLA
- Acronym
- HAP-FLA
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16045394Lyubomirsky, S., & Lepper, H. S. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46, 137-155.
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.
PubMed 3397865Kroenke 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.
PubMed 11556941Blatt 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.
PubMed 956505Fraley 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.
PubMed 10707340Bagby 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.
PubMed 8126686Tennant 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.
PubMed 18042300Lange, 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
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.
PubMed 15358875
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Happiness in Flanders: A Randomized, Wait-List Controlled Study
- ClinicalTrials.gov ID
- NCT02041741
- Acronym / sponsor ID
- HAP-FLA / HAP-FLA
- Conditions
- Happiness in the General Population
- Keywords
- happiness, well-being, distress, positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,863 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jan 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weekly tips | Active comparator | Behavioral: Weekly tipsDaily small and concrete happiness tips |
| Daily Tips | Active comparator | Behavioral: Daily TipsWeekly more in-depth happiness tips involving an active (doing and experiencing) task |
| Wait-List Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sufficient fluency in Flemish
- at least 18 years of age
Key exclusion criteria (2 listed)
- no fluency in Flemish
- living outside of Flanders
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 |
|---|---|---|
| Weekly tipsParticipants in this condition receive weekly a more in-depth tip to increase feelings of happiness involving a (doing and experiencing) task | Behavioural | Weekly tips |
| Daily TipsParticipants in this condition receive daily a set of small tips aimed at increasing happiness | Behavioural | Daily Tips |
Primary outcome
Subjective Happiness Scale
Time frame: 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 secondary outcomes
Positive and Negative Affect Scale (PANAS)
Time frame: 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
Warwick Edinburgh Mental Well-Being Scale
Time frame: 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
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 29 May 2015.
- Background: PubMed 16045394Seligman 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.
- BackgroundLyubomirsky, S., & Lepper, H. S. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46, 137-155.
- Background: PubMed 3397865Watson 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 956505Blatt 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.
- Background: PubMed 10707340Fraley 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.
- Background: PubMed 8126686Bagby 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.
- Background: PubMed 18042300Tennant 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.
- BackgroundLange, A., & Appelo, M. (2007). Handleiding Korte Klachten Lijst (KKL) [Manual for the Brief Symptom Inventory]. Houten, The Netherlands: Bohn Stafleu Van Loghum.
- BackgroundSteger, 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
- Background: PubMed 15358875Baer 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.
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.
Patrick Luyten, PhD principal investigator
KULeuven, Belgium
Mia Leijssen, PhD study director
KULeuven, Belgium
Sara Casalin, PhD study director
KULeuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly tips and Daily Tips in people with Happiness in the General Population, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 2 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Subjective Happiness Scale (time frame: 4 weeks after start of intervention and 6 months after end of intervention). The study lists 2 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 NCT02041741, which also lists 11 linked publications.
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 29 May 2015.