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van CCT (UK)

van CCT (UK)

No Fun No Glory

- candidate number22899
- NTR NumberNTR5498
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2015
- Secondary IDs016.130.002 NWO
- Public TitleNo Fun No Glory
- Scientific TitleA biopsychosocial investigation of how young people suffering from persistent loss of pleasure may gain pleasure back again.
- hypothesis1) Personalized lifestyle advices are an effective way to reduce loss of pleasure in young individuals 2) Exposure to a tandem skydive experience fosters the recommended lifestyle changes that can restore the ability to experience pleasure
- Healt Condition(s) or Problem(s) studiedAnhedonia
- Inclusion criteria* Age 18-24 years
* Fluent in Dutch
* Low pleasure level (< 25th percentile), which is considered a loss compared to normally experienced pleasure, for at least 2 months
* Willingness to perform a tandem skydive
- Exclusion criteria* Inability to keep an electronic diary three times a day
* Current professional treatment for psychiatric problems
* Current use of psychopharmaca
* Epilepsy
* Pregnancy
* Conditions that make it impossible to be attached to the tandemmaster (e.g., loose prostheses)
* Height of more than 2 meters
* Weight of more than 95 kg
* Inability to raise one’s legs 90 degrees
* Significant visual or hearing impairments
* Prior experience with skydiving, bungee jumping, base jumping, or skyjumping
* Cardiovascular complaints/problems
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-jan-2015
- planned closingdate31-dec-2016
- Target number of participants60
- InterventionsThe participants are randomly assigned to three groups. The first month is used for observation (diary data) in all three anhedonic groups. At the start of the second month (the first intervention month), one group receives personalized lifestyle advice based on patterns observed in the first month. The second group receives personalized lifestyle advice plus a tandem skydive. The third group receives neither lifestyle advice nor a tandem skydive. At the start of the third month, all participants are free to choose between no intervention, (continued) lifestyle advice, and/or (another) tandem skydive.
- Primary outcomeThe main study endpoint of the intervention study is the level of pleasure, as measured in the daily questionnaires. Change in pleasure will be evaluated both intraindividually (time series approach) and interindividually (multilevel approach).
- Secondary outcomeSecondary endpoints concern possible intervention effects in monthly-reported pleasure in different dimensions (motivational, anticipatory, consummatory) and different domains (perceptual, physical, social). Other endpoints that will be explored are changes in potential biomarkers, perceived physical and mental health, and positive and negative affect. Furthermore, the extent to which the lifestyle advice will lead to actual lifestyle change will be investigated by comparing the level and slope of the lifestyle variables in the pre- and post-intervention period.
- TimepointsDiary questionnaires three times a day for three months; more extensive questionnaires and blood samples at the start of the study and after 1, 2, 3, 9, and 15 months.
- Trial web
- statusinclusion stopped: follow-up
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
NWO VICI grant
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD22-sep-2015 - 5-jan-2016

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