search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Treatment of chronic insomnia via a Smartphone application


- candidate number23692
- NTR NumberNTR5560
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-aug-2015
- Secondary IDs2014-CP-3798 
- Public TitleTreatment of chronic insomnia via a Smartphone application
- Scientific TitleCognitive Behavioral Therapy for Insomnia via a Smartphone application - RCT
- ACRONYM
- hypothesisAbout 10-15% of the population suffers from chronic insomnia. Structurally poor sleep can have unpleasant consequences for people's health and quality of life. Therefore, proper treatments are of great importance. Fortunately, Cognitive Behavioral Therapy for Insomnia (CBT-I) shows long-term effects. This study researches whether CBT-I can also be offered via a Smartphone application. Health Conditions or Problems studied: Insomnia, Sleep disorder, Insomnie, Slaapprobleem, Cognitive Behaviour Therapy for Insomnia
- Healt Condition(s) or Problem(s) studiedSleepproblems, Insomnia, Cognitive behavior therapy
- Inclusion criteriainsomnia according to DSM-5, at least 18 years old, stable medication, valid e-mail address, internet connection, Android (version 4.2 or higher) Smartphone
- Exclusion criteriaOn average less than five hours of sleep reported in the online sleep diary (pre-measure), ISI score below 7 previous cognitive behavioral therapy for insomnia, start psychotherapy in the last six months, psychosis / schizophrenia, alcohol or drug abuse, complaints indicating sleep apnea, shiftwork, women who are pregnant or breastfeeding, current depressive episode
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-mei-2016
- Target number of participants180
- InterventionsThe therapy for insomnia is presented through a smartphone. The therapy consists of a) relaxation exercises, b) sleep hygiene, c) registering the own sleep, and d) sleep restriction. The lessons can be done in six weeks. Participants will have seven weeks to complete the training. The app will send reminders for the exercises, and adjust the exercises if needed.
- Primary outcomeInsomnia Severity Index (ISI), Dysfunctional beliefs about sleep (DBAS), Anxiety (HADS), Depression (CES-D), Sleep (PSQI)
- Secondary outcomeSecondary Outcomes: sleep diary (average total sleep time, sleep efficiency)
- Timepointspre-measure (week 0), post-measures (week 7), 3-month follow-up
- Trial web sitewww.ikgalekkerslapen.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc Corine Horsch
- CONTACT for SCIENTIFIC QUERIES Jaap Lancee
- Sponsor/Initiator University of Amsterdam (UvA), Utrecht University (UU), TU Delft
- Funding
(Source(s) of Monetary or Material Support)
Philips and Technology Foundation STW, Nationaal Initiatief Hersenen & Cognitie (NIHC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-feb-2016 - 7-feb-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl