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van CCT (UK)

van CCT (UK)

Een internetinterventie voor mensen met slaapproblemen.

- candidate number6782
- NTR NumberNTR2132
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-dec-2009
- Secondary IDsNL29947.029.09 CCMO
- Public TitleEen internetinterventie voor mensen met slaapproblemen.
- Scientific TitleA guided web-based intervention for insomnia: a pilot study.
- hypothesisIn this pilot study we test the feasibility and effectiveness of a internet based intervention for sleep problems.
- Healt Condition(s) or Problem(s) studiedSleepproblems, Insomnia
- Inclusion criteria1. 18 years or older;
2. Having sleep problems (being awake for at least 30 minutes a night, for at least 3 nights a week, for at least 3 months).
- Exclusion criteriaVery high scores on depression or anxiety questionnaires.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate31-dec-2010
- Target number of participants100
- InterventionsIntervention:
The intervention, which is based on existing psychological treatment for sleep problems, will be offered through the Internet. It focuses on the following elements: (1) psycho-education about sleep and sleep disorders (2) stimulus-control (only going to bed when tired, getting out of bed at the same time every day) (3) sleep restriction (reduction of the time spent in bed to the average number of hours slept) (4) sleep hygiene (information about helpful and harmful daily habits) (5) relaxation, and (6) cognitive restructuring (modifying dysfunctional beliefs about sleep and insomnia). The intervention consists of 6 weekly lessons. In every lesson the patients finds new information and is asked to do homework. The patients will receive online feedback on this homework by coaches.

There is a waitlist control group. The people in the control group will receive the internet intervention 3 months after randomization (after the follow-up measurement).
- Primary outcomeSleep diary (sleep onset latency, total sleep time, sleep efficiency, sleep quality).
- Secondary outcome1. Insomia severity;
2. Fatigue;
3. Depressive symptoms;
4. Anxiety symptoms;
5. Quality of life.
- TimepointsBaseline, 6 and 13 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD. Annemieke Straten, van
- CONTACT for SCIENTIFIC QUERIESPhD. Annemieke Straten, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryInsomnia is very prevalent. About 33% of the population suffers from one or more symptoms. Treatment usually consists of sleepmedication which has a number of important drawbacks. Cognitive-behavioral therapy is at least as effective but is seldomly offered because it is not available. We developed an internet intervention based on the usual CBT face-to-face treatment. In this pilot study we want to examine (1) feasibility and (2) effectiveness.
- Main changes (audit trail)
- RECORD3-dec-2009 - 18-dec-2009

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