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The Teleac course for insomnia: a RCT.


- candidate number0
- NTR NumberNTR62
- ISRCTNISRCTN37858178
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR5-jul-2005
- Secondary IDsNFGV – 5978 (national fund public mental health) 
- Public TitleThe Teleac course for insomnia: a RCT.
- Scientific TitleA randomised trial of a behavioural training programme through television for patients with insomnia.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedInsomnia
- Inclusion criteriaA sleep problem defined as lying awake for at least 30 minutes for at least 3 nights a week for at least 1 month.
- Exclusion criteriaA high score on the screener for depression (CESD) or anxiety (HADS).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2005
- planned closingdate7-dec-2006
- Target number of participants300
- InterventionsA behavioural training programme for insomnia will be broadcasted by Teleac this fall. This trial will take place before the start of the broadcasting with 3 groups:
1. Each week a DVD is sent to the patient’s home for 6 weeks. Each DVD contains part of the behavioural training programme (25 minutes each) + book that belongs to the this television programme;
2. Same as the first condition without the book;
3. Waiting list control group. These patients may watch the regular television programme later on when broadcasted by Teleac.
- Primary outcomeSleepefficiency posttreatment (6 weeks) and 3 months later .
- Secondary outcomeQuality of sleep, cognitions about sleep, use of sleep medication, symptoms of depression and anxiety, quality of life, absence of work, health care use; all measured posttreatment (6 weeks) and 3 months later.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD. Annemieke Straten, van
- CONTACT for SCIENTIFIC QUERIESPhD. Annemieke Straten, van
- Sponsor/Initiator VU University Medical Center, Department of Clinical Psychology
- Funding
(Source(s) of Monetary or Material Support)
NFGV – National Fund public mental health (Nationaal Fonds Geestelijke Volksgezondheid), VU University Medical Center, Department of Clinical Psychology
- PublicationsN/A
- Brief summaryPatients are not masked (no therapists or interviewers participate in this trail; questionnaires are sent through mail or Internet).
100 patients in each condition.
- Main changes (audit trail)
- RECORD28-jul-2005 - 14-sep-2009


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