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van CCT (UK)

van CCT (UK)

Treatment of insomnia with behavioral therapy

- candidate number28309
- NTR NumberNTR6867
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2017
- Secondary IDs2017-CP-8305  Commissie ethiek van de UvA
- Public TitleTreatment of insomnia with behavioral therapy
- Scientific TitleSleep restriction therapy for people with insomnia and depressive complaints
- hypothesisSleep restriction therapy is effective for depressive and insomnia complaints
- Healt Condition(s) or Problem(s) studiedInsomnia, Subtreshold depression
- Inclusion criteria- 18 years or older
- DSM-5 insomnia
- Insomnia Severity Index score ≥ 10
- Sleep efficiency (percentage of time in bed spent asleep) < 85%
- Patient Health Questionnaire depression scale ≥ 10
- Available for ten consecutive weeks
- Exclusion criteria- Previous CBT-I (lifetime)
- Started psychotherapy <6 months ago
- Prescribed medication for psychological problems
- Pregnancy/breastfeeding
- Shift work
- Hypomanic/manic period (lifetime) (SCID)
- Severe depressive complaints (BDI score > 30)
- Alcohol or drug abuse (SCID section)
- Probable sleep apnea (screener Wilson et al., 2010)
- Psychosis/schizophrenia (screener/SCID)
- Suicidal ideation (SCID and 5 items based on the Mini International Neuropsychiatric Interview diagnostic interview; Sheehan et al., 1998)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-dec-2017
- planned closingdate1-jan-2019
- Target number of participants15
- InterventionsThe participants will receive 6 weeks of sleep restriction therapy (including a sleep diary and weekly assessments; Kyle et al., 2015; Spielman et al., 1987). The goal of SRT is to increase the homeostatic sleep drive by restricting time in bed and to re-establish circadian rhythm by applying regular bedtime and rising time. SRT will be administered by the therapist that also did the intake assessment. SRT will start with a face-to-face session (week 1) explaining the rationale. After that 5 more weeks are used for titration of the bedtimes. In week 2, 4, 6 and 6 of the intervention there will be contact via the phone. In week 3 of the intervention there will be another face-to-face session. Treatment will be delivered by practitioners at the PsyPoli, UvA.
- Primary outcomeDepressive complaints measured with the Patient Health Questionnaire (with and without sleep item)
- Secondary outcome- Depressive complaints measured with the Beck Depression Inventory (BDI)
- Insomnia severity (insomnia severity index and sleep diary)
- Daily mood and sleep quality assessment
- Behavioral activation (behavioral activation scale for depression; BADS-SF)
- Objective sleep (actigraphy)
- SCID diagnosis depression
- TimepointsFor this study we will employ a case series design.
Participants will fill out the following measurements:

T0_1: Screener to assess eligibility and measure PHQ and ISI
T0_2: face-to-face intake/assessment to further assess eligibility and clinical diagnosis insomnia/depression/anxiety and primary and secondary measures

T0-T10 (period of 10 weeks): Weekly ISI/PHQ/BADS-SF and daily sleep diary and mood estimate

T4: End wait period/start treatment.
--> additional assessment insomnia/depression/substance abuse diagnosis and assessment BDI

T10 (post-test): face-to-face assessment.
--> additional assessment insomnia/depression/anxiety/substance abuse/ diagnosis and assessment BDI
- Trial web siteNone
- statusopen: patient inclusion
- Sponsor/Initiator University of Amsterdam (UvA), Department of Clinical Psychology
- Funding
(Source(s) of Monetary or Material Support)
University of Amsterdam (UvA), Department of Clinical Psychology
- Publications
- Brief summarySleep restriction therapy (SRT) is proposed as one of the most active treatment components for insomnia (Kyle et al. 2015). In this study we want to establish whether single component SRT ameliorates depressive symptoms. To date, there have only been a few studies on SRT, and none of them investigated the effects on depressive symptoms. Therefore, a series of single case studies (n=9; with maximum n=15) is proposed.
- Main changes (audit trail)
- RECORD6-dec-2017 - 15-dec-2017

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