insomnia primary insomnia sleep problems
Conditions
Interventions
CBT-I.
All participants will receive web-based, personalized cognitive behavioral
treatment (SOMNIO), the first treatment factor, for four weeks. Half of the
participants will be randomized to rece
the other half to a waitlist for CBT-I.
Cognitive behavioral therapy (CBT) is a combination of psychological and
behavioral treatments. When these treatments focus on sleep improvement, the
term CB
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants will only be included if they can be classified to one of the four most prevalent insomnia phenotypes. Participants have to be at least 18 years old and less than 70 years old
Exclusion criteria
Exclusion criteria: People will be excluded if they report an eye disease incompatible with light treatment (aphakia or retinopathy). People diagnosed with any cardiovascular or movement disorder will be excluded. People doing shiftwork will be excluded, Participants will be excluded if their baseline level and timing of activity, bright light or warming before bedtime is similar to the CT interventions planned. People currently diagnosed with a psychiatric or neurological disorder are excluded from participation. People using sleep medication will also be excluded (or asked to stop at least 3 months prior to enrolling in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the change from week 1 to week 6 on subjective sleep efficiency. In both weeks, the complaints are queried daily through internet diary. It should be noted that the diagnosis and treatment evaluation of insomnia is primarily based on these subjective complaints. The composite measure includes morning diary ratings of difficulties falling asleep, difficulties maintaining sleep, early morning awakening and non-restorative sleep. It moreover includes evening diary ratings of the nine major daytime functioning complaints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are meant to support the subjective evaluations, and concern actigraphically estimated objective sleep parameters including sleep onset latency, sleep duration, wake after sleep onset, sleep efficiency and the average durations of unperturbed periods of sleep and wakefulness. At three time points during the protocol, participants will fill out additional questionnaires through the NSR website. One addresses the expectations of treatment effect (to verify the placebo), or the subjective view on treatment outcome. Other surveys address possible dysfunctional beliefs and attitudes regarding sleep (DBAS), depression and anxiety (HADS), arousal (PSAS and AROUS), functional health (SF-36), mood (PANAS), sleep effort (GSES), self-efficacy (SSES) and sleep locus of control (SLOC). A final questionnaire quantitatively estimates the costs associated with insomnia (TiC-P). The Composite International Diagnostic Interview * Short Form (CIDI-SF) will be administered at three years follow-up to assess depression and the Life Experiences Survey will be used for assessing life experiences. | — |
Countries
Netherlands
Outcome results
None listed