This study includes two consecutive sub-trials. Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but lately, adverse effects related to SR have been reported. A treatment method with similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to have similar effects to SR but without the adverse effects. The first sub-trial thus aims at directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects of CBT-i components given as an add-on treatment to a randomized selection of half participants in each original treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
234
Behavioral component of CBT-i. Sleep restrictions includes curtailing bed time to match sleep time as registered during the first week of treatment, and expanding bed time contingent upon increased sleep efficiency, until optimal balance between sleep time and sleep efficiency is reached. The first five weeks, therapist support is provided via written messages. The next five weeks, patient works independently. At the end of tenth treatment week, therapist and patient make plan for future.
Behavioral component of CBT-i. Sleep compression includes gradually compressing bed time over several weeks to approach sleep time as registered during the first week of treatment, and stopping compression when optimal balance between sleep time and sleep efficiency is reached. The first five weeks, therapist support is provided via written messages. The next five weeks, patient works independently. At the end of tenth treatment week, therapist and patient make plan for future.
After 5+5 weeks of either Sleep Restriction or Sleep Compression, a randomized sample from each treatment Group is offered additional components of CBT-i, such as Stimulus Control, Cognitive Restructuring, Relaxation and Visualization for 10 weeks, without therapist support. Component allocation based on individual analysis.
Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
Stockholm, Sweden
Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring change in insomnia severity. Bastien, C. H., Vallières, A., \& Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.
Time frame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Sleep diary
Daily self-ratings on a number of sleep parameters, resulting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjective sleep quality and daytime functioning
Time frame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Actigraphy
An actigraph is placed on the participant's arm for one week. They measure participants' activity in the form of movements. It will be used for acquiring sleep data and calculate sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings and daytime activity
Time frame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Adverse Events
Self-report questionnaires and interviews
Time frame: Week 2, week 4 and week 5
Sleep Problems Acceptance Questionnaire
Time frame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
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