CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia
- Conditions
- Insomnia
- Interventions
- Behavioral: Sleep CompressionBehavioral: Sleep RestrictionBehavioral: Additional CBT-i components
- Registration Number
- NCT02743338
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia Disorder according to DSM-V
- Sufficient language skills
- Having access to Internet to fill out forms and participating in treatment
- Not foresee obstacles to participating in treatment during the coming 20 weeks, or participating in measurements during the coming year.
- Sleep disorders requiring other treatment
- High consumption of alcohol/drugs that affect sleep
- Somatic or psychiatric conditions counter-indicative of treatments given in the study, requiring acute care, or with symptoms and level of functioning affecting the ability to participate in the treatment programs.
- Working (night) shifts
- Ongoing psychological treatment for Insomnia with sleep restriction or sleep compression as a treatment component - also previous such treatment can be excluding
- Use of sleep medication in such a way that may hinder the implementation of the methods in this treatment
- Pre-treatment measurements not finished within the given time-frame.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Compression followed by additional CBT-i components Sleep Compression Sleep Compression treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks. Sleep Restriction followed by additional CBT-i components Additional CBT-i components Sleep Restriction treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks. Sleep Compression followed by additional CBT-i components Additional CBT-i components Sleep Compression treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks. Sleep Compression followed by no intervention Sleep Compression Sleep Compression treatment during 5+5 weeks. Followed by NOT being offered or informed of an additional intervention consisting of other ICBT-i components during 10 weeks. Sleep Restriction followed by additional CBT-i components Sleep Restriction Sleep Restriction treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks. Sleep Restriction followed by no intervention Sleep Restriction Sleep Restriction treatment during 5+5 weeks. Followed by NOT being offered or informed of an additional intervention consisting of other ICBT-i components during 10 weeks.
- Primary Outcome Measures
Name Time Method Insomnia Severity Index (ISI) Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks 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.
- Secondary Outcome Measures
Name Time Method Sleep diary Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10) 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
Adverse Events Week 2, week 4 and week 5 Self-report questionnaires and interviews
Sleep Problems Acceptance Questionnaire Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks Actigraphy Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10) 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
Trial Locations
- Locations (1)
Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
🇸🇪Stockholm, Sweden