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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Restriction followed by additional CBT-i components | Experimental | 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 | Active Comparator | 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 no intervention | Active Comparator | 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. |
|
| Sleep Compression followed by no intervention | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Restriction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography | Ambulatory objective sleep stage and sleep timing measure | One week before treatment (Week -1) and at week 1, week 3, week 5, and week 10 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna Jernelöv, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40205789 | Derived | Jernelov S, Rosen A, Forsell E, Blom K, Ivanova E, Maurex L, Jansson-Frojmark M, Akerstedt T, Kaldo V. Is sleep compression therapy non-inferior to sleep restriction therapy? A single-blind randomized controlled non-inferiority trial comparing sleep compression therapy to sleep restriction therapy as treatment for insomnia. Sleep. 2025 Aug 14;48(8):zsaf093. doi: 10.1093/sleep/zsaf093. | |
| 33813233 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Sleep Compression | Behavioral | 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. |
|
| Additional CBT-i components | Behavioral | 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. |
|
| 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 |
| Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10) |
| Adverse Events | Self-report questionnaires and interviews | Week 2, week 4 and week 5 |
| Sleep Problems Acceptance Questionnaire | Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks |
| Derived |
| Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16. |
| D001523 |
| Mental Disorders |