InsomniaCompRestNCT02743338
CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia
A study testing Sleep Restriction, Sleep Compression and Additional CBT-i components in people with Insomnia, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Restriction, Sleep Compression and Additional CBT-i components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
Stockholm, 14186
About this study
Official title: CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia
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.
- Conditions
- Insomnia
- Being tested
- Sleep Restriction, Sleep Compression, Additional CBT-i components
- Keywords
- Sleep Restriction, Sleep Compression, Cognitive Behavioral Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionBehavioural
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.
Sleep CompressionBehavioural
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 componentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Restriction; Behavioral: Additional CBT-i components |
| 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. Receives: Behavioral: Sleep Compression; Behavioral: Additional CBT-i components |
| 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. Receives: Behavioral: Sleep Restriction |
| 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. Receives: Behavioral: Sleep Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Adverse Events
Self-report questionnaires and interviews
Measured: Week 2, week 4 and week 5
Sleep Problems Acceptance Questionnaire
Measured: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
- Investigators
- Susanna Jernelöv, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743338
- Sponsor's protocol ID
- 2016/44-31/4
- Acronym
- CompRest
- Status last verified
- Sep 2022
- First submitted
- 12 Apr 2016
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40205789Kraepelien 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.
PubMed 33813233
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT02743338
- Acronym / sponsor ID
- CompRest / 2016/44-31/4
- Conditions
- Insomnia
- Keywords
- Sleep Restriction, Sleep Compression, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction followed by additional CBT-i components | Experimental | Behavioral: Sleep Restriction, Behavioral: Additional CBT-i componentsSleep 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 | Behavioral: Sleep Compression, Behavioral: Additional CBT-i componentsSleep 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 | Behavioral: Sleep RestrictionSleep 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 | Behavioral: Sleep CompressionSleep 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep RestrictionBehavioral 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. | Behavioural | Sleep Restriction followed by additional CBT-i components, Sleep Restriction followed by no intervention |
| Sleep CompressionBehavioral 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. | Behavioural | Sleep Compression followed by additional CBT-i components, Sleep Compression followed by no intervention |
| Additional CBT-i componentsAfter 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. | Behavioural | Sleep Compression followed by additional CBT-i components, Sleep Restriction followed by additional CBT-i components |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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.
4 secondary outcomes
Sleep diary
Time frame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Actigraphy
Time frame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Adverse Events
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Derived from this study: PubMed 40205789Jernelov 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.
- Derived from this study: PubMed 33813233Kraepelien 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Jernelöv, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction, Sleep Compression and Additional CBT-i components in people with Insomnia, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743338, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.