CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia

NCT ID: NCT02743338

Last Updated: 2022-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sleep Restriction followed by 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.

Group Type EXPERIMENTAL

Sleep Restriction

Intervention Type 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.

Additional CBT-i components

Intervention Type 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.

Sleep Compression followed by 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.

Group Type ACTIVE_COMPARATOR

Sleep Compression

Intervention Type 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

Intervention Type 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.

Sleep Restriction followed by no intervention

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.

Group Type ACTIVE_COMPARATOR

Sleep Restriction

Intervention Type 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.

Sleep Compression followed by no intervention

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.

Group Type ACTIVE_COMPARATOR

Sleep Compression

Intervention Type 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.

Interventions

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Sleep Restriction

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.

Intervention Type BEHAVIORAL

Sleep Compression

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.

Intervention Type BEHAVIORAL

Additional CBT-i components

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Viktor Kaldo

Research Group Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanna Jernelöv, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 40205789 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33813233 (View on PubMed)

Other Identifiers

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2016/44-31/4

Identifier Type: -

Identifier Source: org_study_id

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