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

NCT02743338 | Completed

• 1 other identifier: 2016/44-31/4
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Sleep Restriction; Sleep Compression; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Sleep diary

  Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)

• Actigraphy

  Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)

• Adverse Events

  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

Other Outcomes (1)

• Polysomnography

  One week before treatment (Week -1) and at week 1, week 3, week 5, and week 10

Study Arms (4)

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.

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.

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.

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.

Behavioral: Sleep Compression

Interventions

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.

Sleep Restriction followed by additional CBT-i components; Sleep Restriction followed by no intervention

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.

Sleep Compression followed by additional CBT-i components; Sleep Compression followed by no intervention

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.

Sleep Compression followed by additional CBT-i components; Sleep Restriction followed by additional CBT-i components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Stockholm, 14186, Sweden

Location

Related Publications (2)

• 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.

  PMID: 40205789 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.

  PMID: 33813233 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Susanna Jernelöv, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Group Leader

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 19, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

SE (1)