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

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sleep Restriction
Sleep Compression
Additional CBT-i components
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Sleep Restriction, Sleep Compression, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sleep Restriction followed by additional CBT-i components

Sleep Compression followed by additional CBT-i components

Sleep Restriction followed by no intervention

Sleep Compression followed by no intervention

Arm Description

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 treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Adverse Events
Self-report questionnaires and interviews
Sleep Problems Acceptance Questionnaire

Full Information

First Posted
April 12, 2016
Last Updated
September 8, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02743338
Brief Title
CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia
Acronym
CompRest
Official Title
CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Sleep Restriction, Sleep Compression, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Restriction followed by additional CBT-i components
Arm Type
Experimental
Arm Description
Sleep Restriction treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.
Arm Title
Sleep Compression followed by additional CBT-i components
Arm Type
Active Comparator
Arm Description
Sleep Compression treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.
Arm Title
Sleep Restriction followed by no intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sleep Compression followed by no intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Restriction
Intervention Description
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
Intervention Name(s)
Sleep Compression
Intervention Description
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
Intervention Name(s)
Additional CBT-i components
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Secondary Outcome Measure Information:
Title
Sleep diary
Description
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
Time Frame
Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Title
Actigraphy
Description
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
Time Frame
Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
Title
Adverse Events
Description
Self-report questionnaires and interviews
Time Frame
Week 2, week 4 and week 5
Title
Sleep Problems Acceptance Questionnaire
Time Frame
Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Other Pre-specified Outcome Measures:
Title
Polysomnography
Description
Ambulatory objective sleep stage and sleep timing measure
Time Frame
One week before treatment (Week -1) and at week 1, week 3, week 5, and week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Jernelöv, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33813233
Citation
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.
Results Reference
derived

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

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