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Completed

NCT Number: NCT02743338

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Stockholm, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sleep diary

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

    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

  2. Actigraphy

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

    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

  3. Adverse Events

    Time frame: Week 2, week 4 and week 5

    Self-report questionnaires and interviews

  4. Sleep Problems Acceptance Questionnaire

    Time frame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks

Other outcomes

  1. Polysomnography

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

    Ambulatory objective sleep stage and sleep timing measure

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia

Acronym: CompRest

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2016
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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