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

Study Overview
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Sleep Restriction
* Behavioral: Sleep Compression
* Behavioral: Additional CBT-i components


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Restriction followed by additional CBT-i components<br>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<br>* 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.<br>Behavioral: Additional CBT-i components<br>* 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.<br>|
| Active Comparator: Sleep Compression followed by additional CBT-i components<br>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<br>* 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.<br>Behavioral: Additional CBT-i components<br>* 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.<br>|
| Active Comparator: Sleep Restriction followed by no intervention<br>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<br>* 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.<br>|
| Active Comparator: Sleep Compression followed by no intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10) | 
| Adverse Events | Self-report questionnaires and interviews | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Restriction, Sleep Compression, Cognitive Behavioral Therapy