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

Insomnia Clinical Trial

— CompRest  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743338
• Other study ID #: 2016/44-31/4
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2020

Study information

• Verified date: September 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Polysomnography	Ambulatory objective sleep stage and sleep timing measure	One week before treatment (Week -1) and at week 1, week 3, week 5, and week 10
Primary	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	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)
Secondary	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)
Secondary	Adverse Events	Self-report questionnaires and interviews	Week 2, week 4 and week 5
Secondary	Sleep Problems Acceptance Questionnaire		Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks