Clinical trial NCT02743338: CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia
Official title: CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Sleep Restriction
Sleep Compression
Cognitive Behavioral Therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Secondary outcomes:
measure: Sleep diary
timeFrame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
measure: Actigraphy
timeFrame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)
measure: Adverse Events
timeFrame: Week 2, week 4 and week 5
measure: Sleep Problems Acceptance Questionnaire
timeFrame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
Other outcomes:
measure: Polysomnography
timeFrame: One week before treatment (Week -1) and at week 1, week 3, week 5, and week 10
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
Study officials:
affiliation: Karolinska Institutet
name: Susanna Jernelöv, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.