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

Karolinska Institute

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Additional CBT-i components; Behavioral: Sleep Compression; Behavioral: Sleep Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT02743338

2016/44-31/4

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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234 participants in 4 patient groups

Sleep Restriction followed by additional CBT-i components

Experimental group

Description:

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

Treatment:

Behavioral: Additional CBT-i components

Behavioral: Sleep Restriction

Sleep Compression followed by additional CBT-i components

Active Comparator group

Description:

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

Treatment:

Behavioral: Additional CBT-i components

Behavioral: Sleep Compression

Sleep Restriction followed by no intervention

Active Comparator group

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.

Treatment:

Behavioral: Sleep Restriction

Sleep Compression followed by no intervention

Active Comparator group

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.

Treatment:

Behavioral: Sleep Compression