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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2022
• Main ID: NCT02743338
• Date of registration: 12/04/2016
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institutet
• Public title: CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia CompRest
• Scientific title: CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia
• Date of first enrolment: July 2016
• Target sample size: 234
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02743338
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Susanna Jernelöv, PhD
• Affiliation: Karolinska Institutet

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Insomnia

Intervention(s)

Behavioral: Sleep Compression

Behavioral: Additional CBT-i components

Behavioral: Sleep Restriction

Primary Outcome(s)

Insomnia Severity Index (ISI) [Time Frame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks]

Secondary Outcome(s)

Sleep diary [Time Frame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)]

Adverse Events [Time Frame: Week 2, week 4 and week 5]

Actigraphy [Time Frame: Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10)]

Sleep Problems Acceptance Questionnaire [Time Frame: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks]

Secondary ID(s)

2016/44-31/4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors