Hypnotic; Sleep Disorder
Conditions
Brief summary
The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.
Detailed description
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia compared to the effect of sleep hygiene advice in patients using sleep medications. 150 patients will be randomized to receive either the book (75 patients) or the sleep hygiene advice (75 patients). Patients will fill questionnaires about sleep and health problems at baseline and after 3-6 months after receiving the written material. The main aims are to assess whether a self-help book is more effective in reducing sleep medication use and sleep problems.
Interventions
OTHERsleep hygiene advice
information and advice given on the sheet of paper with sleep hygiene
OTHERself-help book
information and advice given in the self-help book
Sponsors
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Use of sleep medications on prescription or OTC during the last 6 months
Exclusion criteria
\- Below 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of hypnotics assessed as days per week | 3-6 months | Self-reported sleep medication use (days of use per week,0-7) |
| Insomnia severity assessed with Insomnia Severity Index | 3-6 months | Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep |
| Insomnia severity assessed with Bergen Insomnia Scale | 3-6 months | Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep |
Countries
Norway
Outcome results
None listed