Back to resultsA Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications
Primary Purpose
Hypnotic; Sleep Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
self-help book
sleep hygiene advice
Sponsored by
About this trial
This is an interventional treatment trial for Hypnotic; Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- Use of sleep medications on prescription or OTC during the last 6 months
Exclusion Criteria:
- Below 18 years of age
Sites / Locations
- University of BergenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self-help book
Sleep hygiene advice
Arm Description
A self-help book for insomnia (written in Norwegian)
A sheet of paper with standard sleep hygiene advice
Outcomes
Primary Outcome Measures
Use of hypnotics assessed as days per week
Self-reported sleep medication use (days of use per week,0-7)
Insomnia severity assessed with Insomnia Severity Index
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
Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05069285
Brief Title
A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications
Official Title
A Randomized Controlled Trial Comparing a Self-help Book Focusing on Cognitive Behavioral Therapy for Insomnia With Standard Sleep Hygiene Advice Among Patients Using Hypnotics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypnotic; Sleep Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-help book
Arm Type
Experimental
Arm Description
A self-help book for insomnia (written in Norwegian)
Arm Title
Sleep hygiene advice
Arm Type
Active Comparator
Arm Description
A sheet of paper with standard sleep hygiene advice
Intervention Type
Other
Intervention Name(s)
self-help book
Intervention Description
information and advice given in the self-help book
Intervention Type
Other
Intervention Name(s)
sleep hygiene advice
Intervention Description
information and advice given on the sheet of paper with sleep hygiene
Primary Outcome Measure Information:
Title
Use of hypnotics assessed as days per week
Description
Self-reported sleep medication use (days of use per week,0-7)
Time Frame
3-6 months
Title
Insomnia severity assessed with Insomnia Severity Index
Description
Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep
Time Frame
3-6 months
Title
Insomnia severity assessed with Bergen Insomnia Scale
Description
Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Use of sleep medications on prescription or OTC during the last 6 months
Exclusion Criteria:
- Below 18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørn Bjorvatn, MD PhD
Phone
4755586088
Email
bjorn.bjorvatn@uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Bjorvatn, MD PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Vestland
ZIP/Postal Code
5019
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjørn Bjorvatn, MD PhD
Phone
+4791140269
Email
bjorn.bjorvatn@uib.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications
We'll reach out to this number within 24 hrs