A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications

May 11, 2023 updated by: Bjorn Bjorvatn, University of Bergen

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

The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
    • Vestland
      • Bergen, Vestland, Norway, 5019
        • Recruiting
        • University of Bergen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Use of sleep medications on prescription or OTC during the last 6 months

Exclusion Criteria:

- Below 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-help book
A self-help book for insomnia (written in Norwegian)
Other: self-help book
information and advice given in the self-help book
Active Comparator: Sleep hygiene advice
A sheet of paper with standard sleep hygiene advice
Other: sleep hygiene advice
information and advice given on the sheet of paper with sleep hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of hypnotics assessed as days per week
Time Frame: 3-6 months
Self-reported sleep medication use (days of use per week,0-7)
3-6 months
Insomnia severity assessed with Insomnia Severity Index
Time Frame: 3-6 months
Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep
3-6 months
Insomnia severity assessed with Bergen Insomnia Scale
Time Frame: 3-6 months
Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Investigators

  • Principal Investigator: Bjørn Bjorvatn, MD PhD, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PraksisNettRCT2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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