Clincosm LogoSign in Get a demo

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

Sponsor
University of Bergen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069285
Collaborator
(none)
150
Enrollment
2
Arms
16
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: self-help book
  • Other: sleep hygiene advice
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Use of hypnotics assessed as days per week [3-6 months]

    Self-reported sleep medication use (days of use per week,0-7)

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Bergen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bjorn Bjorvatn, Professor, University of Bergen
ClinicalTrials.gov Identifier:
NCT05069285
Other Study ID Numbers:
  • PraksisNettRCT2022
First Posted:
Oct 6, 2021
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sleep Wake Disorders

Study Results

No Results Posted as of May 19, 2022