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

Not Applicable

Completed

• Conditions: Hypnotic; Sleep Disorder
• Interventions: Other: self-help book; Other: sleep hygiene advice

• Registration Number: NCT05069285
• Lead Sponsor: University of Bergen

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.

Study Timeline

• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-06
• Study Start: 2023-05-10
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

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

Exclusion Criteria

• Below 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-help book	self-help book	A self-help book for insomnia (written in Norwegian)
Sleep hygiene advice	sleep hygiene advice	A sheet of paper with standard sleep hygiene advice

Primary Outcome Measures

Name	Time	Method
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
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 Bergen Insomnia Scale	3-6 months	Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep

Trial Locations

Locations (1)

University of Bergen; 🇳🇴 Bergen, Vestland, Norway