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Completed

NCT Number: NCT05069285

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

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

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Key information

Conditions

Hypnotic; Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Vestland, 5019, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Below 18 years of age

Treatment and study plan

self-help book

Other

information and advice given in the self-help book

Sleep Hygiene Advice

Other

information and advice given on the sheet of paper with sleep hygiene

Primary outcomes

  1. 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)

  2. 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. 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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2021
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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