Internet-based Treatment for Insomnia

Not Applicable

Completed

• Conditions: Psychophysiologic Insomnia
• Interventions: Behavioral: CBT for insomnia SHUTi; Behavioral: passive patient education/sleep hygiene

• Registration Number: NCT02261272
• Lead Sponsor: Norwegian Institute of Public Health

Brief Summary

The study will test an internet-based treatment for insomnia.

Detailed Description

This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Primary Completion: 2016-01
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. age 18 years or older
2. fulfillment of the DMS-IV criteria for insomnia
3. duration of at least 3 months
4. complaints of impaired daytime functioning

Exclusion Criteria

1. presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
2. working night shifts and unable to discontinue this work pattern
3. having a serious somatic condition preventing further participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT for insomnia	CBT for insomnia SHUTi	Cognitive-behavioral therapy for insomnia
Sleep Hygiene	passive patient education/sleep hygiene	Psychoeducational intervention based on standard sleep hygiene advices

Primary Outcome Measures

Name	Time	Method
Insomnia symptoms	Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU	Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU

Secondary Outcome Measures

Name	Time	Method
Daytime functioning (mental health problems and fatigue)	Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU	Self-reported questionnaires
Sleep diary data	Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU	Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU

Trial Locations

Locations (1)

Norwegian Institute of Public Health; 🇳🇴 Bergen, Norway