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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial

Authors: Kim Dekker, Jeroen S. Benjamins, Annemieke Van Straten, Winni F. Hofman, Eus J. W. Van Someren

Published in: Trials | Issue 1/2015

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Abstract

Background

DSM-V criteria for insomnia disorder are met by 6 to 10 % of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses.
The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following:
1.
The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming;
 
2.
Whether the effectiveness of internet-supported cognitive behavioral therapy for insomnia can be augmented by simultaneous or prior application of bright light, physical activity and body warming; and
 
3.
Whether the effectiveness of the interventions and their combination are moderated by the insomnia subtype.
 

Methods/Design

In a repeated measures, placebo-controlled, randomized clinical trial that included 160 people diagnosed with insomnia disorder, we are evaluating the relative effectiveness of 4 intervention weeks. Primary outcome is subjective sleep efficiency, quantified using a sleep diary. Secondary outcomes include other complaints of sleep and daytime functioning, health-related cost estimates and actigraphic objective sleep estimates. Compliance will be monitored both subjectively and objectively using activity, light and temperature sensors. Insomnia subtypes will be assessed using questionnaires. Mixed effect models will be used to evaluate intervention effects and moderation by insomnia subtype ratings.

Discussion

The current study addresses multiple opportunities to optimize and personalize treatment of insomnia disorder.

Trial registration

Netherlands National Trial Register NTR4010, 4 June 2013.
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Metadata
Title
Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial
Authors
Kim Dekker
Jeroen S. Benjamins
Annemieke Van Straten
Winni F. Hofman
Eus J. W. Van Someren
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0790-2

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