Effectiveness of internet-supported cognitive behavioral and chronobiological
interventions and effect moderation by insomnia subtype: study protocol of a
randomized controlled trial.
Author(s): Dekker K(1), Benjamins JS(2), Van Straten A(3), Hofman WF(4,)(5), Van Someren
EJ(6,)(7).
Affiliation(s): Author information:
(1)Netherlands Institute for Neuroscience, An Institute of the Royal Netherlands
Academy of Arts and Sciences, Meibergdreef 47, 1105 BA, Amsterdam, The
Netherlands. k.dekker@nin.knaw.nl. (2)Department of Clinical and Health
Psychology, Department of Experimental Psychology, Utrecht University,
Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands. j.s.benjamins@uu.nl.
(3)Department of Clinical Psychology, VU University Amsterdam & EMGO Institute
for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The
Netherlands. a.van.straten@vu.nl. (4)Department of Psychology, Brain and
Cognition group, University of Amsterdamy, Weesperplein 4, 1018 XA, Amsterdam,
The Netherlands. w.f.hofman@uva.nl. (5)Personal Health Institute International,
Lobo-Braakensiekstraat 94, 1065 HP, Amsterdam, The Netherlands.
w.f.hofman@uva.nl. (6)Netherlands Institute for Neuroscience, An Institute of the
Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, 1105 BA,
Amsterdam, The Netherlands. e.van.someren@nin.knaw.nl. (7)Departments of
Integrative Neurophysiology and Medical Psychology, Center for Neurogenomics and
Cognitive Research (CNCR), Neuroscience Campus Amsterdam, VU University and
Medical Center, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.
e.van.someren@nin.knaw.nl.
Publication date & source: 2015, Trials. , 16:292
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.
|