Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial.
Abstract
BACKGROUND: Chronic insomnia is a prevalent disorder associated with significant psychosocial,
health, and economic impacts. Cognitive behavioral therapies (CBTs) and benzodiazepine
receptor agonist (BzRA) medications are the most widely supported therapeutic approaches
for insomnia management. However, few investigations have directly compared their
relative and combined benefits, and even fewer have tested the benefits of sequential
treatment for those who do not respond to initial insomnia therapy. Moreover, insomnia
treatment studies have been limited by small, highly screened study samples, fixed-dose,
and fixed-agent pharmacotherapy strategies that do not represent usual clinical practices.
This study will address these limitations. METHODS/DESIGN: This is a two-site randomized
controlled trial, which will enroll 224 adults who meet the criteria for a chronic
insomnia disorder with or without comorbid psychiatric disorders. Prospective participants
will complete clinical assessments and polysomnography and then will be randomly assigned
to first-stage therapy involving either behavioral therapy (BT) or zolpidem. Treatment
outcomes will be assessed after 6 weeks, and treatment remitters will be followed
for the next 12 months on maintenance therapy. Those not achieving remission will
be offered randomization to a second, 6-week treatment, again involving either pharmacotherapy
(zolpidem or trazodone) or psychological therapy (BT or cognitive therapy (CT)). All
participants will be re-evaluated 12 weeks after the protocol initiation and at 3-,
6-, 9-, and 12-month follow-ups. Insomnia remission, defined categorically as a score
< 8 on the Insomnia Severity Index, a patient-reported outcome, will serve as the
primary endpoint for treatment comparisons. Secondary outcomes will include sleep
parameters derived from daily sleep diaries and from polysomnography, subjective measures
of fatigue, mood, quality of life, and functional impairments; and measures of adverse
events; dropout rates; and treatment acceptability. Centrally trained therapists will
administer therapies according to manualized, albeit flexible, treatment algorithms.
DISCUSSION: This clinical trial will provide new information about optimal treatment
sequencing and will have direct implication for the development of clinical guidelines
for managing chronic insomnia with and without comorbid psychiatric conditions. TRIAL
REGISTRATION: ClinicalTrials.gov Identifier: NCT01651442 , Protocol version 4, 20
April 2011, registered 26 June 2012.
Type
Journal articleSubject
AdultAffect
Clinical Protocols
Cognitive Therapy
Colorado
Combined Modality Therapy
Comorbidity
Female
Humans
Hypnotics and Sedatives
Male
Mental Disorders
North Carolina
Polysomnography
Pyridines
Quality of Life
Quebec
Research Design
Sleep
Sleep Initiation and Maintenance Disorders
Surveys and Questionnaires
Time Factors
Trazodone
Treatment Outcome
Young Adult
Permalink
https://hdl.handle.net/10161/12569Published Version (Please cite this version)
10.1186/s13063-016-1242-3Publication Info
Morin, Charles M; Edinger, Jack D; Krystal, Andrew D; Buysse, Daniel J; Beaulieu-Bonneau,
Simon; & Ivers, Hans (2016). Sequential psychological and pharmacological therapies for comorbid and primary insomnia:
study protocol for a randomized controlled trial. Trials, 17(1). pp. 118. 10.1186/s13063-016-1242-3. Retrieved from https://hdl.handle.net/10161/12569.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
Andrew Darrell Krystal
Professor Emeritus of Psychiatry and Behavioral Sciences
My research is focused on better understanding the pathophysiology of sleep disorders
and mood disorders and developing improved treatments for these conditions. My primary
research tools are: electroencepahlography (EEG), polysomnography (PSG), computer
signal analysis and modeling, functional magnetic resonance imaging (fMRI), and positron
emission tomograophy (PET). Nearly all of my projects have been carried out with
humans, however, projects are ongoing with gene knock-out models in

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info