Sequenced Therapies for Comorbid and Primary Insomnias
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
Chronic insomnia is a prevalent disorder associated with increased health care costs,
impaired functioning, and an increased risk for developing serious psychiatric disorders.
Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications
are the most widely supported approaches for insomnia management. Unfortunately, few studies
have compared the psychological/behavioral therapies and BzRAs for insomnia treatment.
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
adjustable dosing practices, relatively short follow-up intervals, and reliance on
self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more
clinically relevant indicators of remission. Finally, studies have yet to test the benefits
of treatment sequencing for those who do not respond to initial their insomnia therapy. This
multi-site project will address these limitations. Two study sites will enroll a total of 224
participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion
(60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder.
Participants will be evaluated with clinical assessments and PSG, and then will be randomly
assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT)
or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer
therapies according to manualized, albeit flexible, treatment algorithms. Initial 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 re-randomization
to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or
psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12
weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing
their final treatment. Insomnia remission, defined categorically as a score < 8 on the
Insomnia Severity Index, will serve as the primary outcome for treatment comparisons.
Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of
sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our
over-arching goal is to obtain new information that aids in the development of clinical
guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.
Phase:
N/A
Details
Lead Sponsor:
Jack Edinger, PhD
Collaborators:
National Institute of Mental Health (NIMH) National Institutes of Health (NIH)