BEHAVIORAL INSOMNIA THERAPY FOR THOSE WITH INSOMNIA AND DEPRESSION -
Principal Investigator/Program Director (Last, first, middle): Carney, Colleen
RESEARCH & RELATED Other Project Information
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1.a. If YES to Human Subjects
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Human Subject Assurance Number 00009025
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2.a. If YES to Vertebrate Animals
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included in the application?
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the environment?
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5.a.* Does this project involve activities outside the U.S. or m Yes l No
partnership with International Collaborators?
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Tracking Number: Other Information Page 5 OMB Number: 4040-0001
Expiration Date: 04/30/2008
Principal Investigator/Program Director (Last, first, middle): Carney, Colleen
Major depressive disorder (MDD) is a highly prevalent and debilitating condition that reduces quality of life,
increases health care utilization, markedly impairs social/occupational functioning, and enhances suicide risk
for countless individuals worldwide. A substantial proportion of MDD patients present with comorbid insomnia
that significantly complicates their clinical management. For many such patients, insomnia represents a
longstanding and problematic condition that predates the onset of MDD, adds to their suicide risk, dampens
their response to traditional depression treatment, and enhances the likelihood for MDD relapse. Moreover,
many patients who show remission of depressive symptoms with traditional therapies (e.g., antidepressant
medications, cognitive therapy) suffer from residual insomnia that increases their chances for eventual relapse.
Despite the deleterious effects insomnia may have on MDD patients, there has been surprisingly little research
to test effective insomnia management strategies among this patient group. Some reports suggest that
depression treatments may benefit from adding a hypnotic medication to traditional depression therapy, but
this approach has it limits since sleep improvements achieved with hypnotics do not endure after hypnotic
discontinuation. Cognitive-Behavioral Insomnia Therapy (CBT-I) represents a promising alternative treatment
for MDD since it is highly effective and produces sleep improvements that persist well beyond the
discontinuation of acute therapy. Unfortunately CBT-I has yet to be tested among MDD patients with comorbid
insomnia. In the current project, we will conduct a randomized clinical trial to test the efficacy of CBT-I when
used in isolation or in combination with antidepressant medication (escitalopram) among MDD patients with
comorbid insomnia. A sample of 201 patients with MDD and comorbid insomnia will be randomized to
treatments consisting of the combination of antidepressant medication plus CBT-I, antidepressant medication
plus placebo behavioral insomnia therapy, or CBT-I plus a placebo medication. Objective (polysomnography,
actigraph) and subjective (sleep diary, questionnaires) sleep measures, as well as depression and quality of
life measures will be obtained before therapy, after an 8-week treatment phase, and at 6-months follow-up.
Results of this trial will provide important new information about the short and long-term management of those
highly challenging and difficult to treat patients with insomnia comorbid to MDD.
Project Description Page 6
