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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00620789 |
This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral Insomnia Therapy when used in isolation or in combination with antidepressant medication (escitalopram) among patients with Major depressive disorder and insomnia.
Condition | Intervention |
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Insomnia Major Depressive Disorder |
Drug: Escitalopram + CBT-I Behavioral: CBT-I plus placebo antidepressant medication Drug: Escitalopram |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Behavioral Insomnia Therapy For Those With Insomnia and Depression |
Estimated Enrollment: | 477 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Cognitive-Behavior Therapy for insomnia (CBT-I) + Antidepressant medication
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Drug: Escitalopram + CBT-I
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2: Placebo Comparator
Cognitive Behavior Therapy for Insomnia (CBT-I) + placebo medication
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Behavioral: CBT-I plus placebo antidepressant medication
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3: Sham Comparator
Antidepressant medication + Sleep Hygiene Control (SH)
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Drug: Escitalopram
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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.
Hypothesis I asserts that the combined CBT-I+AD therapy will produce significantly greater pre-to-post therapy improvements in sleep continuity measures than will the 2 mono-therapy conditions. The primary outcomes for these hypotheses are subjective (sleep diary) measures of TWT and SE. These sleep measures are recorded daily for 2-week periods at baseline, post-treatment, and the 6-month follow-up. The daily measures will be averaged over each 2-week period. As a result, patients will have three repeated outcomes for each of the two sleep measures: one representing the average at baseline, one for the average at post-treatment, and one for the average at 6-months. Sleep diary estimates of TWT and SE from pre to post treatment will serve as the primary measures to test this hypothesis. Our secondary outcome measures include diary estimates of total sleep time (TST), as well as objective measures of TWT, SE, & TST taken from pre-and post-treatment PSG and actigraphic monitoring We will use a 3 (treatment groups) x 2 (Baseline vs. post-treatment) Analysis of Variance (ANOVA) model to compare the performance of our treatment conditions across the primary and secondary outcomes. Treatment comparisons of CBT-I + AD vs. each of the other 2 treatments will be made. Alpha for the 2 primary outcomes is fixed at 0.025 (= 0.05/2). Further analyses will adjust for pre-treatment stratification variables and other covariates. We will, in particular, be mindful of the treatment adherence and credibility data we collect and use these measures as covariates if we find differential adherence or credibility rates across treatment conditions. In addition, we will explore the effect of changes in medication on the observed changes in our outcome measures by considering medication usage data derived from the MQS106.
Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Colleen Carney, PhD. | 919681-8788 | colleen.carney@duke.edu |
Contact: Pam Smith | 919-681-0934 | smith288@mc.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Colleen Carney, PhD 919-681-8730 colleen.carney@duke.edu | |
Contact: Pamela Smith 919-681-0934 smith288@mc.duke.edu |
Principal Investigator: | Colleen Carney, PhD | Licensed, North Carolina Psychology Board, Ontario Psychological Association, Association for Behavioral and Cognative Therapies, ABCT Insomnia and other Sleep Disorders Special Interest Group, Sleep Research Society, American Academy of Sleep Medicine |
Responsible Party: | Duke University Health System ( Colleen Carney, PhD ) |
Study ID Numbers: | Pro00003416, 1R01MH076856-01A2 |
Study First Received: | February 12, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00620789 |
Health Authority: | United States: Institutional Review Board |
Insomnia Depression |
Sleep Initiation and Maintenance Disorders Depression Sleep Disorders Dyssomnias Depressive Disorder, Major Depressive Disorder Citalopram |
Serotonin Behavioral Symptoms Sleep Disorders, Intrinsic Mental Disorders Mood Disorders Dexetimide |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |