- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255905
Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia
Is Insomnia a Modifiable Risk Factor for Major Depressive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Insomnia, characterized by an inability to initiate and maintain sleep, is a defining feature of mood disorders such as depression. CBT has been found to be an effective treatment for depression-related insomnia. This study will determine the effectiveness of CBT in treating insomnia that is secondary to depression. In addition, this study will assess the relationship between insomnia and depression, since previous studies have shown that insomnia may not only be a symptom of depression but may also indicate the onset of a depressive episode.
Participants will be randomly assigned to receive weekly sessions of either CBT or clinician monitoring for 8 weeks. Participants in both groups will meet with a therapist at selected visits, but only CBT participants will receive actual therapy. All participants will have 13 study visits; four will be overnight visits in a sleep lab. On Visit 1, participants will complete questionnaires about their sleep quality and symptoms of depression. Participants will also undergo a physical exam and will begin a daily sleep diary. Visits 2, 3, 12, and 13 will be overnight visits in the sleep lab. During these visits, participants will have electrodes placed on their bodies and a polysomnograph will be used to monitor their sleep. Participants will meet with their therapist on Visits 4 to 11. Participants' sleep diaries, depression scales, and sleep scales will be used for assessment. After the intervention part of the study is complete, participants will have monthly follow-up visits for up to 2 years. During the follow-up visits, participants will complete questionnaires about their sleep quality and symptoms of depression.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Sleep and Neurophysiology Research Lab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- History of recurrent depression with the age of onset between 20 and 40 years of age
- At least one depressive episode within 2 years prior to study entry
- At least three discrete depressive episodes within 10 years prior to study entry
- Successful treatment for or resolution of last episode of depression
- Participants whose depression is in remission are eligible for study enrollment. Criteria for remission includes more than 3 consecutive weeks during which the patient does not meet DSM-IV criteria for depression; a Hamilton Rating Depression Scale score less than 6 and a Beck Depression Inventory (BDI) less than 6; no feelings of depression for at least 6 months prior to study entry; and have not taken depression medication for at least 3 months prior to study entry. Once enrolled in the study, these participants must score less than 6 on the weekly BDIs for the first 3 weeks of the study.
- Have experienced mental stability between depressive episodes
- Willing to discontinue over-the-counter or naturopathic remedies for insomnia or depression during the study
- Able to write and speak English fluently
Exclusion Criteria:
- Current use of maintenance antidepressant therapy
- History of a failure to respond to citalopram treatment
- Unstable medical or psychiatric illness other than major depressive disorder
- History of seizures or head injury
- Current substance or alcohol abuse
- Symptoms suggestive of sleep disorders other than insomnia
- Pregnancy or plan to become pregnant within 2 years of study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Treatment outcome of patients receiving CBT compared to clinician monitoring
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Secondary Outcome Measures
Outcome Measure |
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Association between rapid eye movement (REM) latency and treatment outcome
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Perlis, PhD, University of Rochester Sleep Research Lab
- Principal Investigator: Michael Privitera, MD, Department of Psychiatry, University of Rochester
Publications and helpful links
General Publications
- Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5.
- Perlis ML, Smith MT, Orff H, Enright T, Nowakowski S, Jungquist C, Plotkin K. The effects of modafinil and cognitive behavior therapy on sleep continuity in patients with primary insomnia. Sleep. 2004 Jun 15;27(4):715-25. doi: 10.1093/sleep/27.4.715.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH067184 (U.S. NIH Grant/Contract)
- DATR A2-AID (NIH Adult Translational Research and Treatment Development)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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