Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255905
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : June 28, 2013
National Institute of Mental Health (NIMH)
Information provided by:
University of Rochester

November 16, 2005
November 21, 2005
June 28, 2013
July 2004
July 2007   (Final data collection date for primary outcome measure)
Treatment outcome of patients receiving CBT compared to clinician monitoring
Same as current
Complete list of historical versions of study NCT00255905 on Archive Site
Association between rapid eye movement (REM) latency and treatment outcome
Same as current
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Not Provided
Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia
Is Insomnia a Modifiable Risk Factor for Major Depressive Disorder
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating insomnia symptoms that are secondary to depression. This study will also determine how long the benefits of CBT will last and how the recurrence of insomnia is associated with the onset of new depressive episodes.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
  • Behavioral: Cognitive behavioral therapy (CBT) for insomnia
  • Behavioral: Clinician monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2007
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R21MH067184( U.S. NIH Grant/Contract )
R21MH067184 ( U.S. NIH Grant/Contract )
Not Provided
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University of Rochester
National Institute of Mental Health (NIMH)
Principal Investigator: Michael Perlis, PhD University of Rochester Sleep Research Lab
Principal Investigator: Michael Privitera, MD Department of Psychiatry, University of Rochester
University of Rochester
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP