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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive behavioral therapy (CBT) for insomnia Behavioral: Clinician monitoring Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Is Insomnia a Modifiable Risk Factor for Major Depressive Disorder
Study Start Date : July 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Treatment outcome of patients receiving CBT compared to clinician monitoring

Secondary Outcome Measures :
  1. Association between rapid eye movement (REM) latency and treatment outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255905

United States, New York
University of Rochester Sleep and Neurophysiology Research Lab
Rochester, New York, United States, 14642
Sponsors and Collaborators
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

Publications: Identifier: NCT00255905     History of Changes
Other Study ID Numbers: R21MH067184 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by University of Rochester:

Additional relevant MeSH terms:
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases