Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00255905

Purpose

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	Intervention
Depression	Behavioral: Cognitive behavioral therapy (CBT) for insomnia Behavioral: Clinician monitoring

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Is Insomnia a Modifiable Risk Factor for Major Depressive Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Treatment outcome of patients receiving CBT compared to clinician monitoring

Secondary Outcome Measures:

Association between rapid eye movement (REM) latency and treatment outcome

Estimated Enrollment:	45
Study Start Date:	July 2004
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255905

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Michael Perlis, PhD	University of Rochester Sleep Research Lab
Principal Investigator:	Michael Privitera, MD	Department of Psychiatry, University of Rochester

More Information

Click here for more information about the University of Rochester Sleep Research Laboratory's public Web page This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	R21 MH67184, DATR A2-AID
Study First Received:	November 16, 2005
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00255905
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Depression
Insomnia

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009