Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT00255905

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2004

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

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