Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia
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.
Behavioral: Cognitive behavioral therapy (CBT) for insomnia
Behavioral: Clinician monitoring
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Is Insomnia a Modifiable Risk Factor for Major Depressive Disorder|
- Treatment outcome of patients receiving CBT compared to clinician monitoring
- Association between rapid eye movement (REM) latency and treatment outcome
|Study Start Date:||July 2004|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255905
|United States, New York|
|University of Rochester Sleep and Neurophysiology Research Lab|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Michael Perlis, PhD||University of Rochester Sleep Research Lab|
|Principal Investigator:||Michael Privitera, MD||Department of Psychiatry, University of Rochester|