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Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT) for insomnia
Clinician monitoring
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression, Insomnia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Rochester Sleep and Neurophysiology Research Lab

Outcomes

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

Full Information

First Posted
November 16, 2005
Last Updated
June 27, 2013
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00255905
Brief Title
Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia
Official Title
Is Insomnia a Modifiable Risk Factor for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Insomnia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT) for insomnia
Intervention Type
Behavioral
Intervention Name(s)
Clinician monitoring
Primary Outcome Measure Information:
Title
Treatment outcome of patients receiving CBT compared to clinician monitoring
Secondary Outcome Measure Information:
Title
Association between rapid eye movement (REM) latency and treatment outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Perlis, PhD
Organizational Affiliation
University of Rochester Sleep Research Lab
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Privitera, MD
Organizational Affiliation
Department of Psychiatry, University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Sleep and Neurophysiology Research Lab
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15283007
Citation
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. doi: 10.1093/sleep/27.4.715.
Results Reference
background
PubMed Identifier
11772681
Citation
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. doi: 10.1176/appi.ajp.159.1.5.
Results Reference
background
Links:
URL
http://www.sleeplessinrochester.com
Description
Click here for more information about the University of Rochester Sleep Research Laboratory's public Web page

Learn more about this trial

Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia

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