NCT00255905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

November 16, 2005

Last Update Submit

June 27, 2013

Conditions

Depression

Keywords

DepressionInsomnia

Outcome Measures

Primary Outcomes (1)

  • Treatment outcome of patients receiving CBT compared to clinician monitoring

Secondary Outcomes (1)

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

Interventions

Cognitive behavioral therapy (CBT) for insomniaBEHAVIORAL
Clinician monitoringBEHAVIORAL

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Sleep and Neurophysiology Research Lab

Rochester, New York, 14642, United States

Location

Related Publications (2)

  • 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.

    PMID: 15283007BACKGROUND

  • 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.

    PMID: 11772681BACKGROUND

MeSH Terms

Conditions

DepressionSleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Perlis, PhD

    University of Rochester Sleep Research Lab

    PRINCIPAL INVESTIGATOR

  • Michael Privitera, MD

    Department of Psychiatry, University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

US(1)