Pharmacological and Behavioral Treatment of Insomnia

This study has been completed.

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00005753

First received: May 25, 2000

Last updated: June 23, 2005

Last verified: February 2005

History of Changes

Purpose

to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae.

Condition
Lung Diseases Sleep Sleep Initiation and Maintenance Disorders

Study Type:	Observational
Study Design:	Observational Model: Natural History Time Perspective: Longitudinal

Resource links provided by NLM:

MedlinePlus related topics: Insomnia

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	June 1997
Estimated Study Completion Date:	May 2002

Detailed Description:

DESIGN NARRATIVE:

The study examined the relative efficacy of a pharmacologic, cognitive behavioral, and conjoint pharmacological/behavioral intervention for chronic sleep-onset insomnia. Sixty-three medication-free, chronic sleep-onset insomniacs completed evaluations, baseline sleep diaries, daytime functioning and mood inventories and home-based objective sleep assessments (OSA). Subjects were then randomized to one of four interventions: 1) six week Zolpidem intervention (D for drug); 2) six week multifactor behavioral intervention (B for behavioral); 3) six week conjoint Zolpidem and multifactor behavioral intervention (DB); and 4) placebo medication intervention (P for placebo). The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005753

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Gregg Jacobs

Beth Israel Deaconess Medical Center

More Information

Publications:

Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med. 2004 Sep 27;164(17):1888-96.

ClinicalTrials.gov Identifier:	NCT00005753 History of Changes
Other Study ID Numbers:	5100
Study First Received:	May 25, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Lung Diseases
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Mental Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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