Sleep Disorders |
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Clinical Trial: Pharmacological and Behavioral Treatment of Insomnia
This study has been completed.
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 |
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| Lung Diseases Sleep Sleep Initiation and Maintenance Disorders |
MedlinePlus related topics: Respiratory Diseases; Sleep Disorders
Study Type: Observational
Study Design: Natural History, Longitudinal
Study start: June 1997; Study completion: May 2002
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
Location Information
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.
Record last reviewed: February 2005
Last Updated: February 17, 2005
Record first received: May 25, 2000
ClinicalTrials.gov Identifier: NCT00005753
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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