Pharmacological and Behavioral Treatment of Insomnia
to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae.
Sleep Initiation and Maintenance Disorders
|Study Design:||Observational Model: Natural History
Time Perspective: Longitudinal
|Study Start Date:||June 1997|
|Estimated Study Completion Date:||May 2002|
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.
|Investigator:||Gregg Jacobs||Beth Israel Deaconess Medical Center|