The broad, long-term objective of this project is to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae. The main specific aim of this project is to examine the relative efficacy of a pharmacologic, behavioral, and conjoint pharmacological/behavioral intervention for chronic sleep-onset insomnia. Eighty medication-free, chronic sleep-onset insomniacs will complete evaluations, baseline sleep diaries, daytime functioning and mood inventories and home-based objective sleep assessments (OSA). Subjects will then be 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). All subjects will complete OSA's, sleep diaries, daytime functioning and mood inventories at posttreatment and sleep diaries at one, three, six and twelve month follow-up. It is hypothesized that, during drug administration, DB>D>B>P on improvement in sleep and mood but, after drug discontinuation, DB>B>D=P. It is also hypothesized that only the DB and B groups will show maintenance or enhancement of therapeutic gains at long-term follow-up.
| Jacobs, Gregg D; Pace-Schott, Edward F; Stickgold, Robert et al. (2004) Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med 164:1888-96 |
