Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care (AW3)
This project will test the efficacy of a brief, 2 session behavioral intervention for insomnia, as compared to an information-only condition. We hypothesize that compared to those receiving the information-only intervention, those assigned to BBTI will have superior short-term outcomes and retain the gains made, at 12 months.
We will also compare older insomniacs to age matched good sleepers through measurers of mental and physical health, sleep, and general functioning. We hypothesize that the insomnia cohort will have more physical and mental health disorders of a greater severity than the age-matched controls.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care|
- Short-term outcome will be assessed by administration of the AgeWise battery of assessments (Agebat) and polysomnographic evaluations pre and post intervention. [ Time Frame: Short-term outcome is assessed 4 weeks after intervention begins. ] [ Designated as safety issue: No ]
- Durability of BBTI will be evaluated by readministration of the clinical portions of the Agebat at six months, and both the clinical and polysomnographic evaluations at twelve months. [ Time Frame: 6 months and 12 months after the start of the intervention ] [ Designated as safety issue: No ]
- We will evaluate the effects of physical and mental health on sleep during the initial evaluation. We will also determine how physical and mental health affects response to the specific sleep interventions at week 4, and 6 and 12 months. [ Time Frame: Week 4, 6 months, 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Behavioral: Brief Behavioral Treatment of Insomnia or Information
The behavioral treatment involves education about sleep and its disorders; habits that help and hurt sleep; and recommendations about sleep hours and time in bed. It involves two meetings with a nurse who is part of the research team.
In the information condition, participants are given similar information in printed brochures that are published by the American Academy of Sleep Medicine. They are instructed to read the information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177203
|United States, Pennsylvania|
|University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Daniel J Buysse, M.D.||University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic|