Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care (AW3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00177203|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Brief Behavioral Treatment of Insomnia or Information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- 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.Other Name: Information only
- 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. ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|