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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
National Institute on Aging (NIA) |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00177203 |
Purpose
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 | Intervention |
|---|---|
|
Insomnia |
Behavioral: Brief Behavioral Treatment of Insomnia or Information |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 140 |
| Study Start Date: | June 2003 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
As a prevalent problem among the elderly, insomnia is often treated by primary care physicians, and benzodiazepine receptor agonists (BzRA) are the most widely prescribed form of treatment. Behavioral interventions offer an effective option to BzRA therapy as they are preferred by many elderly patients and have a lower side effect profile. Presently behavioral interventions are available on specialty care clinics, provided by trained therapists, requiring up to six intervention sessions. This project will test the efficacy of a brief, two sessions behavioral model which could be adapted to the primary care setting. In addition, we will compare older insomniacs to age matched good sleepers through measurers of mental and physical health, sleep and general functioning. We expect that 100 enrolled individuals age 60 or older with Insomnia and a control cohort of 50 enrolled individuals matched by age and gender will complete the study. Subjects will be randomly assigned to one of two intervention conditions: (1.) receive a two session Brief Behavioral Treatment Intervention(BBTI), or (2.) a information-only modality in which they will be encouraged to read handouts on sleep, insomnia and healthy sleep practices published by the AASM. Clinical evaluation will include the Agebat measures (common to all five projects in this Program Project) and in-home or laboratory polysomnographic measures. Sleep dairies and wrist actigraphy will be used to measure treatment adherence. Patients will be evaluated before and after completing the assigned intervention cells. Those receiving BBTI will be re-evaluated at 12 months following a six month "booster" session. Data obtained from the control cohort will include the Agebat measures. 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 also predict that the insomnia cohort will have more physical and mental health disorders of a greater severity than the age-matched controls.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Daniel J. Buysse, M.D., University of Pittsburgh, Western Psychiatric Institute & Clinic |
| ClinicalTrials.gov Identifier: | NCT00177203 History of Changes |
| Other Study ID Numbers: | 021115, AG20677-03 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 11, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Insomnia Sleep Disorders Sleeplessness Chronic Insomnia |
Sleep Studies Disorders of Initiating and Maintaining Sleep Primary Care |
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |