Status:
COMPLETED
Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Insomnia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 inform...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age 60 or older
- Current diagnosis of Insomnia using DSM-IV criteria (Insomnia group)
- No current diagnosis of Insomnia (Control group)
- Provision of written informed consent
Exclusion
- Psychiatric: untreated depressive, anxiety, psychotic and substance use disorders and/or treated or untreated delirium of dementia. We will exclude at intake to the study any individual with moderate to severe cognitive impairment who is likely to be demented. In the event that an individual scores less than \< 25 on the Mini-Mental State Exam, we will exclude that person from the study. We will also discuss our concerns with the subject and will suggest that he or she contact the Memory Disorders Clinic run by the Alzheimer's Disease Research Center. We will give the subject literature on this Clinic as well as their phone number. We will not exclude persons with milder cognitive decrements because chronic medical disease and its associated sleep disruption are themselves associated with some impairment of cognitive performance.
- Medical: ongoing chemotherapy or radiation cancer treatment, hospitalization within the past two weeks or terminal illness with a life expectancy less than 6 months;
- Sleep: untreated obstructive sleep apnea syndrome, narcolepsy or restless legs syndrome.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00177203
Start Date
June 1 2003
End Date
January 1 2009
Last Update
May 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213