Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care
Completed · Not applicable
Conditions studied: Insomnia
In brief
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.
Key facts
- Study ID
- NCT00177203
- Run by
- University of Pittsburgh
- People needed
- 140
- Starts
- 2003-06-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2015-05-28
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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