Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177203
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2005-09-12
Brief Title:
Agewise Project 3 Brief Behavioral Treatment of Insomnia in Primary Care
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Agewise Project 3 Brief Behavioral Treatment of Insomnia in Primary Care
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AW3
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 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
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
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 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 InterventionBBTI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P01AG020677 | NIH | None | httpsreporternihgovquickSearch5P01AG020677 |