Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042146
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2002-07-24
Brief Title:
Behavioral and Pharmacological Treatment for Insomnia
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Behavioral and Pharmacological Treatment for Insomnia
Status:
COMPLETED
Status Verified Date:
2013-05
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:
None
Brief Summary:
This study will evaluate the long- and short-term effects of cognitive-behavior therapy CBT alone and in combination with zolpidem Ambien for chronic insomnia
Detailed Description:
Insomnia is a prevalent health concern which is often associated with functional impairments reduced quality of life and increased health-care costs The proposed study may provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia
Participants are randomly assigned to CBT or CBT plus medication After the 6-week acute treatment phase participants enter into a 6-month extended treatment phase Of those treated with CBT alone initially responders are randomized to extended CBT or no treatment Of those receiving the combined CBT plus medication approach initially responders are randomized to an extended treatment consisting of either CBT plus medication used on an as needed schedule or CBT alone plus medication tapering Outcome is evaluated across measures of sleep clinical ratings and several indices of daytime functioning The measures are administered at baseline at the end of the acute and extended treatment phases and at 6 12 and 24-month follow-up
Participants are randomly assigned to CBT or CBT plus medication After the 6-week acute treatment phase participants enter into a 6-month extended treatment phase Of those treated with CBT alone initially responders are randomized to extended CBT or no treatment Of those receiving the combined CBT plus medication approach initially responders are randomized to an extended treatment consisting of either CBT plus medication used on an as needed schedule or CBT alone plus medication tapering Outcome is evaluated across measures of sleep clinical ratings and several indices of daytime functioning The measures are administered at baseline at the end of the acute and extended treatment phases and at 6 12 and 24-month follow-up
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A4-GPS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060413 |
| R01MH060413 | NIH | None | None |