Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133601
Status:
COMPLETED
Last Update Posted:
2009-01-16
First Post:
2005-08-19
Brief Title:
Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institute of Nursing Research NINR
Study Overview
Official Title:
Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients
Status:
COMPLETED
Status Verified Date:
2009-01
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 of cognitive behavioral therapy for insomnia in chronic pain patients is a randomized controlled clinical trial of parallel groups with three and six months follow up
Detailed Description:
Forty five subjects both male and female of diverse racial backgrounds ages 25 with insomnia secondary to pain will be recruited from the Pain Clinic at URMC and from the community at large via advertisements and solicited primary care referrals to participate in a parallel-groups randomized single blind controlled trial Protocol eligible subjects as determined via a phone screen interview or by responses to our web based screening questionnaire will be evaluated in-lab The screen will determine whether subjects have chronic insomnia secondary to pain and do not meet any of the exclusion criteria Once found to be study eligible they are given an appointment for the reading and signing of the consent and the intake interview The in-lab intake interview includes the administration of a broad battery of self-report instruments Following the clinical interview subjects will undergo a physical exam The history to include drug and ETOH use and physical examination will include blood and urine chemistries to rule out any acute or unstable medical co-morbidity including pregnancy The lab work will include profiles to assess renal liver thyroid and anemia as well as urine toxicology screen for illicit drug use The lab work results will be reviewed by the Co-PI and our medical consultant If significant abnormal findings are discovered the subject will be referred to their primary care provider for treatment In addition to conducting an in-house physical after the subject signs a release of information the researchers also FAX the prospective subjects primary care physician a letter asking them to confirm that the individual is eligible for the study
If data from both these evaluations suggest that the subject is protocol eligible according to the inclusion and exclusion criteria the subject is asked to fill out two weeks of sleeppain diaries The diary data are used to prospectively confirm the severity and frequency of the subjects sleep complaints and as baseline data Finally all subjects will be evaluated by polysomnography PSG to assure that they do not have an occult sleep disorder Once determined to be study appropriate the subjects will be randomized into a treatment group They will see the therapist weekly for 8 weeks At 3 month and 6 month intervals after weekly therapy session end the subject will be asked to fill out sleep diaries and wear an actiwatch for a period of two weeks
If data from both these evaluations suggest that the subject is protocol eligible according to the inclusion and exclusion criteria the subject is asked to fill out two weeks of sleeppain diaries The diary data are used to prospectively confirm the severity and frequency of the subjects sleep complaints and as baseline data Finally all subjects will be evaluated by polysomnography PSG to assure that they do not have an occult sleep disorder Once determined to be study appropriate the subjects will be randomized into a treatment group They will see the therapist weekly for 8 weeks At 3 month and 6 month intervals after weekly therapy session end the subject will be asked to fill out sleep diaries and wear an actiwatch for a period of two weeks
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 |
|---|---|---|---|
| 5R21NR009080-02 | NIH | None | httpsreporternihgovquickSearch5R21NR009080-02 |