Expired Study
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Rochester, New York 14642


Purpose:

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.


Study summary:

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 subject's 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 sleep/pain 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.


Criteria:

Inclusion Criteria: - Ages eligible for Study: Over 25 years of age - Chronic pain (>6 months) in the neck and back that has been diagnosed by a physician - Insomnia (>30 minutes to get to sleep, >30 minutes wake during the night and daytime loss of function due to insomnia and pain) Exclusion Criteria: - Unstable medical problems - Currently undergoing surgery or procedures for their pain or medical problems - Head injuries - Seizure disorders - Taking sleeping pills


Study is Available At:


Original ID:

9080


NCT ID:

NCT00133601


Secondary ID:

5R21NR009080-02


Study Acronym:


Brief Title:

Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients


Official Title:

Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

25 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Nursing Research (NINR)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Perlis, PhD
Principal Investigator
University of Rochester

Study Dates

Start Date:October 2004
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:July 2007
Primary Completion Type:Actual
Verification Date:January 2009
Last Changed Date:January 15, 2009
First Received Date:August 19, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:To determine and confirm "prospectively" the severity and frequency of the subjects sleep complaints and as baseline data.
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Behavioral Therapy
Description:CBT-I including sleep restriction, stimulus control, sleep hygiene instructions and one session of cognitive therapy devoted to catastrophic thoughts about the consequences of insomnia.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:CBT-1
Study Arm Type:No Intervention
Arm Name:2
Description:Control Group

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Nursing Research (NINR)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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