Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133601
• Other study ID #: 9080
• Secondary ID: 5R21NR009080-02
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2005
• Last updated: January 15, 2009
• Start date: October 2004
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia

Intervention

Behavioral:
• Cognitive Behavioral Therapy
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.

Locations

Country	Name	City	State
United States	University of Rochester Neurophysiology and Sleep Research Laboratory	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine and confirm "prospectively" the severity and frequency of the subjects sleep complaints and as baseline data.		8 weeks	No