Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients

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 Overview

• Status: Completed
• Conditions: Chronic Pain; Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

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 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Neurophysiology and Sleep Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2; Control Group
Experimental: 1; CBT-1	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine and confirm "prospectively" the severity and frequency of the subjects sleep complaints and as baseline data.	8 weeks

Collaborators and Investigators

• Sponsor: National Institute of Nursing Research (NINR)
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Michael Perlis, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: August 19, 2005
• First Submitted That Met QC Criteria: August 19, 2005
• First Posted (Estimate): August 23, 2005

Study Record Updates

• Last Update Posted (Estimate): January 16, 2009
• Last Update Submitted That Met QC Criteria: January 15, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 9080; 5R21NR009080-02 (U.S. NIH Grant/Contract)