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Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients - Article


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Cognitive behavior therapy


Clinical Trial: Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients

This study is currently recruiting patients.
Verified by National Institute of Nursing Research (NINR) August 2005

Sponsors and Collaborators: National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00133601

Purpose

Randomized, controlled clinical trial, parallel groups with three and six months follow up.
Condition Intervention Phase
Insomnia
Chronic Pain
 Behavior: Cognitive Behavioral Therapy
Phase I

MedlinePlus related topics:  Pain;   Sleep Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment

Further Study Details: 
Primary Outcomes: To determine and confirm "prospectively" the severity and frequency of the subjects sleep complaints and as baseline data.
Expected Total Enrollment:  45

Study start: October 2004;  Expected completion: August 2006

45 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, we 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.

Eligibility

Ages Eligible for Study:  25 Years and above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00133601

Michael Perlis, PhD      585-275-3568    michael_perlis@URMC.rochester.edu
Carla Jungquist      585-475-3379    carla_jungquist@URMC.rochester.edu

New York
      University of Rochester Neurophysiology and Sleep Research Laboratory, Rochester,  New York,  14642,  United States; Recruiting
Carla Jungquist  585-475-3379    Carla_Jungquist@URMC.Rochester.edu 
Michael Perlis, PhD,  Principal Investigator

Study chairs or principal investigators

Michael Perlis, PhD,  Principal Investigator,  University of Rochester   

More Information

Study ID Numbers:  9080; 5R21NR009080-02
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133601
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23


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September 7, 2008



Page Updated: September 6, 2005
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