Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment of insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.

Condition	Intervention
Insomnia Pain, Chronic	Behavior: Cognitive-Behavioral Treatment for Insomnia and/or Pain

Further Study Details: 

Primary Outcomes: Sleep Continuity: Two primary measures: Sleep latency and wake-after-sleep-onset time. Each measure will be culled from the daily diaries and averaged to represent weekly means for the 4 time points under evaluation.; Pain Measures will incorporate pain severity, tolerability and function. Pain measures will also be culled from the daily diaries and averaged to represent weekly means.; Immune Measures: Immune measures will consist of three proinflammatory cytokines, IL-1β IL-6 and TNF-α, which will be obtained by drawing plasma samples at T1-T4.
Secondary Outcomes: Assessments will also be made for mood, quality of life, and personality factors.
Expected Total Enrollment:  44

Our primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and Combined insomnia & pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving CBT. This will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity.

Our secondary goal is to assess whether treatment response to any of the interventions are associated with alterations in immune function.

Our tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.

Ages Eligible for Study:  40 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 40-65
• Chronic non-malignant painful condition of the spine of >6 months duration
• Insomnia (> 30 min. sleep latency and/or wake after sleep onset time for > 3 days/wk for > 6 months)
• Insomnia developed after the onset of the painful condition
• Preferred sleep phase between 10:00 p.m. and 8:00 am
• On stable medical regimen for medical and pain conditions (no surgery planned)
• Willingness to discontinue of hypnotic medications

Exclusion Criteria:

• unstable medical or psychiatric illness
• history of seizures
• evidence of active illicit substance use or fitting criteria for ETOH abuse or dependence
• symptoms suggestive of sleep disorders other than insomnia
• polysomnographic data indicating sleep disorders other than insomnia
• inadequate language comprehension
• Fibromyalgia
• Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00127790

Jeffrey Swan, M.A.      585-273-2571    Jeffrey_Swan@urmc.rochester.edu
Heather Kennedy, B.A.      585-4Sleepy    Heather_Kennedy@urmc.rochester.edu

New York
      University of Rochester Sleep Research Laboratory, Rochester,  New York,  14642,  United States; Recruiting

Study chairs or principal investigators

Wilfred R. Pigeon, Ph.D,  Principal Investigator,  University of Rochester   

Study ID Numbers:  160743209; 10274 (IRB#); NS049789-02
Last Updated:  August 5, 2005
Record first received:  August 3, 2005
ClinicalTrials.gov Identifier:  NCT00127790
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23