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Treatment of Insomnia Secondary to Chronic Pain
This study is ongoing, but not recruiting participants.
Study NCT00127790   Information provided by University of Rochester
First Received: August 3, 2005   Last Updated: April 14, 2008   History of Changes

August 3, 2005
April 14, 2008
June 2005
October 2008   (final data collection date for primary outcome measure)
  • 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 (T1-T4) under evaluation [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00127790 on ClinicalTrials.gov Archive Site
Assessments will also be made for mood, quality of life, and personality factors. [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
Assessments will also be made for mood, quality of life, and personality factors.
 
Treatment of Insomnia Secondary to Chronic Pain
CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes

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 for 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.

The investigators' 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.

The investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function.

The investigators' 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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Insomnia
  • Pain
Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
44
November 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 35-75
  • Chronic non-malignant painful condition of the spine of > 6 months duration
  • Insomnia (> 30 minutes sleep latency and/or wake after sleep onset time for > 3 days/week 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 hypnotic medications

Exclusion Criteria:

  • Unstable medical or psychiatric illness
  • History of seizures
  • Evidence of active illicit substance use or fitting criteria for ethanol (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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127790
Wilfred R. Pigeon, Ph.D./Primary Investigator, University of Rochester
160743209, 10274 (IRB#), NS049789-02
University of Rochester
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
Principal Investigator: Wilfred R. Pigeon, Ph.D University of Rochester
University of Rochester
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP