Several studies have shown that behavioural therapy for chronic pain can be beneficial for chronic pain and that behavioural therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioural 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.

Official Title

CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes.


  • Insomnia
  • Pain

Study Type


Study Design

Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

  • 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]

Secondary Outcome Measures:

  • Assessments will also be made for mood, quality of life, and personality factors.
    [Time Frame: October 2008]
    [Designated as safety issue: No]

Study Start

June 2005

Eligibility & Criteria

  • Ages Eligible for Study: 35 – 75 years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

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 10:00pm and 8:00am
  • 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

Total Enrolment


Contact Details

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

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