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Treatment of Insomnia Secondary to Chronic Pain

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Wilfred Pigeon, University of Rochester
ClinicalTrials.gov Identifier:
NCT00127790
First received: August 3, 2005
Last updated: September 14, 2012
Last verified: September 2012

August 3, 2005
September 14, 2012
June 2005
October 2008   (final data collection date for primary outcome measure)
  • Insomnia Severity [ Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks) ] [ Designated as safety issue: No ]
    Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
  • Pain Severity [ Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks) ] [ Designated as safety issue: No ]
    Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.
  • IL-6 [ Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks) ] [ Designated as safety issue: No ]
    Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.
  • 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
Depression Severity [ Time Frame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks) ] [ Designated as safety issue: No ]
Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.
Assessments will also be made for mood, quality of life, and personality factors.
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Insomnia
  • Pain
  • Behavioral: CBT for Insomnia (CBT-I)
    Other Name: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
  • Behavioral: CBT for Pain (CBT-P)
    Other Name: Cognitive-Behavioral Therapy for Pain (CBT-P)
  • Active Comparator: CBT for Insomnia (CBT-I)
    Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
    Intervention: Behavioral: CBT for Insomnia (CBT-I)
  • Active Comparator: CBT for Pain (CBT-P)
    Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
    Intervention: Behavioral: CBT for Pain (CBT-P)
  • Experimental: CBT for Insomnia & Pain (CBT-I/P)
    Combined Cognitive-Behavioral Therapy for Insomnia & Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions.
    Interventions:
    • Behavioral: CBT for Insomnia (CBT-I)
    • Behavioral: CBT for Pain (CBT-P)
  • No Intervention: Wait-List Control (WL)
    Waitlist Control condition (WL) with no contact during the intervention period.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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
160743209, F32NS049789, K23NR010408, R21AG023956; R24AG031089
No
Wilfred Pigeon, University of Rochester
University of Rochester
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)
  • National Institute of Nursing Research (NINR)
Principal Investigator: Wilfred R. Pigeon, Ph.D University of Rochester
University of Rochester
September 2012

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