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NCT Number: NCT00127790

Treatment of Insomnia Secondary to Chronic Pain

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.

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Key information

Conditions

Insomnia Chronic Pain Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Sleep Research Laboratory

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT for Insomnia (CBT-I)

Behavioral

Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I)

CBT for Pain (CBT-P)

Behavioral

Other names: Cognitive-Behavioral Therapy for Pain (CBT-P)

Primary outcomes

  1. Insomnia Severity

    Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)

    Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.

  2. Pain Severity

    Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)

    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.

  3. IL-6

    Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)

    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.

Secondary outcomes

  1. Depression Severity

    Time frame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 8, 2005
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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