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Treatment of Insomnia Secondary to Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00127790
Recruitment Status : Completed
First Posted : August 8, 2005
Results First Posted : October 17, 2012
Last Update Posted : October 17, 2012
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Wilfred Pigeon, University of Rochester

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Pain Behavioral: CBT for Insomnia (CBT-I) Behavioral: CBT for Pain (CBT-P) Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
Study Start Date : June 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: CBT for Insomnia (CBT-I)
Other Name: Cognitive-Behavioral Therapy 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.
 Behavioral: CBT for Pain (CBT-P)
Other Name: Cognitive-Behavioral Therapy 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.
 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)
No Intervention: Wait-List Control (WL)
Waitlist Control condition (WL) with no contact during the intervention period.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127790


Locations
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United States, New York
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Wilfred R. Pigeon, Ph.D University of Rochester
More Information
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Responsible Party: Wilfred Pigeon, Asst Prof, University of Rochester
ClinicalTrials.gov Identifier: NCT00127790    
Other Study ID Numbers: 160743209
F32NS049789 ( U.S. NIH Grant/Contract )
K23NR010408 ( U.S. NIH Grant/Contract )
R21AG023956; R24AG031089 ( Other Identifier: Rochester Center for MindBody Research )
R21AG023956 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2005    Key Record Dates
Results First Posted: October 17, 2012
Last Update Posted: October 17, 2012
Last Verified: September 2012
Keywords provided by Wilfred Pigeon, University of Rochester:
Insomnia
Sleep
Pain
Pain, Chronic
 Behavior Therapy
CBT
CBT-I
cognitive-behavioral
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Chronic Pain
Pain
Neurologic Manifestations
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders