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Treatment of Insomnia Secondary to Chronic Pain
This study is ongoing, but not recruiting participants.
First Received: August 3, 2005   Last Updated: April 14, 2008   History of Changes
Sponsors and Collaborators: University of Rochester
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00127790
  Purpose

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 Intervention
Insomnia
Pain
 Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes

Further study details as provided by University of Rochester:

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 ]

Estimated Enrollment: 44
Study Start Date: June 2005
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain
  1. CBT-I
  2. CBT-P
  3. CBT-P+I
  4. Wait list (control)
2: Experimental Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain
  1. CBT-I
  2. CBT-P
  3. CBT-P+I
  4. Wait list (control)
3: Experimental Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain
  1. CBT-I
  2. CBT-P
  3. CBT-P+I
  4. Wait list (control)
4: No Intervention Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain
  1. CBT-I
  2. CBT-P
  3. CBT-P+I
  4. Wait list (control)

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127790

Locations
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 Institute on Aging (NIA)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Wilfred R. Pigeon, Ph.D University of Rochester
  More Information

Additional Information:
Click here to learn more about our research.  This link exits the ClinicalTrials.gov site
Click here to learn more about our sleep laboratory.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Rochester ( Wilfred R. Pigeon, Ph.D./Primary Investigator )
Study ID Numbers: 160743209, 10274 (IRB#), NS049789-02
Study First Received: August 3, 2005
Last Updated: April 14, 2008
ClinicalTrials.gov Identifier: NCT00127790     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Insomnia
Sleep
Pain
Pain, Chronic
 Behavior Therapy
CBT
CBT-I
cognitive-behavioral

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Neoplasm Metastasis
Dyssomnias
 Sleep Disorders
Pain
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases
 Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 10, 2009



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