- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00127790
Treatment of Insomnia Secondary to Chronic Pain
CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Sleep Research Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Other Names:
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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.
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Other Names:
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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.
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Other Names:
Other Names:
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No Intervention: Wait-List Control (WL)
Waitlist Control condition (WL) with no contact during the intervention period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity
Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
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Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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Pain Severity
Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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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.
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Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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IL-6
Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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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.
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Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Severity
Time Frame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
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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.
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Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wilfred R. Pigeon, Ph.D, University of Rochester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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