Treatment of Insomnia Secondary to Chronic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insomnia, Pain

Intervention / Treatment
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* Behavioral: CBT for Insomnia (CBT-I)
* Behavioral: CBT for Pain (CBT-P)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT for Insomnia (CBT-I)<br>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)<br> <br> * Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I);|
| Active Comparator: CBT for Pain (CBT-P)<br>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)<br> <br> * Other names: Cognitive-Behavioral Therapy for Pain (CBT-P);|
| Experimental: CBT for Insomnia & Pain (CBT-I/P)<br>Combined Cognitive-Behavioral Therapy for Insomnia & Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions. | Behavioral: CBT for Insomnia (CBT-I)<br> <br> * Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I);Behavioral: CBT for Pain (CBT-P)<br> <br> * Other names: Cognitive-Behavioral Therapy for Pain (CBT-P);|
| No Intervention: Wait-List Control (WL)<br>Waitlist Control condition (WL) with no contact during the intervention period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity | Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia. | Pre to Post Treatment Change (Over an average of approximately 10 weeks) | 
| Pain Severity | 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. | Pre to Post Treatment Change (Over an average of approximately 10 weeks) | 
| IL-6 | 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. | Pre to Post Treatment Change (Over an average of approximately 10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Severity | 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. | Pre to Post Treatment Chnage (Over an average of approximately 10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Insomnia, Sleep, Pain, Pain, Chronic, Behavior Therapy, CBT-I, cognitive-behavioral