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| ID | Type | Description | Link |
|---|---|---|---|
| F32NS049789 | U.S. NIH Grant/Contract | View source | |
| K23NR010408 | U.S. NIH Grant/Contract | View source | |
| R21AG023956; R24AG031089 | Other Identifier | Rochester Center for MindBody Research | |
| R21AG023956 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Insomnia (CBT-I) | Active Comparator | 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. |
|
| CBT for Pain (CBT-P) | Active Comparator | 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. |
|
| CBT for Insomnia & Pain (CBT-I/P) | Experimental | Combined Cognitive-Behavioral Therapy for Insomnia & Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions. |
|
| Wait-List Control (WL) | No Intervention | Waitlist Control condition (WL) with no contact during the intervention period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT for Insomnia (CBT-I) | Behavioral |
|
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfred R. Pigeon, Ph.D | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Sleep Research Laboratory | Rochester | New York | 14642 | United States |
Participants completed intake interview, physical exam, clinical chemistries and toxicology screens; completed daily pain-sleep diaries for two weeks; and then underwent polysomnography. Seven subjects were excluded prior to randomization (4 due to sleep apnea, 1 did not meet pain severity criteria, and 2 subsequently declined to participate).
Men and women aged 35-75 experiencing chronic pain and insomnia were recruited from the community through newspaper advertisements and from local pain clinics via recruitment flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy 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. |
| FG001 | Cognitive-Behavioral Therapy 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. |
| FG002 | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention. |
| FG003 | Wait-List Control (WL) | Waitlist Control condition (WL) with no contact during the intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment |
| |||||||||||||
| Post-Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | completed the intervention and self report instruments | Posted | Mean | Standard Error | units on a scale | Pre to Post Treatment Change (Over an average of approximately 10 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive-Behavioral Therapy 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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The foremost limitation of this pilot study is its small sample size, particularly for a four-arm design. Accordingly, a cautious approach to the interpretation of the findings is warranted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wilfred Pigeon, PhD | Universityy of Rochester | (585) 275-3374 | wilfred_pigeon@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| CBT for Pain (CBT-P) | Behavioral |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Cognitive-Behavioral Therapy 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. |
| BG002 | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention. |
| BG003 | Wait-List Control (WL) | Waitlist Control condition (WL) with no contact during the intervention period. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
| OG002 | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention. |
| OG003 | Wait-List Control (WL) | Waitlist Control condition (WL) with no contact during the intervention period. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | Pre to Post Treatment Change (Over an average of approximately 10 weeks) |
|
|
|
|
| Primary | 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. | Subjects completing blood draws to obtain plasma. One subject in the CBT-I&P condition did not complete blood draws. | Posted | Mean | Standard Error | pg/mL | Pre to Post Treatment Change (Over an average of approximately 10 weeks) |
|
|
|
|
| Secondary | 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. | participants who completed intervention and pre and post treatment assessments | Posted | Mean | Standard Error | units on a scale | Pre to Post Treatment Chnage (Over an average of approximately 10 weeks) |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Cognitive-Behavioral Therapy 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. | 0 | 5 | 0 | 5 |
| EG002 | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention. | 0 | 6 | 0 | 6 |
| EG003 | Wait-List Control (WL) | Waitlist Control condition (WL) with no contact during the intervention period. | 0 | 4 | 0 | 4 |
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| D001523 |
| Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.112 |
| Mean Difference (Final Values) |
| -1.2 |
| No |
| Superiority or Other |
| Two-tailed comparison of pre-post scores | Generalized Estimating Equations | 0.737 | Mean Difference (Final Values) | 1.3 | No | Superiority or Other |
| 0.786 |
| Mean Difference (Final Values) |
| 0.4 |
| No |
| Superiority or Other |
| Two-tailed comparison of pre-post scores. | Generalized Estimating Equations | 0.039 | Mean Difference (Final Values) | 0.0 | No | Superiority or Other |
| 0.187 |
| Mean Difference (Final Values) |
| 7.4 |
| No |
| Superiority or Other |
| Two-tailed comparison of pre-post scores. | Generalized Estimating Equations | 0.015 | Mean Difference (Final Values) | 13.2 | No | Superiority or Other |