Insomnia, Pain
Conditions
Keywords
Insomnia, Sleep, Pain, Pain, Chronic, Behavior Therapy, CBT, CBT-I, cognitive-behavioral
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.
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.
Interventions
BEHAVIORALCBT for Insomnia (CBT-I)
BEHAVIORALCBT for Pain (CBT-P)
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity | 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. |
| Pain Severity | 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. |
| IL-6 | 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
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 5 |
| 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. | 6 |
| Wait-List Control (WL) Waitlist Control condition (WL) with no contact during the intervention period. | 4 |
| Total | 21 |
Baseline characteristics
| Characteristic | Cognitive-Behavioral Therapy for Pain (CBT-P) | Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Wait-List Control (WL) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 20 Participants |
| Age Continuous | 55.8 years STANDARD_DEVIATION 9.8 | 50.5 years STANDARD_DEVIATION 8.5 | 45.7 years STANDARD_DEVIATION 8.2 | 52.3 years STANDARD_DEVIATION 1 | 50.7 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment United States | 5 participants | 6 participants | 6 participants | 4 participants | 21 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants | 2 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 4 |
Outcome results
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.
Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Population: Subjects completing blood draws to obtain plasma. One subject in the CBT-I\&P condition did not complete blood draws.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | IL-6 | 0.7 pg/mL | Standard Error 0.2 |
| Cognitive-Behavioral Therapy for Pain (CBT-P) | IL-6 | 1.6 pg/mL | Standard Error 1 |
| Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | IL-6 | 1.2 pg/mL | Standard Error 0.2 |
| Wait-List Control (WL) | IL-6 | 1.2 pg/mL | Standard Error 0.3 |
Comparison: Two-tailed comparison of pre-post scoresp-value: 0.063Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scoresp-value: 0.786Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.039Generalized Estimating Equations
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.
Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Population: completed the intervention and self report instruments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Insomnia Severity | 6.0 units on a scale | Standard Error 1.9 |
| Cognitive-Behavioral Therapy for Pain (CBT-P) | Insomnia Severity | 12.8 units on a scale | Standard Error 1.1 |
| Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Insomnia Severity | 4.4 units on a scale | Standard Error 1 |
| Wait-List Control (WL) | Insomnia Severity | 13.0 units on a scale | Standard Error 1.7 |
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.01Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.581Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scoresp-value: 0.011Generalized Estimating Equations
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.
Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Pain Severity | 11.0 units on a scale | Standard Error 2.3 |
| Cognitive-Behavioral Therapy for Pain (CBT-P) | Pain Severity | 6.2 units on a scale | Standard Error 1.7 |
| Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Pain Severity | 8.8 units on a scale | Standard Error 1.9 |
| Wait-List Control (WL) | Pain Severity | 7.5 units on a scale | Standard Error 1 |
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.33Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.112Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scoresp-value: 0.737Generalized Estimating Equations
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.
Time frame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
Population: participants who completed intervention and pre and post treatment assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Depression Severity | 2.3 units on a scale | Standard Error 1.9 |
| Cognitive-Behavioral Therapy for Pain (CBT-P) | Depression Severity | 10.2 units on a scale | Standard Error 2.9 |
| Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) | Depression Severity | 4.4 units on a scale | Standard Error 1.8 |
| Wait-List Control (WL) | Depression Severity | 17.6 units on a scale | Standard Error 1.2 |
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.016Generlaized Estimating Equations
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.187Generalized Estimating Equations
Comparison: Two-tailed comparison of pre-post scores.p-value: 0.015Generalized Estimating Equations