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This randomized controlled clinical trial will examine the effects of Cognitive Behavioral Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia.
Specific Aims:
This randomized controlled clinical trial will examine the effects of CBT in patients with chronic widespread pain and insomnia. Sample will include 20 patients ([18]-65 years) who satisfy criteria for chronic widespread pain and insomnia. Participants will be randomly assigned to CBT or waitlist control. All participants randomized to the cognitive-behavioral interventions will receive 4 treatment sessions (~50 minutes each). Baseline, posttreatment, [& 3-mo.] follow-up assessments will include measures of sleep, pain, thermal pain response, heart rate variability, brain structure and functions, affect, cognitive functioning, cardiovascular health, and substance use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-CWP | Experimental | Participants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP) |
|
| Control | No Intervention | Participants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Chronic Widespread Pain | Behavioral | CBT-CWP in this study involves 4 sessions of one-hour non-drug behavioral intervention. Session 1 involves education about pain and insomnia and the relationship between the two. Participants will also learn sleep hygiene and stimulus control skills. Session 3 involves teaching participants skills to limit non-sleep time in bed and thus increase sleep efficiency. Participants will also learn the relationship between pain and activity. Session 4 involves teaching participants cognitive restructuring and mindfulness skills to manage maladaptive thoughts related to pain and insomnia. Participants will also review the skills they learned and discuss the maintenance of treatment gains. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries | Participants will rate how much pain they experience and how unpleasant the pain is on a scale of 1 to 100 on the daily dairies. Analysis will involve examining the trend of changes in these ratings. | Participants will complete the pain ratings daily for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22) |
| Change in pain severity assessed by the McGill Pain Questionnaire | The McGill Pain Questionnaire will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the scores in McGill Pain Questionnaire. | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in pain-associated disability assessed by the Pain Disability Questionnaire | The Pain Disability Questionnaire will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the scores in Pain Disability Questionnaire. | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries | Participants will answer the following questions on the daily diaries:
1. very poor 2. poor 3. fair. 4 good 5. Excellent |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate variability | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) | |
| Change in Body Mass Index | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
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Inclusion Criteria:
18+ years old
Be willing to be randomly assigned to either the treatment condition or the control condition
Be able to read and understand English
Have Chronic Widespread Pain (CWP) and Insomnia based on the criteria below:
o CWP:
Complaints of pain in upper, lower body, on both sides and the back that lasts for 3+ months.
Not explained by other illnesses except somatic disorders.
o Insomnia:
Insomnia complaints for 6+ months
Occur despite adequate opportunity and circumstances for sleep
Consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep
Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
Baseline diaries indicate >30 minutes of sleep latency or wake after sleep onset combined on 6+ nights.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina S McCrae, Ph.D. | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health Psychology, University of Missouri-Columbia | Columbia | Missouri | 65203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Atkinson, J. H., Ancoli-Israel, S., Slater, M., Garfin, S. R., & Gillin, J. C. (1988). Subjective sleep disturbance in chronic pain. Clinical Journal of Pain, 4, 225-232. | ||
| 10883557 | Background | Currie SR, Wilson KG, Pontefract AJ, deLaplante L. Cognitive-behavioral treatment of insomnia secondary to chronic pain. J Consult Clin Psychol. 2000 Jun;68(3):407-16. doi: 10.1037//0022-006x.68.3.407. | |
| 17974868 |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Participants will complete the sleep questions daily for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22) |
| Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy | Actiwatch-L (ACT-L; Mini Mitter, Inc.) will be used to obtain a behavioral measure of sleep outcome. ACT-L is a wristwatch-like device that provides long-term monitoring of ambient light exposure and gross motor activity in human subjects. The Actiware-Sleep software provides behavioral estimates for several sleep variables: (1) sleep onset latency-interval between bedtime and sleep start; (2) total sleep time-sum of all sleep epochs within the sleep period; (3) sleep efficiency percentage- ratio of total sleep time to total time spent in bed × 100; and (4) total wake time-sum of all wake epochs within the sleep period. | Daily from the start of the study to post-treatment (week1 to week8), two-week daily reports in 3-mo follow up (week21,week22) |
| Change in Insomnia Severity Index | The Insomnia Severity Index will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the Insomnia Severity Index. | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in Cognitive Functioning measured by the NIH toolbox Cognitive Domain | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Day-to-day change in Cognitive Functioning measured by the Cognitive Diary | Participants will complete cognitive diary daily for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22) |
| Change in daily substance use | Participants will answer these questions: Drug Used________________ Prescription Drug? Y/N If yes, used as directed? Y/N Amount taken______________ Time taken________________ | Participants will report daily substance use for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22) |
| Change in Thermal Pain Response | Participants will undergo quantitative sensory testing using a contact thermode applied to the volar surface of the forearm. The protocol that will assess both first pain (primarily A-delta function) and second pain (primarily C-fiber input). All thermal stimuli will be delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-2001, Ramat Yishai, Israel). Visual Analog Scale (VAS) ratings of 4 graded intensities (45, 47, 49, 51° C) of 5 second temperature stimuli will be obtained in the following fashion: Stimulus presentation will be timed such that no site is stimulated with less than a 3-minute interval to avoid sensitization of the site. Participants will rate 8 stimuli (2 at each intensity) using a VAS for pain intensity anchored at the right end by "the most intense pain imaginable." A second random sequence of 8 stimuli (2 at each intensity) will be rated by VAS for pain unpleasantness. | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in food habits measured by 24-hour dietary recall | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in waist-to-hip ratio | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in blood pressure | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in alcohol use frequency as measured by the Alcohol Use Questionnaire | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in alcohol problems as measured by the Alcohol Use Disorders Identification Test | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in grey matter volume as measured by Structural MRI | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in cortical thickness as measured by Structural MRI | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Change in functional connectivity in response to thermal pain stimuli as measured by Functional MRI | Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22) |
| Background |
| McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6. |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |