An interventional study of Cognitive Behavioral Therapy for Chronic Widespread Pain in Chronic Widespread Pain and Chronic Insomnia, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 20 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Have Chronic Widespread Pain (CWP) and Insomnia based on the criteria below:
o CWP:
Not explained by other illnesses except somatic disorders.
o Insomnia:
Exclusion Criteria:
Participants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP)
Behavioral: Cognitive Behavioral Therapy for Chronic Widespread Pain
Participants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments.
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.
Also known as: CBT-CWP
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.
Time frame: 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.
Time frame: 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.
Time frame: 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. I napped for ____________ minutes yesterday. 2. I napped ______ times yesterday. 3. I napped in the ___morning ___afternoon ____evening (check all that apply) 4. I went to bed last night at ____________ AM/PM. 5. It took me ____________ minutes to fall asleep. 6. I woke up ____________ times last night. 7. I was awake for ____________ minutes in the middle of the night. 8. My final wake up time was ____________ AM/PM. 9. I got out of bed at ____________ AM/PM. 10. I would rate my quality of sleep last night as ____________. 1. very poor 2. poor 3. fair. 4 good 5. Excellent
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Change in heart rate variability
Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Change in Body Mass Index
Time frame: 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
Time frame: 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
Time frame: 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________________
Time frame: 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.
Time frame: 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
Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Change in waist-to-hip ratio
Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Change in blood pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
University of Missouri-Columbia