Skip to main content
OpenTrials
Completed

NCT Number: NCT02688569

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

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:

1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with comorbid CWP and insomnia. 2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue compared to the waitlist control (WLC). 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health compared WLC. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV), CS (thermal response) and neural plasticity (brain function and structure) - compared to WLC.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Widespread Pain Chronic Insomnia Chronic Pain Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Psychology, University of Missouri-Columbia

Columbia, Missouri, 65203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Be unable to provide informed consent
  • Be unwilling to undergo randomization
  • Be unable to complete forms and implement treatment due to cognitive impairment (Mini Mental State Examination <26)
  • Sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15]; Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour >15])
  • bipolar or seizure disorder
  • other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
  • severe untreated psychiatric comorbidity that renders randomization unethical,
  • psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep
  • participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue, or mood outside the current study,
  • internal metal objects or electrical devices
  • pregnancy

Treatment and study plan

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.

Other names: CBT-CWP

Primary outcomes

  1. Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries

    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)

    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.

  2. Change in pain severity assessed by the McGill Pain Questionnaire

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

    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.

  3. Change in pain-associated disability assessed by the Pain Disability Questionnaire

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

    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.

  4. Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries

    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)

    Participants will answer the following questions on the daily diaries:

    • I napped for ____________ minutes yesterday.
    • I napped ______ times yesterday.
    • I napped in the ___morning ___afternoon ____evening (check all that apply)
    • I went to bed last night at ____________ AM/PM.
    • It took me ____________ minutes to fall asleep.
    • I woke up ____________ times last night.
    • I was awake for ____________ minutes in the middle of the night.
    • My final wake up time was ____________ AM/PM.
    • I got out of bed at ____________ AM/PM.
    • I would rate my quality of sleep last night as ____________.
    • very poor 2. poor 3. fair. 4 good 5. Excellent

  5. Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy

    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)

    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.

  6. Change in Insomnia Severity Index

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

    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.

Secondary outcomes

  1. Change in heart rate variability

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

  2. Change in Body Mass Index

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

  3. 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)

  4. 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)

  5. Change in daily substance use

    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)

    Participants will answer these questions:

    Drug Used________________ Prescription Drug? Y/N If yes, used as directed? Y/N Amount taken______________ Time taken________________

  6. Change in Thermal Pain Response

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

    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.

  7. 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)

  8. Change in waist-to-hip ratio

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

  9. Change in blood pressure

    Time frame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Acronym: SPIN-CWP

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2016
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.