AzTrials
AzTrials

Chronic Widespread PainSPIN-CWPNCT02688569

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

A study testing Cognitive Behavioral Therapy for Chronic Widespread Pain in people with Chronic Widespread Pain and Chronic Insomnia, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Widespread Pain, Chronic Insomnia
What is being tested?
Cognitive Behavioral Therapy for Chronic Widespread Pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2016to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Health Psychology, University of Missouri-Columbia

    Columbia, Missouri, 65203

Other trials in United States

About this 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.
Read the detailed description

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.

Being tested
Cognitive Behavioral Therapy for Chronic Widespread Pain
Medical subject headings
Chronic Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for Chronic Widespread PainBehavioural

    Also called CBT-CWP

    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.

Study groups in NCT02688569
Study groupRoleWhat they receive
CBT-CWPExperimentalParticipants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP)
Receives: Behavioral: Cognitive Behavioral Therapy for Chronic Widespread Pain
ControlNo interventionParticipants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

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

  3. 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.

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

  4. 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 ____________.
    11. very poor 2. poor 3. fair. 4 good 5. Excellent

    Measured: 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)

  5. 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.

    Measured: Daily from the start of the study to post-treatment (week1 to week8), two-week daily reports in 3-mo follow up (week21,week22)

  6. 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.

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

Secondary outcomes (14)

  1. Change in heart rate variability

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

  2. Change in Body Mass Index

    Measured: 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

    Measured: 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

    Measured: 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

    Participants will answer these questions:

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

    Measured: 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)

  6. 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.

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

  7. Change in food habits measured by 24-hour dietary recall

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

  8. Change in waist-to-hip ratio

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

  9. Change in blood pressure

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2022
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02688569
Sponsor's protocol ID
2004488HS
Acronym
SPIN-CWP
Status last verified
Mar 2023
First submitted
22 Jan 2016
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 10883557

  • 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.

    PubMed 17974868

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Chronic Widespread Pain in people with Chronic Widespread Pain and Chronic Insomnia, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688569, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in