Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

NCT02688569 | Completed DMC

• 1 other identifier: 2004488HS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health compared WLC.
4. 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.

Conditions

Chronic Widespread Pain; Chronic Insomnia

Outcome Measures

Primary Outcomes (6)

• 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. 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

  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)

Secondary Outcomes (14)

• 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)

• 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 report daily substance use for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22)

Study Arms (2)

CBT-CWP

EXPERIMENTAL

Participants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP)

Behavioral: Cognitive Behavioral Therapy for Chronic Widespread Pain

Control

NO INTERVENTION

Participants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments.

Interventions

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.

Also known as: CBT-CWP

CBT-CWP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Department of Health Psychology, University of Missouri-Columbia

Columbia, Missouri, 65203, United States

Location

Related Publications (3)

• 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.

  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.

  PMID: 10883557 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.

  PMID: 17974868 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christina S McCrae, Ph.D.

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 23, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)