Clinical trial NCT02688569: Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
Official title: Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Widespread Pain
Chronic Insomnia
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries
timeFrame: 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)
measure: Change in pain severity assessed by the McGill Pain Questionnaire
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in pain-associated disability assessed by the Pain Disability Questionnaire
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries
timeFrame: 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)
measure: Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy
timeFrame: Daily from the start of the study to post-treatment (week1 to week8), two-week daily reports in 3-mo follow up (week21,week22)
measure: Change in Insomnia Severity Index
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Secondary outcomes:
measure: Change in heart rate variability
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in Body Mass Index
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in Cognitive Functioning measured by the NIH toolbox Cognitive Domain
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Day-to-day change in Cognitive Functioning measured by the Cognitive Diary
timeFrame: 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)
measure: Change in daily substance use
timeFrame: 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)
measure: Change in Thermal Pain Response
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in food habits measured by 24-hour dietary recall
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in waist-to-hip ratio
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in blood pressure
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in alcohol use frequency as measured by the Alcohol Use Questionnaire
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in alcohol problems as measured by the Alcohol Use Disorders Identification Test
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in grey matter volume as measured by Structural MRI
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in cortical thickness as measured by Structural MRI
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
measure: Change in functional connectivity in response to thermal pain stimuli as measured by Functional MRI
timeFrame: Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Department of Health Psychology, University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Christina S McCrae, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.