Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.
Detailed Description
This mechanistic trial will assess sleep, pain, arousal, and neural imagining outcomes at baseline, post-8 week behavioral treatment (CBT-I or SHE), as well as at 6 and 12 month followups. This information will provide novel information about the neural structures and functional networks associated with chronic pain, and their manipulation through a cognitive behavioral intervention to improve insomnia. Demonstration that a relatively brief intervention can reverse or resolve pain related maladaptive neural plasticity, and improve or resolve clinical pain symptoms would have immediate and far-reaching implications for millions of chronic pain sufferers as well as for the US healthcare system and economy.
Investigators
Christina McCrae
Professor, Psychiatry
University of Missouri-Columbia
Eligibility Criteria
Inclusion Criteria
- •18+ years of age
- •willing to be randomized
- •can read and understand English
- •diagnosed with Fibromyalgia and insomnia
- •no prescript or over the counter pain or sleep medicaments for 1+ month
Exclusion Criteria
- •unable to provide informed consent
- •cognitive impairment
- •sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder
- •bipolar or seizure disorder
- •other major psychopathology (other than depression or anxiety)
- •psychotropic or other medications that alter pain or sleep
- •participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial
- •internal metal objects or electrical devices
- •pregnancy
Outcomes
Primary Outcomes
Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries
Time Frame: baseline to follow-up (approximately 60 weeks)
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 \_\_\_\_\_\_\_\_\_\_\_\_. 1\. very poor 2. poor 3. fair. 4 good 5. Excellent
Change in Insomnia Severity Index (ISI)
Time Frame: baseline to follow-up (approximately 60 weeks)
The Insomnia Severity Index will be administered four times - baseline, post-treatment, and 6 and 12 month follow-up. Analysis will involve examining the trend of change in the ISI.
Change in Perceived Stress Scale
Time Frame: baseline to follow-up (approximately 60 weeks)
measures how much self-reported stress participants experience (from 0-never to 4-very often) across various 10 situations. Higher total scores indicate greater perceived stress.
Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries
Time Frame: baseline to follow-up (approximately 60 weeks)
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.
Change in Thermal Pain Response
Time Frame: baseline to follow-up (approximately 60 weeks)
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.
Change in Peripheral Arousal
Time Frame: baseline to follow-up (approximately 60 weeks)
heart rate variability (as measured by Holter-Monitoring)
Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Time Frame: baseline to follow-up (approximately 60 weeks)
30-item self-report questionnaire designed to identify and assess various sleep/insomnia-related cognitions (e.g., beliefs, attitudes, expectations, appraisals, attributions).
Change in Pain Catastrophizing Scale
Time Frame: baseline to follow-up (approximately 60 weeks)
The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score range from 0-52, with higher scores indicating greater pain catastrophizing.
Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
Time Frame: baseline to follow-up (approximately 60 weeks)
assessment of neural plasticity
Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy
Time Frame: baseline to follow-up (approximately 60 weeks)
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.
Secondary Outcomes
- Polysomnographically assessed sleep onset, wake time after sleep onset, sleep efficiency, number of awakenings, total sleep time, and sleep stage %.(baseline to follow-up (approximately 60 weeks))
- Change in pain severity assessed by the McGill Pain Questionnaire(baseline to follow-up (approximately 60 weeks))
- Change in pain-associated disability assessed by the Pain Disability Questionnaire(baseline to follow-up (approximately 60 weeks))
- Change in Beck Depression Inventory-Second Edition(baseline to follow-up (approximately 60 weeks))
- Saliva Sample(baseline to post-treatment (approximately 12 weeks))
- Change in Pain Anxiety Symptoms Scale(baseline to follow-up (approximately 60 weeks))
- Cognitive Failures Questionnaire(baseline to post-treatment (approximately 12 weeks))
- Cognition - NIH Toolbox(baseline to post-treatment (approximately 12 weeks))
- Global Cognition - Montreal Cognitive Assessment (MoCA)(baseline to post-treatment (approximately 12 weeks))
- Change in State-Trait Anxiety Inventory-Form Y1 (STAI-YI)(baseline to follow-up (approximately 60 weeks))
- Activities of Daily Living (ADL) - Katz ADL Scale(baseline to post-treatment (approximately 12 weeks))
- Biomarkers - Neurodegeneration and Inflammation(baseline to post-treatment (approximately 12 weeks))
- Change in Anxiety and Preoccupation about Sleep Questionnaire(baseline to follow-up (approximately 60 weeks))
- Independent Activities of Daily Living (IADL) - Lawton IADL Scale(baseline to post-treatment (approximately 12 weeks))
- Hair Sample(baseline to post-treatment (approximately 12 weeks))
- Plasma-Based Hormones(baseline to post-treatment (approximately 12 weeks))
- Global Cognition - Mini Mental Status Exam (MMSE)(baseline to follow-up (approximately 60 weeks))