Clinical trial NCT03744156: Sleep and Pain Interventions in Women With Fibromyalgia
Official title: Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Insomnia
Chronic Widespread Pain
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Florida
name: National Institute of Nursing Research (NINR)
First posted: 2018-11-16
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* female
* 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

Primary outcomes:
measure: Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Insomnia Severity Index (ISI)
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Peripheral Arousal
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Perceived Stress Scale
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Pain Catastrophizing Scale
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Thermal Pain Response
timeFrame: baseline to follow-up (approximately 60 weeks)
Secondary outcomes:
measure: Polysomnographically assessed sleep onset, wake time after sleep onset, sleep efficiency, number of awakenings, total sleep time, and sleep stage %.
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in pain severity assessed by the McGill Pain Questionnaire
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in pain-associated disability assessed by the Pain Disability Questionnaire
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Beck Depression Inventory-Second Edition
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in State-Trait Anxiety Inventory-Form Y1 (STAI-YI)
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Pain Anxiety Symptoms Scale
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Change in Anxiety and Preoccupation about Sleep Questionnaire
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Activities of Daily Living (ADL) - Katz ADL Scale
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Independent Activities of Daily Living (IADL) - Lawton IADL Scale
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Cognitive Failures Questionnaire
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Cognition - NIH Toolbox
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Hair Sample
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Saliva Sample
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Biomarkers - Neurodegeneration and Inflammation
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Plasma-Based Hormones
timeFrame: baseline to post-treatment (approximately 12 weeks)
measure: Global Cognition - Mini Mental Status Exam (MMSE)
timeFrame: baseline to follow-up (approximately 60 weeks)
measure: Global Cognition - Montreal Cognitive Assessment (MoCA)
timeFrame: baseline to post-treatment (approximately 12 weeks)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri- Department of Psychiatry
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Christina McCrae, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCrae CS, Curtis AF, Craggs J, Deroche C, Sahota P, Siva C, Staud R, Robinson M. Protocol for the impact of CBT for insomnia on pain symptoms and central sensitisation in fibromyalgia: a randomised controlled trial. BMJ Open. 2020 Sep 15;10(9):e033760. doi: 10.1136/bmjopen-2019-033760.