Sleep and Pain Interventions in Women With Fibromyalgia

NCT03744156 | Completed DMC

• 2 other identifiers: 20118351R01NR017168-01A1
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Insomnia; Chronic Widespread Pain

Outcome Measures

Primary Outcomes (10)

• 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: 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

  baseline to follow-up (approximately 60 weeks)

• Change in Insomnia Severity Index (ISI)

  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.

  baseline to follow-up (approximately 60 weeks)

• Change in Peripheral Arousal

  heart rate variability (as measured by Holter-Monitoring)

  baseline to follow-up (approximately 60 weeks)

• Change in Perceived Stress Scale

  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.

  baseline to follow-up (approximately 60 weeks)

• Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

  30-item self-report questionnaire designed to identify and assess various sleep/insomnia-related cognitions (e.g., beliefs, attitudes, expectations, appraisals, attributions).

  baseline to follow-up (approximately 60 weeks)

• Change in Pain Catastrophizing Scale

  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.

  baseline to follow-up (approximately 60 weeks)

• 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.

  baseline to follow-up (approximately 60 weeks)

• Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging

  assessment of neural plasticity

  baseline to follow-up (approximately 60 weeks)

• 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.

  baseline to follow-up (approximately 60 weeks)

• 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.

  baseline to follow-up (approximately 60 weeks)

Secondary Outcomes (17)

• 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)

• Change in State-Trait Anxiety Inventory-Form Y1 (STAI-YI)

  baseline to follow-up (approximately 60 weeks)

Study Arms (2)

Cognitive Behavioral Treatment-Insomnia

EXPERIMENTAL

Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.

Behavioral: Cognitive Behavioral Treatment-Insomnia

Sleep Hygiene Education

EXPERIMENTAL

Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.

Behavioral: Sleep Hygiene Education

Interventions

Cognitive Behavioral Treatment-Insomnia BEHAVIORAL

8 session Cognitive Behavioral Therapy for Insomnia. Individualized sessions with a therapist.

Also known as: CBT-I

Cognitive Behavioral Treatment-Insomnia

Sleep Hygiene Education BEHAVIORAL

8 Session Sleep Hygiene Education. Individualized sessions with a therapist.

Also known as: SHE

Sleep Hygiene Education

Eligibility Criteria

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

You may qualify if:

• female
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of Florida: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Missouri- Department of Psychiatry

Columbia, Missouri, 65210, United States

Location

Related Publications (1)

• 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.

  PMID: 32933953 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina McCrae, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: November 16, 2018
• Study Start: February 7, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)