Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03744156
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
University of Florida
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Christina McCrae, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE October 9, 2018
First Posted Date  ICMJE November 16, 2018
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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 Peripheral Arousal [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    heart rate variability (as measured by Holter-Monitoring)
  • 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 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.
  • 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.
  • Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    assessment of neural plasticity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03744156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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.
  • Polysomnographically assessed sleep onset, wake time after sleep onset, sleep efficiency, number of awakenings, total sleep time, and sleep stage %. [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    Ambulatory Polysomnography will be conducted four times at baseline, post-treatment, 6-month, and 12 month follow-up. This involves attachment of small electrodes and wires to the head and body.
  • Change in pain severity assessed by the McGill Pain Questionnaire [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    The McGill Pain Questionnaire will be administered four times - baseline, post-treatment, 6 month and 12 month follow-up. Analysis will involve examining the trend of change in the scores in McGill Pain Questionnaire.
  • Change in pain-associated disability assessed by the Pain Disability Questionnaire [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    The Pain Disability Questionnaire will be administered four times - baseline, post-treatment, 6 month follow-up and 12-month follow-up. Analysis will involve examining the trend of change in the scores in Pain Disability Questionnaire.
  • 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 Beck Depression Inventory-Second Edition [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    This 21-item scale measures self-reported depressive symptoms. Total scores range from 0-63, with higher scores indicating greater maladjustment.
  • Change in State-Trait Anxiety Inventory-Form Y1 (STAI-YI) [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    The STAI-Y1 contains 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
  • Change in Pain Anxiety Symptoms Scale [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    A 20 item self-report scale that measures he frequency (0-never, to 5-almost always) of anxiety across situations in which pain is experienced. Total scores range from 0 to 100 with higher scores indicating greater anxiety related to pain.
  • Change in Anxiety and Preoccupation about Sleep Questionnaire [ Time Frame: baseline to follow-up (approximately 60 weeks) ]
    A 10-item scale that asks participants to rate the level of worry and/or anxiety during several situations regarding disturbed sleep. Participant rate the truthfulness of each statement according to their own experience (1-not true to 10-very true). Higher total scores indicate greater anxiety/preoccupation about sleep.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep and Pain Interventions in Women With Fibromyalgia
Official Title  ICMJE Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fibromyalgia
  • Insomnia
  • Chronic Widespread Pain
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Treatment-Insomnia
    8 session Cognitive Behavioral Therapy for Insomnia. Individualized sessions with a therapist.
    Other Name: CBT-I
  • Behavioral: Sleep Hygiene Education
    8 Session Sleep Hygiene Education. Individualized sessions with a therapist.
    Other Name: SHE
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Treatment-Insomnia
    Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.
    Intervention: Behavioral: Cognitive Behavioral Treatment-Insomnia
  • Experimental: Sleep Hygiene Education
    Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.
    Intervention: Behavioral: Sleep Hygiene Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2023
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashley F. Curtis, PhD (573) 884-7487 curtisas@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03744156
Other Study ID Numbers  ICMJE 2011835
1R01NR017168-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christina McCrae, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE
  • University of Florida
  • National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Christina McCrae, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP