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FibromyalgiaSPIN-IINCT03744156

Sleep and Pain Interventions in Women With Fibromyalgia

A study testing Cognitive Behavioral Treatment-Insomnia and Sleep Hygiene Education in people with Fibromyalgia and Insomnia, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fibromyalgia, Insomnia, Chronic Widespread Pain
What is being tested?
Cognitive Behavioral Treatment-Insomnia and Sleep Hygiene Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteUnited States
Study dates
7 Feb 2019to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial
  • internal metal objects or electrical devices
  • pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Missouri- Department of Psychiatry

    Columbia, Missouri, 65210

Other trials in United States

About this study

Official title: Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia

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.

Read the 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.

Being tested
Cognitive Behavioral Treatment-Insomnia, Sleep Hygiene Education
Medical subject headings
Fibromyalgia, Sleep Initiation and Maintenance Disorders, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Treatment-InsomniaBehavioural

    Also called CBT-I

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

  • Sleep Hygiene EducationBehavioural

    Also called SHE

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

Study groups in NCT03744156
Study groupRoleWhat they receive
Cognitive Behavioral Treatment-InsomniaExperimentalCognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.
Receives: Behavioral: Cognitive Behavioral Treatment-Insomnia
Sleep Hygiene EducationExperimentalSleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.
Receives: Behavioral: Sleep Hygiene Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline to follow-up (approximately 60 weeks)

  2. 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.

    Measured: baseline to follow-up (approximately 60 weeks)

  3. Change in Peripheral Arousal

    heart rate variability (as measured by Holter-Monitoring)

    Measured: baseline to follow-up (approximately 60 weeks)

  4. 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.

    Measured: baseline to follow-up (approximately 60 weeks)

  5. 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).

    Measured: baseline to follow-up (approximately 60 weeks)

  6. 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.

    Measured: baseline to follow-up (approximately 60 weeks)

  7. 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.

    Measured: baseline to follow-up (approximately 60 weeks)

  8. Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging

    assessment of neural plasticity

    Measured: baseline to follow-up (approximately 60 weeks)

  9. 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.

    Measured: baseline to follow-up (approximately 60 weeks)

  10. 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.

    Measured: baseline to follow-up (approximately 60 weeks)

Secondary outcomes (17)

  1. Polysomnographically assessed sleep onset, wake time after sleep onset, sleep efficiency, number of awakenings, total sleep time, and sleep stage %.

    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.

    Measured: baseline to follow-up (approximately 60 weeks)

  2. Change in pain severity assessed by the McGill Pain Questionnaire

    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.

    Measured: baseline to follow-up (approximately 60 weeks)

  3. Change in pain-associated disability assessed by the Pain Disability Questionnaire

    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.

    Measured: baseline to follow-up (approximately 60 weeks)

  4. Change in Beck Depression Inventory-Second Edition

    This 21-item scale measures self-reported depressive symptoms. Total scores range from 0-63, with higher scores indicating greater maladjustment.

    Measured: baseline to follow-up (approximately 60 weeks)

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

    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.

    Measured: baseline to follow-up (approximately 60 weeks)

  6. Change in Pain Anxiety Symptoms Scale

    A 20 item self-report scale that measures the 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.

    Measured: baseline to follow-up (approximately 60 weeks)

  7. Change in Anxiety and Preoccupation about Sleep Questionnaire

    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.

    Measured: baseline to follow-up (approximately 60 weeks)

  8. Activities of Daily Living (ADL) - Katz ADL Scale

    A 6-item scale that measures the degree of independence on activities of daily living (1-independent; 0-dependent; activities include bathing, dressing, toileting, transferring, continence and feeding). Higher total scores indicate greater degree of independence on ADLs

    Measured: baseline to post-treatment (approximately 12 weeks)

  9. Independent Activities of Daily Living (IADL) - Lawton IADL Scale

    A 8-item scale that measures the degree of independence in performing instrumental activities of daily living (1-independent; 0-dependent; instrumental daily activities include ability to use telephone, shopping, food preparation, housekeeping, laundry, transportation, responsibility for own medications, and finances). Higher total scores indicate greater degree of independence on IADLs

    Measured: baseline to post-treatment (approximately 12 weeks)

  10. Cognitive Failures Questionnaire

    A 25-item scale measuring subjective cognition; caregivers rate on a scale of 0 (never) to 4 (very often) how often they experience cognitive mistakes and errors in daily tasks

    Measured: baseline to post-treatment (approximately 12 weeks)

  11. Cognition - NIH Toolbox

    A 20-minute computerized battery completed in a single setting on iPad (20 in. screen); domains tested include processing speed and attention, visuospatial ability and memory, verbal learning and memory, and executive functioning and working memory

    Measured: baseline to post-treatment (approximately 12 weeks)

  12. Hair Sample

    A sample of hair (cut, not extracted/no hair bulb) will be analyzed for the inflammatory and stress hormone cortisol

    Measured: baseline to post-treatment (approximately 12 weeks)

  13. Saliva Sample

    A sample of saliva will be analyzed to determine if the APOE-4 genetic marker is present.

    Measured: baseline to post-treatment (approximately 12 weeks)

  14. Biomarkers - Neurodegeneration and Inflammation

    Blood based biomarkers and hormones will be examined at each assessment period; biomarkers include CRP \& IL-6, AβB42, AβB40 \& total tau and phosphorylated-Tau at threonine181 \& threonine217

    Measured: baseline to post-treatment (approximately 12 weeks)

  15. Plasma-Based Hormones

    Blood plasma analysis of three hormones including estradiol, testosterone, and cortisol

    Measured: baseline to post-treatment (approximately 12 weeks)

  16. Global Cognition - Mini Mental Status Exam (MMSE)

    An 11-item questionnaire that provides a measure of global cognition. Participants are asked questions related to orientation to time/place, memory immediate/ delayed recall, attention and calculation, naming, repetition, comprehension, reading, writing, and drawing. Participants are scored 0-incorrect or 1- correct on each item. Total score is computed (out of 30), with higher total scores indicating better global cognitive function.

    Measured: baseline to follow-up (approximately 60 weeks)

  17. Global Cognition - Montreal Cognitive Assessment (MoCA)

    A 30-item questionnaire that provides a measure of global cognition. Participants are asked questions related to visuospatial/executive functioning, naming, memory immediate/delayed recall, attention, language, abstraction, and orientation to time/place. Participants are scored 0-incorrect or 1-correct on each item. Total score is computed (out of 30), with higher total scores indicating better global cognitive function.

    Measured: baseline to post-treatment (approximately 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2018
  2. Study start7 Feb 2019
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03744156
Sponsor's protocol ID
2011835
Other IDs
1R01NR017168-01A1
Acronym
SPIN-II
Status last verified
Sep 2025
First submitted
9 Oct 2018
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32933953

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Treatment-Insomnia and Sleep Hygiene Education in people with Fibromyalgia and Insomnia, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03744156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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