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NCT03744156: SPIN-II

Sleep and Pain Interventions in Women With Fibromyalgia

Completed NA Last updated 1 October 2025
What this trial tests

NA trial testing Cognitive Behavioral Treatment-Insomnia in Fibromyalgia in 131 participants. Completed in 31 May 2025.

Timeline
7 February 2019
Primary endpoint
31 May 2025
31 May 2025

Quick facts

Lead sponsorUniversity of Missouri-Columbia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment131
Start date7 February 2019
Primary completion31 May 2025
Estimated completion31 May 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Missouri-Columbia

Who can join

18 and older, female only, with Fibromyalgia or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study.
    McCrae CS, Craggs JG, Curtis AF, Nair N, et al · · 2022 · cited 10× · PMID 34310276 · DOI 10.5664/jcsm.9540
  2. Protocol for the impact of CBT for insomnia on pain symptoms and central sensitisation in fibromyalgia: a randomised controlled trial.
    McCrae CS, Curtis AF, Craggs J, Deroche C, et al · · 2020 · cited 6× · PMID 32933953 · DOI 10.1136/bmjopen-2019-033760
  3. Preliminary investigation of the interactive role of physiological arousal and insomnia complaints in gray matter volume alterations in chronic widespread pain.
    Curtis AF, Nair N, Hayse B, McGovney K, et al · · 2024 · cited 2× · PMID 37823586 · DOI 10.5664/jcsm.10860

Verify or expand the search:

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

Other University of Missouri-Columbia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03744156.

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