Last reviewed · How we verify
NCT03744156: SPIN-II
Sleep and Pain Interventions in Women With Fibromyalgia
NA trial testing Cognitive Behavioral Treatment-Insomnia in Fibromyalgia in 131 participants. Completed in 31 May 2025.
31 May 2025
Quick facts
| Lead sponsor | University of Missouri-Columbia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 131 |
| Start date | 7 February 2019 |
| Primary completion | 31 May 2025 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cognitive Behavioral Treatment-Insomnia
- Sleep Hygiene Education
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
- Insomnia — all drugs for Insomnia →
- Chronic Widespread Pain — all drugs for Chronic Widespread Pain →
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):
-
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 -
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 -
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:
- PubMed search for NCT03744156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fibromyalgia
Currently open trials in the same condition.
- NCT02285868 — ATI Evidence-based Guide Investigating Clinical Services · active not recruiting
- NCT07245303 — Neural Mechanisms of Light Driven Analgesia · NA · recruiting
- NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
- NCT07358754 — The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor · recruiting
- NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia · NA · recruiting
Other University of Missouri-Columbia trials
Trials by the same sponsor.
- NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
- NCT07385105 — Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI) · NA · not yet recruiting
- NCT07067502 — Impact of Biphasic Cuirass Ventilation Compared to Non Invasive Ventilation in High Risk Extubations · NA · not yet recruiting
- NCT07424079 — Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy · NA · not yet recruiting
- NCT07216196 — The Feasibility of a Remote Problem-Solving Intervention for Autistic Adolescents or Young Adults and a Caregiver · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03744156 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Missouri-Columbia
- Last refreshed: 1 October 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing