Sleep and Pain Interventions in Women With Fibromyalgia
CompletedNot applicableNCT03744156
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia
- Interventions
- Behavioral: Cognitive Behavioral Treatment-Insomnia
- Behavioral: Sleep Hygiene Education
- Sponsor
- University of Missouri-Columbia
- Collaborators
- University of Florida; National Institute of Nursing Research (NINR)
- Start date
- 2019-02-07
- Primary completion
- 2025-05-31
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03744156