NCT03744156 · COMPLETED
Sleep and Pain Interventions in Women With Fibromyalgia
This trial is testing whether Cognitive Behavioral Therapy for Insomnia works better than basic sleep hygiene education for women who have both fibromyalgia and insomnia. Researchers are also studying how sleep and brain function relate to chronic pain. This is a Phase NA randomized controlled trial, meaning it is a direct head-to-head comparison study rather than a traditional drug-development phase.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-10-01