Cognitive behavioral treatments for insomnia in women with fibromyalgia
Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia
This study is testing two different sleep treatments to see if they can help women with fibromyalgia and insomnia sleep better and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT03744156 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two cognitive behavioral sleep treatments in women diagnosed with fibromyalgia and insomnia. It aims to assess the impact of these interventions on sleep, pain, arousal, and brain function over an 8-week treatment period, with follow-ups at 6 and 12 months. By examining neural imaging outcomes, the study seeks to uncover the relationship between sleep disturbances and chronic pain, potentially leading to significant improvements in patient care for fibromyalgia sufferers.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have been diagnosed with fibromyalgia and insomnia.
Not a fit: Patients with cognitive impairments, other sleep disorders, or those currently on medications affecting pain or sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological treatments to alleviate chronic pain and insomnia in women with fibromyalgia.
How similar studies have performed: Previous studies have shown promise in using cognitive behavioral interventions for insomnia, suggesting potential success for this approach in fibromyalgia patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbia, Missouri
- University of Missouri- Department of Psychiatry — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Christina McCrae, PhD — University of Missouri-Columbia
- Study coordinator: Austin D Ohley, BS
- Email: ajobzr@health.missouri.edu
- Phone: (573) 882-5113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.