Fibromyalgia study: Cognitive Behavioral Therapy vs Disease Education
Official title Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
ClinicalTrials.gov ID: NCT07023523
What this study is testing
- What it's testing
- This study is testing whether you can use real‑time brain imaging to learn to lower your pain. It also compares two ways to learn these skills: CBT or fibromyalgia education.
- Who it's for
- You may be able to join if you have fibromyalgia and are willing to do MRI scans and weekly therapy sessions.
- What's involved
- You will have two MRI visits where you see your brain activity and try to change it with mental tricks. You will also meet a pain psychologist once a week for eight weeks to learn CBT or education techniques.
- Time commitment
- The study lasts about 10 weeks, with two MRI visits and eight weekly therapy sessions.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Aged 18-65
- Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
- On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
- Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
- Able to provide written consent and fluent in English
You likely can't join if
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
- Pregnant or nursing
- Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
- History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
See the full eligibility criteria
- Aged 18-65
- Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
- On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
- Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
- Able to provide written consent and fluent in English
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
- Pregnant or nursing
- Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
- History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
- Contraindication to MRI (e.g., implanted ferrous metal)
- History of significant head injury (e.g., with substantial loss of consciousness)
- Psychiatric hospitalization in the past 6 months
- Other contraindications to MRI
- Participating in other therapeutic trials
- Active suicidal ideation
- Documented peripheral neuropathy of known cause (e.g diabetic neuropathy, chemotherapy-induced neuropathy, guillain-barre)
- Routine or daily use of narcotics or substances of abuse
- Autoimmune or inflammatory disease (RA, SLE, IBD) that causes pain
- Lower Limb Vascular Surgery or Current Lower Limb Vascular Dysfunction
- Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.