Cognitive Behavioral Therapy for Fibromyalgia

Overseen By Soobin Choi, [e-mail]

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Stimulants, Narcotics

Disqualifiers: Acute pain, Chronic pain, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with fibromyalgia can use brain activity feedback to better manage their pain. Participants will utilize real-time brain scans to learn and apply mental strategies for pain reduction, supported by weekly sessions with a psychologist. The study divides participants into two groups: one receiving Cognitive Behavioral Therapy (CBT) and the other receiving education about fibromyalgia. This trial suits those who have experienced fibromyalgia pain for at least a year, feel pain on most days, and are willing to maintain stable medication doses during the study. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications, but you must be on stable doses before starting the study and agree not to change them during the trial.

What prior data suggests that self-regulation of real-time fMRI brain activity is safe for fibromyalgia patients?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for treating fibromyalgia. Studies have found that most patients tolerate CBT well, with few reports of negative side effects. It ranks among the top recommended treatments for fibromyalgia due to its safety and effectiveness.

Participants in CBT trials have reported positive outcomes, such as improved sleep and reduced fibromyalgia symptoms, without major negative effects. This suggests that CBT could be a safe option for managing fibromyalgia pain through mental strategies and self-control techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for fibromyalgia because it offers a psychological approach to managing pain, unlike traditional options like medications or physical therapy. This treatment involves self-regulation of real-time fMRI brain activity, which is a new way to potentially influence how the brain processes pain signals. By teaching patients to control their brain activity, this method could help reduce pain perception, offering a novel and non-invasive complement to existing treatments. Additionally, this approach empowers patients with tools to manage their symptoms more independently.

What evidence suggests that self-regulation of real-time fMRI brain activity is effective for fibromyalgia?

Research has shown that Cognitive Behavioral Therapy (CBT), which participants in this trial may receive, effectively manages fibromyalgia. Studies have found that CBT helps people handle pain better, feel less depressed, and reduces the need for doctor visits. One study found that people who did CBT experienced significantly less pain affecting their daily lives. Another study showed that 60% of participants felt a meaningful improvement, with benefits lasting up to a year after treatment. CBT is considered a top treatment for fibromyalgia because of its proven benefits. ^{4 5 6 7 8}

Who Is on the Research Team?

Jeungchan Lee, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with fibromyalgia who are interested in learning how to manage their pain using their brain activity. Participants will need to attend MRI sessions and weekly meetings with a pain psychologist.

Inclusion Criteria

I am between 18 and 65 years old.

My average pain level is at least 4 out of 10 and I experience pain most days.

Able to provide written consent and fluent in English

Exclusion Criteria

Pregnant or nursing

I take stimulant meds for sleep apnea or shift work fatigue.

History of significant head injury (e.g., with substantial loss of consciousness)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI Visit

Participants complete a fMRI neurofeedback session and questionnaires, and undergo experimental pain stimulation

1 day

1 visit (in-person)

Intervention

Participants attend 8 weekly sessions with a pain psychologist for either Cognitive Behavioral Therapy or Fibromyalgia Education

8 weeks

8 visits (in-person)

Post-intervention MRI Visit

Participants repeat the baseline tasks to assess changes in neural mechanisms and pain experience

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and self-regulation performance

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Self-regulation of Real-time fMRI Brain Activity

Trial Overview The study tests if patients can use real-time fMRI feedback to control brain activity and reduce pain, comparing Cognitive Behavioral Therapy (CBT) against Fibromyalgia Education over several weeks.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

8 individual weekly visits with a psychologist for pain-related CBT.

Group II: Disease Education Active Control 1 Intervention

8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Spaulding Rehabilitation Hospital

Collaborator

Trials

143

Recruited

11,200+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK79722/

Efficacy of cognitive-behavioral therapies in fibromyalgia ... The review found that cognitive behavioural therapy (CBT) appeared to improve coping with pain and reduced depressed mood and healthcare-seeking behaviour ...

2. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/cognitive-behavioral-therapy-eases-fibromyalgia-pain-experienced-by-brain

Cognitive Behavioral Therapy Eases How Fibromyalgia ... Results demonstrated that those who underwent CBT experienced significantly greater reductions in pain interference. CBT participants also ...

3. journals.lww.com journals.lww.com/pain/fulltext/2024/06000/effect_of_exposure_based_vs_traditional_cognitive.10.aspx

Effect of exposure-based vs traditional cognitive behavior... Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1877886015000567

Cognitive behaviour therapy in women with fibromyalgia Cognitive behaviour therapy improved the life control in a female population with FMS. Coping behaviour in response to chronic pain was improved at the same ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/features/cbt-and-mbis-for-fibromyalgia/

CBT and Mindfulness-Based Therapies for Fibromyalgia Cognitive behavioral therapy is a first-line treatment for fibromyalgia, based on data demonstrating its efficacy and tolerability among this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7501455/

Combined cognitive-behavioral therapy for fibromyalgia Results: Participants who received CBT-P showed increases in time in bed and total sleep time and decreases in light sleep, but there was no ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0005796724000731

Shared and distinct effect mediators in exposure-based ... In a recent randomized controlled trial (N = 274), we found that Exp-CBT was not superior to T-CBT (d = −0.10) in reducing overall fibromyalgia severity. This ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1108641

Cognitive Behavior Therapy, Exercise, or Both for Treating ... Results The percentages reporting a positive outcome at 6 and 9 months, respectively, were TAU group, 8% and 8%; TCBT group, 30% and 33%; ...