Pain Exposure Therapy for Fibromyalgia

(BPET Trial)

Overseen By Beth Banner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Inflammatory arthritis, Autoimmune disorders, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brief Zoom-based behavioral treatment to help individuals with fibromyalgia and lupus manage pain and reduce related issues like depression or anxiety. The treatment, called Brief Pain Exposure Therapy, is a type of exposure-based cognitive behavioral therapy designed to teach effective pain management strategies. Suitable candidates include those with a doctor's diagnosis of fibromyalgia or lupus, who experience pain in multiple body areas, and have stable medication routines. Participants need internet access and the ability to use Zoom. As an unphased trial, this study provides a unique opportunity to access innovative pain management strategies that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this behavioral treatment is safe for fibromyalgia and Lupus patients?

Research has shown that therapies like Brief Pain Exposure Therapy (BPET) are generally safe for people with fibromyalgia. Studies comparing exposure-based cognitive behavior therapy (Exp-CBT) with traditional cognitive behavior therapy (T-CBT) found both treatments well-tolerated, with no major safety differences. These therapies often help manage pain and improve quality of life.

While specific safety data for BPET might not be available, similar therapies in past research have usually been safe. Prospective participants should discuss any concerns with their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Pain Exposure Therapy (BPET) for fibromyalgia because it takes a unique approach to managing pain. Unlike typical treatments that often involve medications like antidepressants and pain relievers, BPET focuses on gradually exposing patients to pain in a controlled setting to help them reduce their pain sensitivity over time. This method aims to retrain the brain's response to pain, potentially offering relief without the side effects associated with many current medications. This innovative approach could provide a new avenue for those who haven't found success with traditional treatments.

What evidence suggests that this trial's treatment could be effective for fibromyalgia and lupus?

Research has shown that online cognitive behavioral therapies (CBTs) can improve mood and reduce disability in people with fibromyalgia. This trial will focus on Brief Pain Exposure Therapy (BPET), which teaches pain management techniques. While BPET remains under study, similar therapies have benefited fibromyalgia patients. One study found that both exposure-based CBT and traditional CBT effectively manage fibromyalgia symptoms. These treatments can also enhance overall mood and reduce anxiety or depression. ^{1 2 5 6 7}

Who Is on the Research Team?

John Sturgeon, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with fibromyalgia, a condition causing widespread pain and tenderness. Participants should be comfortable using Zoom for therapy sessions aimed at reducing pain and related issues like disability, depression, or anxiety.

Inclusion Criteria

Internet access and audio-visual conferencing capability in the home

I have been diagnosed with fibromyalgia by a doctor.

Meeting 2016 American College of Rheumatology (ACR) Criteria for FM

Exclusion Criteria

Pregnant or breastfeeding

I have chronic pain not caused by fibromyalgia.

I am currently undergoing therapy for pain management.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Brief Pain Exposure Therapy (BPET) via Zoom to learn strategies for reducing pain and disability

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in pain intensity and other outcomes

30 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Pain Exposure Therapy (BPET)

Trial Overview The study tests Brief Pain Exposure Therapy (BPET), a Zoom-based behavioral treatment designed to teach effective strategies for managing the symptoms of fibromyalgia.

How Is the Trial Designed?

Group I: Brief pain exposure therapy (BPET) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study involving 8 fibromyalgia patients, Cognitive Behavioral Treatment (CBT) showed improvements in pain catastrophizing, particularly with the imagined exposure technique, although no significant changes were observed in pain intensity or overall fibromyalgia impact.

The results indicate that while CBT can help reduce negative thought patterns related to pain, further research with larger groups is necessary to validate these findings and explore the effectiveness of imagined exposure in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imagined exposure as treatment of catastrophizing in fibromyalgia: a pilot study]. Rodero, B., García, J., Casanueva, B., et al.[2018]

Internet-delivered exposure therapy (iExp) for fibromyalgia (FM) was found to be highly cost-effective, with an incremental cost-effectiveness ratio of -$15,295, indicating significant cost savings for each successfully treated case.

The study involved 140 participants and demonstrated that iExp not only effectively treated FM but also generated substantial societal cost savings, making it a valuable option for managing this chronic pain disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Cost-Utility of Internet-Delivered Exposure Therapy for Fibromyalgia: Results From a Randomized, Controlled Trial. Hedman-Lagerlöf, M., Hedman-Lagerlöf, E., Ljótsson, B., et al.[2020]

Exposure therapy remains the gold standard for treating anxiety disorders, focusing on repeated engagement with anxiety-inducing situations to promote safety learning and reduce fear.

Innovative approaches, such as self-directed imaginal exposure to fears and contrasting emotions, can help individuals with chronic musculoskeletal pain access effective psychosocial treatments without needing a therapist, potentially improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap: Utilizing insights from exposure therapy in the innovation of chronic musculoskeletal pain treatment. McDermott, K., Keefe, F., Vranceanu, AM.[2023]

In a study of 145 fibromyalgia patients, those who received 6 sessions of cognitive behavioral therapy (CBT) alongside standard medical care showed a higher rate of clinically meaningful long-term improvement in physical functioning (25%) compared to those receiving only standard care (12%).

While CBT improved physical functioning, it did not lead to significant differences in pain ratings between the two groups, indicating that CBT may be more effective for enhancing physical capabilities rather than directly reducing pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention. Williams, DA., Cary, MA., Groner, KH., et al.[2018]

Exposure therapy was found to be more effective than cognitive-behavioral therapy (CBT) in reducing movement-related disability in individuals with chronic low back pain and high fear-avoidance levels, as measured by the QBPDS questionnaire.

The short version of Exposure therapy led to faster improvements compared to the long version, indicating that fewer sessions may be more beneficial for patients, although more participants dropped out of the Exposure treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure and CBT for chronic back pain: An RCT on differential efficacy and optimal length of treatment. Glombiewski, JA., Holzapfel, S., Riecke, J., et al.[2022]

Exposure therapy is a promising and cost-effective psychological treatment for chronic back pain, particularly for patients with a heightened fear of movement, but more research is needed to establish its efficacy and safety.

Currently, there are only four randomized controlled trials on exposure therapy for back pain, which limits its practical application and raises concerns among practitioners about its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exposure therapy for chronic back pain]. Glombiewski, JA.[2021]

Internet-based cognitive-behavioral therapies (ICBTs) significantly reduced negative mood and disability in fibromyalgia syndrome patients compared to control groups, based on a systematic review of 6 randomized controlled trials involving 493 patients.

However, ICBTs did not show a significant difference in achieving 50% pain relief compared to controls, indicating that while they are effective for mood and disability, their impact on pain relief may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, acceptability and safety of Internet-delivered psychological therapies for fibromyalgia syndrome: A systematic review and meta-analysis of randomized controlled trials. Bernardy, K., Klose, P., Welsch, P., et al.[2019]

In a study of 125 fibromyalgia patients, both operant behavioral therapy (OBT) and cognitive behavioral therapy (CBT) significantly reduced pain intensity post-treatment, with effects lasting up to 12 months.

CBT led to notable improvements in cognitive and affective distress, while OBT showed significant enhancements in physical functioning, highlighting the distinct benefits of each therapy compared to an attention-placebo group, which experienced no improvement and even deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments. Thieme, K., Flor, H., Turk, DC.[2022]

A randomized controlled trial with 140 participants showed that a 10-week Internet-delivered exposure therapy significantly improved fibromyalgia symptoms and overall impact compared to a waitlist control, with a large effect size (Cohen d=0.90).

The treatment also led to substantial improvements in secondary outcomes such as fatigue, disability, and quality of life, with effects sustained at 6 and 12 months, indicating that Internet-based therapy can enhance accessibility for patients with fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial. Hedman-Lagerlöf, M., Hedman-Lagerlöf, E., Axelsson, E., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06208514

Brief Pain Exposure Therapy (BPET) For Nociplastic Pain This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM) and Lupus learn effective strategies ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090030/

Effect of exposure-based vs traditional cognitive behavior ... Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both ...

3. withpower.com withpower.com/trial/phase-fibromyalgia-2024-183f1?condition=fibromyalgia&overallStatus=Recruiting&hasNoPlacebo=false

Pain Exposure Therapy for Fibromyalgia (BPET Trial) Research shows that Internet-delivered cognitive behavioral therapies (CBTs) can help reduce negative mood and disability in fibromyalgia patients. Additionally ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05058911

Exposure-based Cognitive Behavior Therapy vs Traditional ... The most extensively evaluated treatment for FM is traditional cognitive behavior therapy (T-CBT) which typically appears to have small to moderate effects when ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590025006029

Cost-effectiveness and cost-utility of exposure-based vs. ... This article presents a cost-effectiveness evaluation of online exposure therapy compared to online traditional CBT for fibromyalgia.

6. 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 ...

7. jpain.org jpain.org/article/S1526-5900(25)00602-9/pdf

Results from This study aimed to evaluate the cost-effectiveness of online exposure therapy (EXP-CBT) versus online traditional CBT (T-. CBT) for FM. We ...