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

Trial Summary

What is the purpose of this trial?

This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM) and Lupus learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia and Lupus (such as depression or anxiety).

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 data supports the effectiveness of the treatment Pain Exposure Therapy for Fibromyalgia?

Research shows that Internet-delivered cognitive behavioral therapies (CBTs) can help reduce negative mood and disability in fibromyalgia patients. Additionally, exposure therapy has been found to be potentially effective for chronic pain, suggesting it may benefit fibromyalgia patients as well. ^{1 2 3 4 5}

Is Pain Exposure Therapy safe for humans?

Exposure therapy, including its variations like Internet-Delivered Exposure Therapy, has been used safely in treating chronic pain conditions such as back pain and fibromyalgia. While more research is needed, existing studies suggest it can be administered without significant risk. ^{1 3 6 7 8}

How is Pain Exposure Therapy for Fibromyalgia different from other treatments?

Pain Exposure Therapy for Fibromyalgia is unique because it uses exposure-based cognitive behavioral therapy delivered over the internet, which focuses on gradually facing pain-related fears to reduce their impact. This approach is novel compared to traditional treatments, as it is cost-effective and can be accessed remotely, making it more convenient for patients. ^{1 2 3 4 9}

Research Team

John Sturgeon, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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-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]

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]

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]

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]

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Imagined exposure as treatment of catastrophizing in fibromyalgia: a pilot study]. [2018]

2. England 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Exposure and CBT for chronic back pain: An RCT on differential efficacy and optimal length of treatment. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Exposure therapy for chronic back pain]. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Bridging the gap: Utilizing insights from exposure therapy in the innovation of chronic musculoskeletal pain treatment. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Cost-Utility of Internet-Delivered Exposure Therapy for Fibromyalgia: Results From a Randomized, Controlled Trial. [2020]