Pain Exposure Therapy for Fibromyalgia
(BPET Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Inflammatory arthritis, Autoimmune disorders, Cancer, others
No Placebo Group
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.
12345Is 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.
13678How 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.
12349Eligibility 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.
Able to read, write and speak English
+1 more
Exclusion Criteria
Pregnant or breastfeeding
I have chronic pain not caused by fibromyalgia.
I am currently undergoing therapy for pain management.
+3 more
Trial 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
Participant Groups
The study tests Brief Pain Exposure Therapy (BPET), a Zoom-based behavioral treatment designed to teach effective strategies for managing the symptoms of fibromyalgia.
1Treatment groups
Experimental Treatment
Group I: Brief pain exposure therapy (BPET)Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
References
[Imagined exposure as treatment of catastrophizing in fibromyalgia: a pilot study]. [2018]We want to assess the effectiveness of a new approach (imagined exposure) for the Cognitive Behavioural Treatment (CBT) in fibromyalgia.
Efficacy, acceptability and safety of Internet-delivered psychological therapies for fibromyalgia syndrome: A systematic review and meta-analysis of randomized controlled trials. [2019]This systematic review aimed at evaluating the efficacy, acceptability and safety of Internet-based psychological therapies (IPTs) in fibromyalgia syndrome (FMS). Clinicaltrials.gov, Cochrane Library, MEDLINE, PsycINFO and SCOPUS were searched from inception to January 2018. Randomized controlled trials (RCTs) comparing IPTs with controls were analysed. Primary outcomes were ≥50% pain relief, disability, negative mood, acceptability and safety at end of therapy and at 6-month follow up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI). Six RCTs using different types of Internet-based cognitive-behavioural therapies [ICBTs] (acceptance-based; exposure-based; traditional) with 493 patients were included. At the end of treatment, ICBTs were superior to controls (waiting list, attention control, treatment as usual) in reducing negative mood (SMD -0.51 [95% CI -0.87 to -0.15]) (moderate quality evidence) and disability (SMD -0.56 [95% CI -1.00 to -0.13]) (moderate quality evidence). There were no statistically significant differences between ICBTs and controls in pain relief of 50% or greater (RD 0.09 [95% CI -0.02 to 0.20] (moderate quality evidence) and acceptability (moderate quality evidence). No data on safety and any outcomes at long-term follow-up compared to controls were found. The data available did not allow statistical comparisons between unguided and guided ICBTs and of ICBTs versus traditional face-to-face therapies. ICBTs provided a clinically relevant benefit over control interventions in reducing negative mood and disability at the end of treatment. SIGNIFICANCE: Internet-delivered cognitive behavioural therapies provided a clinically relevant benefit in reducing negative mood and disability in patients with FMS at the end of treatment if compared to waiting list, treatment as usual and attention controls.
Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial. [2019]Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM.
Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments. [2022]The present study focused on the evaluation of the effects of operant behavioural (OBT) and cognitive behavioural (CBT) treatments for fibromyalgia syndrome (FMS). One hundred and twenty-five patients who fulfilled the American College of Rheumatology criteria for FMS were randomly assigned to OBT (n = 43), CBT (n = 42), or an attention-placebo (AP) treatment (n = 40) that consisted of discussions of FMS-related problems. Assessments of physical functioning, pain, affective distress, and cognitive and behavioural variables were performed pre-treatment and post-treatment as well as 6 and 12 months post-treatment. Patients receiving the OBT or CBT reported a significant reduction in pain intensity post-treatment (all Fs > 3.89, all Ps 7.95, all P 2.99, all Ps 5.99, all Ps
Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention. [2018]Sustained improvement in physical functional status was the primary goal of a brief, 6 session cognitive behavioral therapy (CBT) protocol for fibromyalgia (FM).
Exposure and CBT for chronic back pain: An RCT on differential efficacy and optimal length of treatment. [2022]Our aim was to establish whether Exposure, a specialized tailored treatment for chronic low back pain, has any advantages over cognitive-behavioral therapy (CBT) among individuals with high fear-avoidance levels. Second, we planned to compare short and long versions of Exposure. Third, we aimed to investigate whether Exposure can be delivered in an outpatient psychological setting.
[Exposure therapy for chronic back pain]. [2021]Exposure therapy is an economical and promising psychological method for the treatment of chronic back pain, although little research has been done and its evidence needs further clarification. Exposure therapy has so far been little used in practice, which is partly due to the few published studies on this topic and partly to the uncertainty of the practitioners as to whether exposure therapy can be carried out without risk. Exposure therapy can be classified as a "tailored treatment" approach, in which patients with certain profiles (here: increased fear of movement) receive specific treatments. In this review article, the theoretical principles of exposure therapy are presented. Subsequently, possibilities for the identification of those patients suitable for exposure treatment are explained. The practical procedure is presented using a case study. The four randomized controlled trials available to date are described in detail and discussed.
Bridging the gap: Utilizing insights from exposure therapy in the innovation of chronic musculoskeletal pain treatment. [2023]For some time, the gold standard treatment for anxiety disorders has been exposure therapy, defined as the repeated approach of anxiety-inducing situations, memories, or physiological sensations. Existing treatments to target fear and avoidance of pain can be augmented by innovations from exposure research in the anxiety disorders, including greater emphasis on safety learning, the utilization of imaginal exposure to catastrophic fears, and exposure to contrasting emotions. Given that treatments to target core, maintaining mechanisms of anxiety, including imaginal exposures, can be administered as self-directed treatments without therapist involvement, they represent important avenues for ensuring the millions of people with chronic musculosketal pain can gain access to psychosocial treatment and reduce the interference of pain in their lives. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Cost-Effectiveness and Cost-Utility of Internet-Delivered Exposure Therapy for Fibromyalgia: Results From a Randomized, Controlled Trial. [2020]Fibromyalgia (FM) is a prevalent and debilitating chronic pain disorder associated with a substantial economic burden. Although there are several studies investigating the effectiveness of psychological treatments such as cognitive-behavioral therapy for FM, studies on cost-effectiveness are scarce. The aim of the present study was to investigate the cost-effectiveness of Internet-delivered exposure therapy (iExp) for FM. We used health economic data from a recently conducted randomized, controlled trial, where 140 participants were randomized to either iExp or a waitlist control (WLC) condition. Economic data were collected at pre-treatment, post-treatment, and at the 1-year follow-up. Treatment effectiveness in relation to costs were analyzed using both a societal perspective (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between iExp and WLC, within different willingness-to-pay scenarios. Results showed that the incremental cost-effectiveness ratio was -$15,295, indicating that iExp was highly cost-effective as each successfully treated case (treatment responder) was associated with a substantial net reduction in costs. The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0. We conclude that iExp is a cost-effective treatment that generates large societal cost savings. PERSPECTIVE: Health-economic evaluations of psychological interventions for FM are scarce. This study is a cost-effectiveness analysis of Internet-delivered exposure therapy for patients with FM. Results showed that iExp was highly cost-effective compared with no treatment, where each successfully treated case generated a substantial societal cost saving.