Brief Pain Exposure Therapy for Fibromyalgia (BPET) Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Physician diagnosis of fibromyalgia (FM) - 2016 American College of Rheumatology (ACR) Criteria for FM: Widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9.

- Able to read, write and speak English.

- Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home.

Exclusion Criteria:

- Indication of a co-occurring (non-fibromyalgia) cause of chronic pain (e.g., inflammatory arthritis, autoimmune disorders, spinal cord injury, cancer) - Currently receiving cognitive-behavioral therapy or other psychological therapies for pain.

- Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.

- Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.

- Pregnant or breastfeeding.

- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06208514
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Michigan
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	John Sturgeon, PhD
Principal Investigator Affiliation	University of Michigan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibromyalgia

Arms & Interventions

Arms

Experimental: Brief pain exposure therapy (BPET)

Interventions

Behavioral: - Brief pain exposure therapy (BPET)

Participants will complete daily logs for 7-days pre-treatment baseline, along with 21 days during the intervention protocol, and 7 for days post-treatment. Brief Pain Exposure Therapy will be given for 3 weeks, 1.5 hours per week, telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, mindfulness meditation, and graded exposure techniques for improving tolerance of painful or feared activities. Participants will also be provided handouts and pre-recorded meditation and imagery scripts that participants can use to facilitate between-session practices. In addition, participants will complete surveys through-out the study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Beth Banner

[email protected]

734-998-5837

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