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Behavioral Intervention
Pain Exposure Therapy for Fibromyalgia (BPET Trial)
N/A
Recruiting
Led By John Sturgeon, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physician diagnosis of fibromyalgia (FM)
Be older than 18 years old
Must not have
Indication of a co-occurring (non-fibromyalgia) cause of chronic pain
Inability to provide informed consent and complete study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 210
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if a short online treatment using Zoom can assist adults with fibromyalgia in learning helpful methods for managing pain, disability, and other associated issues like depression or anxiety.
Who is the study for?
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.
What is being tested?
The study tests Brief Pain Exposure Therapy (BPET), a Zoom-based behavioral treatment designed to teach effective strategies for managing the symptoms of fibromyalgia.
What are the potential side effects?
Since BPET is a type of psychological therapy delivered via Zoom, it does not have physical side effects like medications do. However, discussing painful experiences may cause temporary emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with fibromyalgia by a doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chronic pain not caused by fibromyalgia.
Select...
I am unable to understand or follow the study's procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 210
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 210
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)
Secondary study objectives
Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)
Change in TSK from day 1 (T1) to day 210 (T8)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Brief pain exposure therapy (BPET)Experimental Treatment1 Intervention
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,852 Previous Clinical Trials
6,432,712 Total Patients Enrolled
John Sturgeon, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
300 Total Patients Enrolled
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