Brief Pain Exposure Therapy for Fibromyalgia (BPET) Study (BPET)

Brief Pain Exposure Therapy for Fibromyalgia - A Pilot Study

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).

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Brief pain exposure therapy (BPET)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Banner; Phone Number: 734-998-5837; Email: eledward@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: John Sturgeon, PhD
      • Contact: Beth Banner; Phone Number: 734-998-5837; Email: eledward@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Brief pain exposure therapy (BPET)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)	This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).	Day 1, Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)	This is a 17-item survey that participants answer strongly disagree (1) to strongly agree (4). Total scores are between 17-68 with a higher value indicating higher kinesiophobia.	Day 1, Day 60
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)	Four questions are included in the PROMIS for pain interference. Participants will answer from not at all (1) to very much (5). Scores range from 4-20 with a higher score indicating more interference.	Day 1, Day 60
Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)	This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).	Day 1, Day 210
Change in TSK from day 1 (T1) to day 210 (T8)	This is a 17-item survey that participants answer strongly disagree (1) to strongly agree (4). Total scores are between 17-68 with a higher value indicating higher kinesiophobia.	Day 1, Day 210
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)	Four questions are included in the PROMIS for pain interference. Participants will answer from not at all (1) to very much (5). Scores range from 4-20 with a higher score indicating more interference.	Day 1, Day 210
Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)	This is a 10-item survey that participant will complete after final intervention. Questions are answered from strongly disagree (1), neither agree or disagree (4), to agree (7). Scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention).	Day 29
Feasibility based on the number of sessions attended	Higher number of sessions attended shows higher level of feasibility.	Day 29
Feasibility based on the number of in-session and between-session practices completed	Higher number of sessions and between-sessions completed shows higher level of feasibility.	Day 29
Feasibility based on open-ended feedback at the completion of the intervention	Participants will complete the open-ended feedback form that has 4 questions regarding the intervention and will be summarized.	Day 29

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: John Sturgeon, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pain exposure therapy; Telehealth-based behavioral intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: HUM00238637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No