Brief Pain Exposure Therapy for Fibromyalgia (BPET) Study

Fibromyalgia Clinical Trial

— BPET  

Official title:

Brief Pain Exposure Therapy for Fibromyalgia - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208514
• Other study ID #: HUM00238637
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Beth Banner
• Phone: 734-998-5837
• Email: eledward[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Feasibility based on the number of sessions attended	Higher number of sessions attended shows higher level of feasibility.	Day 29
Secondary	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
Secondary	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