RECRUITING

Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

Conditions

Fibromyalgia Lupus Erythematosus, Systemic Chronic Pelvic Pain Chronic Low Back Pain (CLBP)Pain exposure therapy Telehealth-based behavioral intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

Quick Facts

Study Start:2024-03-04

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06208514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * Physician diagnosis of fibromyalgia * OR: meet 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 * OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician. * Physician diagnosis of systemic lupus erythematosus * AND: Have pain self-reported in 4 out of 7 body regions in the GSS-brief body map * AND: No change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease). * Low Back Pain for at least half the days over the past 6 months * Over the past 7 days, an average pain intensity of at least 4 out of 10	* Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other 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. * Lupus group only: taking \>10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications) * Chronic Pelvic Pain group only: surgery for any chronic pelvic pain related condition in the past 6 months * Chronic low back pain only: scheduled back surgery; leg pain that is greater than your back pain

Inclusion Criteria

Exclusion Criteria

* 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
* Physician diagnosis of fibromyalgia
* OR: meet 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
* OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician.
* Physician diagnosis of systemic lupus erythematosus
* AND: Have pain self-reported in 4 out of 7 body regions in the GSS-brief body map
* AND: No change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease).
* Low Back Pain for at least half the days over the past 6 months
* Over the past 7 days, an average pain intensity of at least 4 out of 10

* Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other 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.
* Lupus group only: taking \>10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications)
* Chronic Pelvic Pain group only: surgery for any chronic pelvic pain related condition in the past 6 months
* Chronic low back pain only: scheduled back surgery; leg pain that is greater than your back pain

Contacts and Locations

Study Contact

Beth Banner

CONTACT

734-998-5837

eledward@med.umich.edu

Principal Investigator

John Sturgeon, PhD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

John Sturgeon, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-04

Study Completion Date2026-07

Study Record Updates

Study Start Date2024-03-04

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Pain exposure therapy
Telehealth-based behavioral intervention

Additional Relevant MeSH Terms

Fibromyalgia
Lupus Erythematosus, Systemic
Chronic Pelvic Pain
Chronic Low Back Pain (CLBP)