Brief Pain Reprocessing Therapy in Veterans

Brief Pain Reprocessing Therapy: An Optimized Integrative Exposure Intervention for Veterans With Chronic Low Back Pain

This research is studying whether a Zoom-based behavioral intervention may have an impact as a treatment for Veterans with Chronic Low Back Pain (CLBP).

The study will examine:

• The acceptability of the Brief Pain Reprocessing Therapy (BPRT) intervention
• The feasibility of the BPRT intervention
• The safety of the BPRT intervention

Study Overview

• Status: Recruiting
• Conditions: Chronic Lower Back Pain (CLBP)
• Intervention / Treatment: Behavioral: Brief Pain Reprocessing Therapy (BPRT)

Detailed Description

This study will take place remotely and there will be no on-site visits.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meagan McBride; Phone Number: 734-615-9651; Email: BPRTVeterans@med.umich.edu
• Study Contact Backup: Name: Sana Skaikh; Phone Number: 734-615-9651; Email: BPRTVeterans@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: John Sturgeon, PhD
      • Contact: Vivian Kurtz; Email: BPRTVeterans@med.umich.edu
      • Contact: Meagan McBride; Email: BPRTVeterans@med.umich.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Low back pain that has lasted greater than 6 months, with pain on at least half of these days
• Must provide verification of being an Armed Service Veteran.
• Able to read, write and speak English
• Internet access and audio-conferencing capability (e.g., Zoom meetings by phone or computer) in the home

Exclusion Criteria:

• Self-reported evidence of a separate medical condition (e.g., rheumatoid arthritis), acute injury in the past 12 months (e.g., self-reported spinal fracture), self-reported loss of bowel or bladder control in the past year (which may indicate presence of cauda equina syndrome), or evidence of presence of a metastasizing cancer requiring treatment
• Pending surgical procedures or interventional therapies (e.g., spinal injections) within the next 12 months
• Confirmed/suspected pregnancy
• Evidence of other conditions that may preclude participants from understanding or being able to participate in study procedure (e.g., schizoaffective disorder, suspected or diagnosed dementia)
• Currently receiving cognitive-behavioral therapy or other psychological therapies for pain
• Open litigation in the past 1 year, as assessed in preliminary study screening.
• 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 Reprocessing Therapy (BPRT); Participants will have therapy over the internet.	Behavioral: Brief Pain Reprocessing Therapy (BPRT); Participants will have three 90-minute behavioral intervention sessions over a 3-week period, completing 35 days of brief daily assessments, and one additional set of questionnaires. Participants will also complete study questionnaires at 1, 2, 3, and 6 months after attending the 3 behavioral intervention sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35)	The TEI-SF is a validated instrument for behavioral interventions. There are 9 questions that participants answer from 1 (strongly disagree) - 5 (strongly agree) with a range of (9-45) with a higher score indicating greater acceptability. Scores at 27 or above will denote moderate acceptability of the intervention.	Approximately day 35 (post treatment)
Feasibility will be accessed by participant adherence	Adherence to the intervention will be determined by at least 80% attendance of intervention sessions, completion of daily assessment, and self-reported adherence to home-base exposure practices, completion of pre/post session and pre/post interventions.	Up to approximately day 35 (post treatment)
Feasibility will be accessed by feedback from the Qualitative Interviews	Qualitative Interviews will occur after conclusion of the intervention period to address areas of improvement in future iterations of the intervention.	Approximately day 35 (post treatment)
Safety will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS 29) pain intensity	There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable).	Baseline, up to day 35 post treatment
Safety will be assessed by the PROMIS Depression scale	Participants will answer 4 questions 1 (never) -5 (always). There is a range of scores from 4-20 with a higher score indicating higher levels of depression.	Baseline, up to day 35 post treatment
Safety will be assessed by the PROMIS Anxiety scale	Participants will answer 4 questions 1 (never) -5 (always). There is a range of scores from 4-20 with a higher score indicating higher levels of anxiety.	Baseline, up to day 35 post treatment
Safety will be assessed by the Patient Global Impression of Change (PGIC)	There is 1 question that participants will select from 1 (very much improved) - 7 (very much worse).	Baseline, up to day 35 post treatment
Safety assessed by the number of Adverse events and Serious adverse events T6 (Day 60) - T9 (Day 210)	Adverse events will be classified as serious or non-serious (per protocol). These will be assessed by items such as death, life-threatening event, hospitalization, emergency room visits, persistent or significant disability/incapacity, suicide plans or attempts.	T6 (Day 60) - T9 (Day 210)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK)	There are 17 questions that participants will select from a score of 1 (strongly disagree) - 4 (strongly agree). A total score is calculated after reversing items 4, 8, 12 and 16. The scores range between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia.	T1 (Day 1) - T6 (Day 60)
Change from T1 to T6 (Day 60) pain intensity	There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable).	T1 (Day 1) - T6 (Day 60)
Change from T1 to T6 (Day 60) PROMIS Pain Interference	Participants will answer 4 questions 1 (not at all) -5 (very much). There is a range of scores from 4-20 with a higher score indicating higher levels of interference.	T1 (Day1) - T6 (Day 60)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: John Sturgeon, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Telehealth based intervention; Brief Pain Reprocessing Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HUM00255952; GRANT14011002 (Other Grant/Funding Number: Department of Defense)

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
• product manufactured in and exported from the U.S.: No