Brief Pain Reprocessing Therapy in Veterans

NCT06771713 | Recruiting

• 2 other identifiers: HUM00255952GRANT14011002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Lower Back Pain (CLBP)

Keywords

Veterans; Telehealth based intervention; Brief Pain Reprocessing Therapy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK)

  T1 (Day 1) - T6 (Day 60)

• Change from T1 to T6 (Day 60) pain intensity

  T1 (Day 1) - T6 (Day 60)

• Change from T1 to T6 (Day 60) PROMIS Pain Interference

  T1 (Day1) - T6 (Day 60)

Study Arms (1)

Brief Pain Reprocessing Therapy (BPRT)

EXPERIMENTAL

Participants will have therapy over the internet.

Behavioral: Brief Pain Reprocessing Therapy (BPRT)

Interventions

Brief Pain Reprocessing Therapy (BPRT) BEHAVIORAL

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.

Brief Pain Reprocessing Therapy (BPRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• John Sturgeon, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Skaikh

CONTACT

734-615-9651; BPRTVeterans@med.umich.edu

Meagan McBride

CONTACT

734-615-9651; BPRTVeterans@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)