NCT06771713 · University of Michigan
Brief Pain Reprocessing Therapy in Veterans
What this study is about
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).
View original scientific description
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).
Interventions
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.
Primary outcome measures
Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35)
Time frame: Approximately day 35 (post treatment)
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.
Feasibility will be accessed by participant adherence
Time frame: Up to approximately day 35 (post treatment)
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.
Feasibility will be accessed by feedback from the Qualitative Interviews
Time frame: Approximately day 35 (post treatment)
Qualitative Interviews will occur after conclusion of the intervention period to address areas of improvement in future iterations of the intervention.
Safety will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS 29) pain intensity
Time frame: Baseline, up to day 35 post treatment
There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable).
Safety will be assessed by the PROMIS Depression scale
Time frame: Baseline, up to day 35 post treatment
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.
Safety will be assessed by the PROMIS Anxiety scale
Time frame: Baseline, up to day 35 post treatment
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.
Safety will be assessed by the Patient Global Impression of Change (PGIC)
Time frame: Baseline, up to day 35 post treatment
There is 1 question that participants will select from 1 (very much improved) - 7 (very much worse).
Safety assessed by the number of Adverse events and Serious adverse events T6 (Day 60) - T9 (Day 210)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Ann Arbor, Michigan
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations