Chronic Lower Back Pain (CLBP)NCT06771713
Brief Pain Reprocessing Therapy in Veterans
A study testing Brief Pain Reprocessing Therapy (BPRT) in people with Chronic Lower Back Pain (CLBP), run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lower Back Pain (CLBP)
- What is being tested?
- Brief Pain Reprocessing Therapy (BPRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
This study will take place remotely and there will be no on-site visits.
- Conditions
- Chronic Lower Back Pain (CLBP)
- Being tested
- Brief Pain Reprocessing Therapy (BPRT)
- Keywords
- Veterans, Telehealth based intervention, Brief Pain Reprocessing Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Pain Reprocessing Therapy (BPRT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Pain Reprocessing Therapy (BPRT) | Experimental | Participants will have therapy over the internet. Receives: Behavioral: Brief Pain Reprocessing Therapy (BPRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: T6 (Day 60) - T9 (Day 210)
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: T1 (Day1) - T6 (Day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start10 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, John Sturgeon, University of Michigan
- Investigators
- John Sturgeon, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771713
- Sponsor's protocol ID
- HUM00255952
- Other IDs
- GRANT14011002
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Pain Reprocessing Therapy: An Optimized Integrative Exposure Intervention for Veterans With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06771713
- Acronym / sponsor ID
- HUM00255952
- Conditions
- Chronic Lower Back Pain (CLBP)
- Keywords
- Veterans, Telehealth based intervention, Brief Pain Reprocessing Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will take place remotely and there will be no on-site visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Pain Reprocessing Therapy (BPRT) | Experimental | Behavioral: Brief Pain Reprocessing Therapy (BPRT)Participants will have therapy over the internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Brief Pain Reprocessing Therapy (BPRT) |
Primary outcome
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.
3 secondary outcomes
Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK)
Time frame: T1 (Day 1) - T6 (Day 60)
Change from T1 to T6 (Day 60) pain intensity
Time frame: T1 (Day 1) - T6 (Day 60)
Change from T1 to T6 (Day 60) PROMIS Pain Interference
Time frame: T1 (Day1) - T6 (Day 60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sturgeon, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Pain Reprocessing Therapy (BPRT) in people with Chronic Lower Back Pain (CLBP), run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.