Clinical trial NCT06771713: Brief Pain Reprocessing Therapy in Veterans
Official title: Brief Pain Reprocessing Therapy: An Optimized Integrative Exposure Intervention for Veterans With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Lower Back Pain (CLBP)
Keywords: Veterans
Telehealth based intervention
Brief Pain Reprocessing Therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2025-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: Approximately day 35 (post treatment)
measure: Feasibility will be accessed by participant adherence
timeFrame: Up to approximately day 35 (post treatment)
measure: Feasibility will be accessed by feedback from the Qualitative Interviews
timeFrame: Approximately day 35 (post treatment)
measure: Safety will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS 29) pain intensity
timeFrame: Baseline, up to day 35 post treatment
measure: Safety will be assessed by the PROMIS Depression scale
timeFrame: Baseline, up to day 35 post treatment
measure: Safety will be assessed by the PROMIS Anxiety scale
timeFrame: Baseline, up to day 35 post treatment
measure: Safety will be assessed by the Patient Global Impression of Change (PGIC)
timeFrame: Baseline, up to day 35 post treatment
measure: Safety assessed by the number of Adverse events and Serious adverse events T6 (Day 60) - T9 (Day 210)
timeFrame: T6 (Day 60) - T9 (Day 210)
Secondary outcomes:
measure: Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK)
timeFrame: T1 (Day 1) - T6 (Day 60)
measure: Change from T1 to T6 (Day 60) pain intensity
timeFrame: T1 (Day 1) - T6 (Day 60)
measure: Change from T1 to T6 (Day 60) PROMIS Pain Interference
timeFrame: T1 (Day1) - T6 (Day 60)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John Sturgeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: