Recruiting NCT06771713
Brief Pain Reprocessing Therapy in Veterans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief Pain Reprocessing Therapy (BPRT).
- Who it may be relevant to
- Registry conditions: Chronic Lower Back Pain (CLBP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brief Pain Reprocessing Therapy: An Optimized Integrative Exposure Intervention for Veterans With Chronic Low Back Pain
Overview
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.
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)]
- Feasibility will be accessed by participant adherence [Time frame: Up to approximately day 35 (post treatment)]
- Feasibility will be accessed by feedback from the Qualitative Interviews [Time frame: Approximately day 35 (post treatment)]
- 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]
- Safety will be assessed by the PROMIS Depression scale [Time frame: Baseline, up to day 35 post treatment]
- Safety will be assessed by the PROMIS Anxiety scale [Time frame: Baseline, up to day 35 post treatment]
- Safety will be assessed by the Patient Global Impression of Change (PGIC) [Time frame: 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) [Time frame: T6 (Day 60) - T9 (Day 210)]
Secondary outcome measures (3)
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06771713 · HUM00255952 · GRANT14011002