Brief Pain Reprocessing Therapy in Veterans

N/AActive Not RecruitingNCT06771713

University of Michigan50 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lower Back Pain (CLBP)

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: Baseline, up to day 35 post treatment

Safety will be assessed by the PROMIS Anxiety scale

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: T1 (Day1) - T6 (Day 60)