Brief Pain Reprocessing Therapy in Veterans
ConditionChronic Lower Back Pain (CLBP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Brief Pain Reprocessing Therapy (BPRT)
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Brief Pain Reprocessing Therapy (BPRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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 treatmentSecondary outcomes
1
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)2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov