Brief Pain Reprocessing Therapy: An Optimized Integrative Exposure Intervention for Veterans With Chronic Low Back Pain
概览
- 阶段
- 不适用
- 干预措施
- Brief Pain Reprocessing Therapy (BPRT)
- 疾病 / 适应症
- Chronic Lower Back Pain (CLBP)
- 发起方
- University of Michigan
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35)
- 状态
- 招募中
- 最后更新
- 23天前
概览
简要总结
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
详细描述
This study will take place remotely and there will be no on-site visits.
研究者
John Sturgeon
Clinical Assistant Professor of Anesthesiology
University of Michigan
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Brief Pain Reprocessing Therapy (BPRT)
Participants will have therapy over the internet.
干预措施: Brief Pain Reprocessing Therapy (BPRT)
结局指标
主要结局
Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK)(T1 (Day 1) - T6 (Day 60))
- Change from T1 to T6 (Day 60) pain intensity(T1 (Day 1) - T6 (Day 60))
- Change from T1 to T6 (Day 60) PROMIS Pain Interference(T1 (Day1) - T6 (Day 60))