Brief Pain Reprocessing Therapy in Veterans

Официальное название

Brief Pain Reprocessing Therapy: An Optimized Integrative Exposure Intervention for Veterans With Chronic Low Back Pain

Обзор

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

Подробное описание

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

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35) [Срок оценки: Approximately day 35 (post treatment)]
• Feasibility will be accessed by participant adherence [Срок оценки: Up to approximately day 35 (post treatment)]
• Feasibility will be accessed by feedback from the Qualitative Interviews [Срок оценки: Approximately day 35 (post treatment)]
• Safety will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS 29) pain intensity [Срок оценки: Baseline, up to day 35 post treatment]
• Safety will be assessed by the PROMIS Depression scale [Срок оценки: Baseline, up to day 35 post treatment]
• Safety will be assessed by the PROMIS Anxiety scale [Срок оценки: Baseline, up to day 35 post treatment]
• Safety will be assessed by the Patient Global Impression of Change (PGIC) [Срок оценки: 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) [Срок оценки: T6 (Day 60) - T9 (Day 210)]

Вторичные конечные точки (3)

• Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK) [Срок оценки: T1 (Day 1) - T6 (Day 60)]
• Change from T1 to T6 (Day 60) pain intensity [Срок оценки: T1 (Day 1) - T6 (Day 60)]
• Change from T1 to T6 (Day 60) PROMIS Pain Interference [Срок оценки: T1 (Day1) - T6 (Day 60)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06771713 · HUM00255952 · GRANT14011002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗