Mindfulness Therapy for Chronic Pain After Intimate Partner Violence (MBCT-TIP)
A Primary Care-Based Adaptation of MBCT for Chronic Pain After Intimate Partner Violence (MBCT-TIP): A Development and Feasibility Study
The goal of this clinical trial is to develop and test a new program called MBCT-TIP for adults with chronic pain and a history of intimate partner violence (IPV). MBCT-TIP combines mindfulness-based cognitive therapy with a trauma-informed approach to pain.
The main question this study aims to answer is:
Will MBCT-TIP be feasible and acceptable for adults with chronic pain and IPV histories?
Researchers will compare MBCT-TIP to a control - Health Enhancement Program (HEP). Comparing the two will help researchers see whether MBCT-TIP is feasible and acceptable for people with chronic pain and a history of IPV.
Participants will:
Attend 8 weekly group sessions, held in person, lasting about 1 hour each. Complete study assessments before starting the program, after finishing the program, and 3 months later
研究概览
地位
条件
详细说明
Chronic primary pain is highly prevalent among adults with histories of intimate partner violence (IPV), and existing behavioral pain treatments often perform poorly in this population because they do not address trauma-related mechanisms driving chronic pain in this population. Standard MBCT targets two pain-maintaining mechanisms - pain catastrophizing (PCS) and movement avoidance/kinesiophobia (TSK), but does not directly address trauma-related avoidance or include trauma-informed safety features.
MBCT-TIP retains MBCT's core pain-focused components and adds trauma-informed content aimed at trauma-related avoidance (measured via the Posttraumatic Avoidance Behavior Questionnaire (PABQ)).
By integrating MBCT-TIP into primary care, the most common point of contact for adults with chronic pain and IPV histories, this work has the potential to reduce pain interference and post-traumatic stress symptoms in a highly prevalent, often undertreated population
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Rose M Olson, MD, MPH
- 电话号码：617-983-7000
- 邮箱：rolson@bwh.harvard.edu
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02467
- Brigham and Women's Fish Center for Women's Health
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接触：
- Rose M Olson, MD, MPH
- 电话号码：617-983-7000
- 邮箱：rolson@bwh.harvard.edu
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首席研究员：
- Rose M Olson, MD, MPH
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 or older
- Primary care patient at Fish Center or other Mass General Brigham (MGB) primary care clinic
- Diagnosis of chronic primary pain (≥3 months), per ICD-11 criteria
- Pain severity of ≥4 on the Numeric Pain Rating Scale (NRS)
- History of intimate partner violence (IPV), e.g., via the Abuse Assessment Screen (AAS)
Exclusion Criteria:
- Significant change in psychiatric medication or therapy in the past 3 months
- Untreated or poorly controlled severe mental health disorder(s)
- Active or high suicide risk in the past 90 days (via PHQ-9 item #9 or otherwise reported, with subsequent risk assessment as needed)
- Untreated or poorly controlled PTSD, as assessed by the Primary Care PTSD Screen or clinically by the primary care provider (PCP) or consulting psychiatrist
- Untreated or poorly controlled substance use disorder that, per patient self-report or the primary care team, would interfere with the ability to participate
- Moderate-to-severe cognitive impairment or inability to provide informed consent
- Inability to consistently participate in sessions
- Lack of verbal and written English fluency
- Otherwise deemed by referring PCP to be inappropriate for inclusion
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP)
MBCT-TIP will consist of 8 weekly group sessions (final session duration/delivery format to be determined from Aim 1 - Focus Group Discussion and Qualitative analysis).
We will use the ADAPT-ITT framework to identify trauma-specific adaptations to MBCT.
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MBCT-TIP (MBCT for Trauma-Informed Pain)-a primary-care intervention for adults with chronic primary pain and IPV histories-retaining MBCT core elements while adding trauma-specific content to improve effectiveness and feasibility/acceptability.
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有源比较器：Health Enhancement Program (HEP)
Health Enhancement Program (HEP) is an evidence-based intervention consisting of 8 weekly group-format sessions, each lasting 1 hour.
It has been validated in previous studies for testing the efficacy of mindfulness-based interventions (MBIs) while focusing on non-mindfulness goals such as physical activity, sleep, nutrition, and social support.
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Health Enhancement Program (HEP) is an evidence-based intervention consisting of 8 weekly group-format sessions, each lasting 1 hour.
It has been validated in previous studies for testing the efficacy of mindfulness-based interventions (MBIs) while focusing on non-mindfulness goals such as physical activity, sleep, nutrition, and social support.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain interference
大体时间：Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
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Change in pain interference as measured by the PROMIS Pain Interference Scale, which assesses the degree to which pain interferes with daily activities over the past 7 days.
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Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)
大体时间：Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
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Change in post-traumatic stress symptom severity as measured by the PTSD Checklist for DSM-5 (PCL-5), which assesses symptoms of re-experiencing, avoidance, and arousal/reactivity.
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Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2026P001804
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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