A Primary Care-Based Adaptation of MBCT for Chronic Pain After Intimate Partner Violence (MBCT-TIP): A Development and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pain interference
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) (Behavioral)
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.
干预措施: Health Enhancement Program (HEP) (Behavioral)
结局指标
主要结局
Pain interference
时间窗: Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
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.
次要结局
- Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)(Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up)
研究者
Rose M, Olson
Instructor
Brigham and Women's Hospital