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
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rose M Olson, MD, MPH
- 전화번호: 617-983-7000
- 이메일: rolson@bwh.harvard.edu
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02467
- Brigham and Women's Fish Center for Women's Health
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연락하다:
- Rose M Olson, MD, MPH
- 전화번호: 617-983-7000
- 이메일: rolson@bwh.harvard.edu
-
수석 연구원:
- Rose M Olson, MD, MPH
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain interference
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026P001804
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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