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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Rose M Olson, MD, MPH
- 電話番号：617-983-7000
- メール：rolson@bwh.harvard.edu
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02467
- Brigham and Women's Fish Center for Women's Health
-
コンタクト：
- Rose M Olson, MD, MPH
- 電話番号：617-983-7000
- メール：rolson@bwh.harvard.edu
-
主任研究者：
- Rose M Olson, MD, MPH
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain interference
時間枠：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.
|
Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)
時間枠：Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
|
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.
|
Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2026P001804
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。