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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP); Behavioral: Health Enhancement Program (HEP)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rose M Olson, MD, MPH; Phone Number: 617-983-7000; Email: rolson@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02467
      • Brigham and Women's Fish Center for Women's Health
      • Contact: Rose M Olson, MD, MPH; Phone Number: 617-983-7000; Email: rolson@bwh.harvard.edu
      • Principal Investigator: Rose M Olson, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP); 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain interference	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)	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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Primary care; Therapy; Trauma; Intimate Partner Violence; mindfullness; Mindfulness-based cognitive therapy; Mind-body intervention; Trauma Informed care; Primary care based therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Wounds and Injuries; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Cognitive Therapy
• Other Study ID Numbers: 2026P001804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sensitive population.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No