Mindfulness Therapy for Chronic Pain After Intimate Partner Violence

NCT07700355 | Not Yet Recruiting

• 1 other identifier: 2026P001804
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Keywords

Chronic Pain; Intimate Partner Violence; mindfullness; Therapy; Trauma Informed care; Trauma; Primary care; Primary care based therapy; Mindfulness-based cognitive therapy; Mind-body intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)

  Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up

Study Arms (2)

Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP)

EXPERIMENTAL

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)

Health Enhancement Program (HEP)

ACTIVE COMPARATOR

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)

Interventions

Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) BEHAVIORAL

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.

Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP)

Health Enhancement Program (HEP) BEHAVIORAL

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Fish Center for Women's Health

Boston, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Chronic Pain; Wounds and Injuries

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Rose M Olson, MD, MPH

CONTACT

617-983-7000; rolson@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Aim 2 (Single Group): We will conduct a single-arm, open pilot study of MBCT-TIP, with all participants receiving the intervention. Aim 3 (Parallel): We will conduct a pilot feasibility RCT comparing MBCT-TIP to an active control, the Health Enhancement Program (HEP).

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)