Mindfulness Therapy for Chronic Pain After Intimate Partner Violence

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07700355
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

First listed
Jul 14, 2026
Start date
Jul 31, 2027
Status verified
Jul 2026
Primary completion
Sep 30, 2030
Completion
Aug 31, 2031

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Pain interference [ Time Frame: Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's Fish Center for Women's HealthBostonMassachusetts02467
Rose M Olson, MD, MPH
[email protected]
617-983-7000
Rose M Olson, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Fish Center for Women's Health· Boston, MA

Related Studies