Mindfulness Therapy for Chronic Pain After Intimate Partner Violence (NCT07700355) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mindfulness Therapy for Chronic Pain After Intimate Partner Violence
United States58 participantsStarted 2027-07
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain interference
Timeframe: Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up