Chronic PainMBCT-TIPNCT07700355
Mindfulness Therapy for Chronic Pain After Intimate Partner Violence
A study testing Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) and Health Enhancement Program (HEP) in people with Chronic Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) and Health Enhancement Program (HEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Inability to consistently participate in sessions
- Lack of verbal and written English fluency
- Otherwise deemed by referring PCP to be inappropriate for inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Fish Center for Women's Health
Boston, Massachusetts, 02467
Rose M Olson, MD, MPH, 617-983-7000, rolson@bwh.harvard.edu
Rose M Olson, MD, MPH
About this study
Official title: 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:
Read more
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
Read the 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
- Conditions
- Chronic Pain
- Being tested
- Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP), Health Enhancement Program (HEP)
- 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
- Medical subject headings
- Chronic Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Enhancement Program (HEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startJul 2027 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose M, Olson, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700355
- Sponsor's protocol ID
- 2026P001804
- Acronym
- MBCT-TIP
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive population.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary Care-Based Adaptation of MBCT for Chronic Pain After Intimate Partner Violence (MBCT-TIP): A Development and Feasibility Study
- ClinicalTrials.gov ID
- NCT07700355
- Acronym / sponsor ID
- MBCT-TIP / 2026P001804
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Intimate Partner Violence, mindfullness, Therapy, Trauma Informed care, Trauma, Primary care, Primary care based therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) | Experimental | Behavioral: 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. |
| Health Enhancement Program (HEP) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) |
| 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. | Behavioural | Health Enhancement Program (HEP) |
Primary outcome
Pain interference
Time frame: 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.
1 secondary outcome
Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. Sensitive population.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy for Trauma-Informed Pain (MBCT-TIP) and Health Enhancement Program (HEP) in people with Chronic Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rose M Olson, MD, MPH (617-983-7000, rolson@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference (time frame: Change from Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.