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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rose M Olson, MD, MPH | Contact | 617-983-7000 | rolson@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Fish Center for Women's Health | Boston | Massachusetts | 02467 | United States |
Sensitive population.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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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).
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|
| 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. |
|
| D004191 |
| Behavioral Disciplines and Activities |