Chronic Pain
Conditions
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
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
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
Interventions
BEHAVIORALMindfulness-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.
BEHAVIORALHealth 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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain interference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Traumatic Stress - PTSD Checklist for DSM-5 (PCL-5) | Baseline (pre-treatment), post-treatment (approximately 8-10 weeks), and 3-month follow-up | 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. |
Countries
United States
Contacts
CONTACTRose M Olson, MD, MPH
Outcome results
None listed