Empowerment, Acceptance, and Skill Enhancement for Endometriosis (EASE-ENDO): A Mind-Body Virtual Group Intervention for Endometriosis-Associated Pain

PROJECT SUMMARY Endometriosis, a chronic inflammatory disease affecting millions of people worldwide, significantly impacts whole person health. Symptoms primarily center around chronic pain (e.g., pelvic pain, dysmenorrhea, dyspareunia). Additionally, ~50% experience infertility and ~95% have comorbid medical (e.g., migraines, fibromyalgia, GI issues) and/or psychiatric conditions (e.g., depression, anxiety). Endometriosis-associated pain (EAP) disrupts physical activity, work, and relationships. Due to symptom heterogeneity and limited research, EAP is referred to as the “missed disease.” Diagnosis takes on average 7-12 years, ~75% are misdiagnosed, no cure exists, and biomedical treatments are inadequate (~50% do not improve or have recurrent pain). Normalization of symptoms (e.g., “just period cramps”) can reduce help-seeking and lead to social isolation and, in turn, pain. In recognition of this gap, in 2024, the NIH and White House both called for more research in endometriosis and related conditions. This R34 is a timely and innovative project that seeks to develop a tailored mind-body virtual intervention for patients with EAP. Given the biopsychosocial complexity of EAP, this work aims to advance more integrative healthcare. Specific Aims. Our goal is to develop, refine, and test the feasibility and acceptability of a novel, live video, mind-body group intervention for EAP: Empowerment, Acceptance, & Skill Enhancement for Endometriosis (EASE-ENDO). This 8-session group intervention will integrate and tailor evidence-based skills from Acceptance & Commitment Therapy (ACT) and Dialectical Behavior Therapy (DBT), delivered through an empowerment-based lens, to address the unique needs of patients with EAP including chronic pain, emotional distress, and social isolation. We hypothesize that EASE-ENDO will be feasible and acceptable and ultimately improve pain interference, pain intensity, and quality of life by enhancing psychological flexibility, adaptive coping, and social connection. Approach. Informed by the NCCIH research framework, we will: (1) develop EASE-ENDO using our preliminary work and qualitative feedback from patients (N=4 focus groups, 4-6/group; individual exit interviews); (2) optimize EASE-ENDO through an open pilot (Aim 2; N=2 groups; 5-7/group) with pre/post assessments and individual exit interviews; and (3) test EASE-ENDO for feasibility and acceptability in a pilot randomized clinical trial (N=8 groups; 5-7/group), comparing EASE-ENDO with a time- and attention-matched Health Education Control group. Findings will directly inform an R01 multisite feasibility trial and future R01 efficacy-effectiveness and mechanistic trials. Relevance to NCCIH. This R34 directly aligns with funding priorities to improve whole person health and complementary and integrative management of pain. It also fits with the NIH Notice of Special Interest (NOT-OD-24-079). Impact. EASE-ENDO is an innovative and critically needed intervention that has the potential to: (1) improve health outcomes for patients with EAP; (2) enhance the quality and reach of EAP care; (3) decrease healthcare costs associated with EAP and inadequate treatments; and (4) help lead the way for more integrative, patient-centered healthcare.