B.R.E.A.S.T. Study protocol: Benefits of R-TEP EMDR protocol in Addressing diStress and Trauma in breast cancer...

Breast cancer diagnosis and surgical treatment can be experienced as traumatic events, triggering psychological distress including anxiety, depression, and post-traumatic symptoms. The Recent Traumatic Episode Protocol (R-TEP), an early EMDR intervention, has shown efficacy in reducing psychological symptomatology following recent traumatic events.

This protocol describes a randomized controlled trial designed to assess the efficacy of the EMDR R-TEP protocol in primarily reducing psychological distress and post-traumatic symptoms in breast cancer patients undergoing surgery, with secondary focus on emotion regulation, hopelessness, body image and global psychological symptomatology.

A prospective, longitudinal, single-blind randomized controlled trial will be conducted at the Breast Unit of ASST Rhodense (Milan, Italy). A minimum of 122 female patients, accounting for 20% attrition, with first breast cancer diagnosis scheduled for surgery will be randomized into three groups: treatment as usual (TAU), TAU plus psychoeducational intervention, and TAU plus EMDR R-TEP. Assessments will be conducted at baseline (pre-surgery), post-surgery/pre-psychological intervention, post-psychological intervention, and at 3-month follow-up. Primary outcomes include the Psychological Distress Inventory-Revised and Post-Traumatic Symptom Questionnaire.

This protocol provides the methodological framework for generating evidence on EMDR R-TEP as an early psychological intervention for breast cancer patients.