RECONNECT - Treatments for Complex PTSD

Complex PTSD (CPTSD) is a new diagnosis for which no established gold-standard treatment(s) yet exists. In this trial, three psychotherapies, Prolonged Exposure (PE), Eye Movement Desensitization and Reprocessing (EMDR), and Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR), are compared in a multisite trial. Methods: The study is a single-blinded, pragmatic, non-inferiority, multi-center randomized controlled trial (RCT) comparing ESTAIR, EMDR vs PE for CPTSD, each delivered as 18 weekly individual sessions. In total, 315 patients will be recruited from three outpatient clinics in the Capital Region of Denmark and randomized to one of the three intervention arms. The primary outcome is patient-rated CPTSD symptoms assessed with the International Trauma Questionnaire (ITQ); secondary outcomes include clinician-rated CPTSD symptoms assessed with the International Trauma interview (ITI), as well as dissociation, quality of life, attachment, interpersonal problems, and emotion regulation. Assessments are conducted before and after therapy (18 weekly sessions) treatment and at 6-month follow-up. Weekly patient- and clinician-rated outcomes are collected at every treatment session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, while fidelity assessors will monitor manual adherence.