RECONNECT - Treatments for Complex PTSD

Complex post-traumatic stress disorder (CPTSD) was introduced as a distinct diagnosis in the 11th revision of the International Classification of Diseases (ICD-11). CPTSD includes the core symptoms of post-traumatic stress disorder (PTSD)-re-experiencing, avoidance, and a persistent sense of current threat-as well as disturbances in self-organization (DSO). DSO symptoms comprise affective dysregulation, negative self-concept, and difficulties in relationships. CPTSD is frequently associated with prolonged or repeated trauma and may involve substantial functional impairment, dissociation, interpersonal difficulties, self-harm, and an increased risk of suicide. Although CPTSD is associated with considerable clinical burden, evidence regarding its optimal treatment remains limited. No single psychological treatment has been established as the preferred evidence-based intervention for all patients with CPTSD. The heterogeneity of CPTSD also suggests that treatment response may vary according to patients' clinical characteristics. Research is therefore needed both to compare potentially effective treatments and to identify factors that may inform future treatment selection. Interventions Prolonged Exposure (PE) is an established trauma-focused psychological treatment for PTSD and is recommended in international clinical guidelines. However, evidence regarding its effectiveness specifically for CPTSD remains limited. Eye Movement Desensitization and Reprocessing (EMDR) is also recommended for PTSD and has shown promising results among patients with complex trauma presentations, including dissociative symptoms and trauma related to sexual abuse. Preliminary studies indicate that EMDR may also be effective for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) was developed specifically for CPTSD. It is a modular treatment comprising four components that address PTSD symptoms, emotion regulation, negative self-concept, and interpersonal difficulties. The modular structure allows the clinician and patient to determine the order and emphasis of the treatment components according to the patient's needs. \### Objectives The primary objective is to compare the effectiveness of individual PE, EMDR, and ESTAIR among adult psychiatric outpatients with a primary diagnosis of CPTSD. The primary outcome is CPTSD symptom severity. Secondary outcomes include quality of life, dissociation, interpersonal difficulties, and emotion-regulation difficulties. The study will also explore whether baseline patient characteristics predict treatment outcomes or moderate the comparative effects of the three interventions. Hypothesis The primary hypothesis is that ESTAIR and EMDR will each be non-inferior to PE, which represents treatment as usual, in reducing CPTSD symptoms. CPTSD symptoms are measured using the International Trauma Questionnaire (ITQ) from baseline to post-treatment and at the 6-month follow-up. The predefined non-inferiority margin is 6 points on the ITQ. Study Design RECONNECT is an investigator-initiated, multicenter, randomized, assessor-blinded, three-arm, non-inferiority clinical trial. A total of 315 adults aged 18-65 years with a primary diagnosis of CPTSD will be recruited from three outpatient clinics within the Danish Mental Health Services. Participants will be randomly allocated in equal proportions to one of three individual psychological treatments: * Prolonged Exposure (PE) * Eye Movement Desensitization and Reprocessing (EMDR) * Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) Each intervention consists of 18 weekly individual sessions lasting approximately 60 minutes. Outcomes will be assessed at baseline, during treatment, immediately after treatment, and at follow-up. Outcome assessors will be blinded to treatment allocation.