Internet based versus face-to-face transdiagnostic treatment for emotional disorders in Arabic- and Farsi-speaking refugees: Study protocol of a three-arm randomized controlled non-inferiority trial.

Abstract Background Refugee populations have an increased risk for mental disorders, such as depressive, anxiety, and posttraumatic stress disorders. Comorbidity is common. At the same time, refugees face multiple barriers to accessing mental health treatment. Only a minority of them receives adequate help. The planned trial evaluates a low-threshold, transdiagnostic Internet based treatment. The trial aims at establishing its efficacy and cost-effectiveness compared with face-to-face treatment and no treatment. Methods In a three-arm, multi-site randomized-controlled trial we will test the non-inferiority of the Internet based, cognitive-behavioral treatment to content-equivalent face-to-face treatment and its superiority to waitlist control. N = 499 treatment-seeking Arabic- or Farsi-speaking patients, meeting diagnostic criteria for a depressive, anxiety, and/or posttraumatic stress disorder will be randomized to one of three groups. The first group receives an Internet based treatment with weekly written guidance provided by Arabic- or Farsi-speaking professionals. The second group will receive weekly face-to-face treatment provided by German-speaking CBT therapists and facilitated by interpreters. The third group will wait for three months and then receive their treatment of choice. Both active treatments are based on the Common Elements Treatment Approach (CETA), are tailored to the individual patient, and take 6–16 weeks. Discussion The planned trial will result in an estimate of the (comparative) efficacy of two valuable treatment options for the most common mental disorders in refugees. Trial registration The trial was registered at GCTR, the German clinical trials register, as DRKS00024154 on 2021-02-01.