Background Refugee populations have an increased risk for mental disorders, such as depression, 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 receive 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 no treatment. Methods N = 131 treatment-seeking Arabic- or Farsi-speaking patients, meeting diagnostic criteria for a depressive, anxiety, and/or posttraumatic stress disorder will be randomized to either the intervention or the waitlist control group. The intervention group receives an Internet-based treatment with weekly written guidance provided by Arabic- or Farsi-speaking professionals. The treatment is based on the Common Elements Treatment Approach (CETA), is tailored to the individual patient, and takes 6–16 weeks. The control group will wait for 3 months and then receive the Internet-based treatment. Discussion The planned trial will result in an estimate of the efficacy of a low-threshold and scalable treatment option for the most common mental disorders in refugees. Trial registration German Registry for Clinical Trials DRKS00024154. Registered on February 1, 2021.

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.

Background Refugees are at high risk for developing mental illnesses. Due to language and cultural barriers, there is need for specifically adapted therapeutic procedures for refugees in inpatient mental health care settings. Internet-based applications in refugee mother tongues have the potential to improve the outcomes of mental health care for this vulnerable population. The key research question of the present implementation study is whether the newly developed “blended ALMAMAR” app for Arabic and Farsi speaking refugees in Germany is used and accepted by patients and professionals in routine inpatient mental health care (blended care). Methods We present the design of an observational, prospective multicenter implementation study in eight psychiatric hospitals. We plan to recruit 100 Farsi or Arabic speaking refugees receiving in-patient treatment due to depression, anxiety disorder, posttraumatic stress disorder or substance use disorders. These patients will get access to the “blended ALMAMAR” app during their inpatient stay in a blended-care approach. We will assess the usage (e.g., duration and frequency of use of the app) as well as subjective acceptability and usability of the intervention. To identify sociodemographic and clinical factors associated with “blended ALMAMAR” usage, we will also perform clinical and questionnaire assessments. Discussion The newly developed “blended ALMAMAR” app may help to close communication gaps for the hard-to reach and vulnerable group of refugees in inpatient mental health care. It is the first blended-care intervention that addresses severely mentally ill refugees in an inpatient psychiatric setting in Germany. Trial registration The trial was registered in the German Clinical Trials Register on November 11, 2021 (DRKS00025972) and adapted on November 14, 2023.