Effect of a stepped-care trauma rehabilitation programme for migrants in Germany: the ‘NAT counselling intervention’ study protocol for a naturalistic parallel group trial with a regression discontinuity design for quasi-randomization

Asylum seekers who arrive in their host countries worldwide present with an alarming burden of trauma and distress. Related mental ill health is a matter of concern and hinders the mobilisation of resources necessary for successful social adaptation and integration into host communities, creating a vicious cycle. Although effective treatment is available, services are only accessible when conditions become chronic and/or life-threatening. To overcome the manifold barriers to care, we aim to implement a screen-to-counsel, stepped-care trauma rehabilitation programme for asylum seekers upon arrival in Germany. Individuals are invited to a personal interview at the end of which they are offered a specific intervention, depending on the severity of their symptoms and level of support needed: [s1] watchful waiting; [s2] Narrative Trauma Work (NAT), adapted from Narrative Exposure Therapy (NET; Schauer, Neuner, Elbert, 2025), delivered by peer migrant counsellors; or [s3] treatment by a licensed clinical psychological expert. This study is initiated to assess the effectiveness of the NAT intervention and the sustainability of the overall program within in the German health service setting. To assess the effect of NAT, we will apply a quasi-experimental parallel group study with a natural waiting list control group (regression discontinuity design). Follow-up assessments will be conducted continuously up to 12 months later, in person and online. The outcomes of the study will include symptoms of depression, anxiety and posttraumatic stress, using the Refugee Health Screener (RHS-15, primary outcome). The study will also assess social and economic integration, and resilience, as well as successful application of the NAT counselling intervention, amongst other measures. Cost-effectiveness and sustainability will be assessed for the overall programme. Sustainability will be measured on the basis of counsellor participation and satisfaction using a mixed methods approach. The study will be conducted at various selected sites in southwest Germany. This study addresses a crucial gap in mental health care provision and integration support for refugees and strategic decisions for its implementation. Moreover, the programme builds on the work and evidence for trauma-focused treatment in refugee samples in low-income countries, but also from internally displaced persons and trauma-exposed individuals in post-conflict settings. ClinicalTrials.gov Identifier: DRKS00033410, January 29, 2024. Protocol version: 1.0, Dec 13, 2024; Planned first recruitment: Apr 1st, 2024; Planned completion: unspecified.