Moderate-intensity Aerobic Exercise Training as an Adjunct to Trauma-focused Psychotherapy in Traumatized Refugees and Asylum Seekers: Study Protocol of a Randomized Controlled Trial

Abstract

Abstract Background Refugees with exposure to multiple traumatic events are at high risk for developing trauma-related mental disorders, including Posttraumatic Stress Disorder (PTSD) and depression. Narrative Exposure Therapy (NET) is an effective treatment for the core symptoms of PTSD, but many studies did not find that it significantly reduces depressive symptoms. Endurance exercise on the other hand was consistently found to be effective in treating symptoms of depression, thereby making it a promising adjunct to NET. Up to date, no studies exist investigating the combination of NET and endurance exercise in a sample of refugees with PTSD and relevant comorbid depressive symptoms. Methods/ Design In the proposed Randomized Controlled Trial (RCT) we aim to investigate whether a combination of NET and Moderate-intensity Aerobic Exercise Training (MAET) enhances treatment outcome for refugees with PTSD and comorbid depressive symptoms. Therefore, we hypothesized a greater improvement in psychopathology in participants who receive the combined treatment. According to power calculation assuming a moderate adjuvant effect, 68 refugees and asylum seekers with a confirmed PTSD diagnosis and clinically relevant depressive symptoms will be recruited in the proposed study. Participants will be randomly assigned to receive either NET only (NET-group; n = 34) or NET plus MAET (NET+-group; n = 34). All participants will receive ten NET sessions (100 minutes each). Participants in the NET+-group will additionally take part in MAET (running exercises à 45min three times weekly). Primary (PTSD, depression) and secondary (general mental distress, sleep quality, agoraphobia) outcome measures will be assessed before treatment, directly after treatment, and at six-month follow-up. The hypotheses are planned to be tested with multiple 2x3 mixed ANOVA’s. Discussion The proposed study will be the first RCT assessing whether NET, which is currently the first-line treatment for PTSD in refugees, can be enhanced by endurance exercise. If the results will be in line with the hypotheses, the psychotherapeutic care of traumatized refugees with PTSD and comorbid depressive symptoms could be improved. Potential challenges include participant recruitment and retention. Trial registration: The present clinical trial is pre-registered in German Clinical Trials Register (DRKS) on 29 July 2020; DRKS ID: DRKS00022145).