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University of Copenhagen Competence Centre For Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services in the Capital Region of Denmark ​ Maja Sticker Nordbrandt 1, Erik Lykke Mortensen 2, Jessica Carlsson 1,2 ​ 1 Competence Centre For Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services in the Capital Region of Denmark ​ 2 University of Copenhagen ​ A randomised controlled trial examining the effect of physical activity as add-on treatment for traumatised refugees. ​ Adding physical activity to standard psychiatric treatment for traumatised refugees might improve the mental health, quality of life and functioning of this patient group. ​ METHOD ​ The study included 338 patients in the period from September 2013 to September The patients were randomised into 3 groups: all 3 groups received psychiatric treatment as usual (TAU). TAU consisted of 6 months of consultations and medical treatment by a medical doctor (according to best clinical practice) + manual-based cognitive behavioural therapy by a psychologist. One group received TAU only. ​ The two other groups were assigned to a combination of TAU and add-on treatment consisting of either Basic Body Awareness Therapy or mixed physical activity respectively. Each physical activity was offered for 20 weeks, 1 hour/week and was provided individually. ​ The endpoints of the study were symptoms of PTSD, depression and anxiety as well as quality of life, functional capacity, coping with pain, body awareness and physical fitness. ​. ​ BACKGROUND Treatment of traumatised refugees is one of the fields of psychiatry with the least scientific knowledge (Hetrick et al 2010, Lawrence et al 2010). This leads to impaired quality of treatment and potentially lowers the quality of life for the patients (Lund et al 2008). ​ Chronic pain is very common among traumatised refugees, and it is believed to maintain the mental symptoms of trauma (Sharp 2001). ​ Treating chronic pain is therefore believed to be of high clinical value. In clinical studies, physical activity has shown a positive effect on psychiatric illnesses such as depression and anxiety as well as for patients with chronic pain (Richards 2002). However, scientific knowledge about physical activity as part of the treatment for traumatised refugees is very limited and no national or international guidelines exist on this topic (Lund et al 2008). ​ Author for correspondance: ​ Maja Sticker Nordbrandt, MD ​ Competence Centre for Transcultural ​ Psychiatry, ​ Mental Health Centre Ballerup ​ Maglevænget 2 ​ 2750 Ballerup ​ Tel ​ ​ Design of the study ​ A randomised controlled trial, parallel group superiority study with an allocation ratio of 1:1:1. INTRODUCTION The present study examines the effect of physical activity as add-on treatment for traumatised refugees. This has not yet been done in a randomised controlled setting on such a large scale before. Through its results we expect the study to have an impact on the quality and scope of future treatment for traumatised refugees. PROJECT STATUS The study is in its final phase and inclusion has been completed. Inclusion completer (n=338). Currently the last included patients are being treated. The results of the project are expected to be ready for presentation in OBJECTIVES To examine the differences in treatment outcome of patients treated respectively with or without physical activity as an add-on treatment to psychiatric treatment as usual (TAU); To study if BBAT has a higher impact on the outcome measures compared to mixed physical activity; To investigate if an increase in physiological parameters such as strength, endurance, balance and coordination correlates with an improvement in mental health; To examine if the number of hours spent on home exercises with the planned physical activity is a positive predictor of the treatment effect. N = 338 patients The study is including approximately 310 patients in the period from September 2013 to September The patients are being randomised into 3 groups: all 3 groups receive psychiatric treatment as usual (TAU). TAU consists of 6 months of consultations and medical treatment by a medical doctor (according to best clinical practice) + manual- based Cognitive Behavioural Therapy by a psychologist. One group receives TAU only. The two other groups are assigned to a combination of TAU and add-on threatment consisting of either Basic Body Awareness Therapy or mixed physical activity respectively. Each physical activity is offered for 20 weeks, 1 hour/week and is provided individually. The endpoints of the study are symptoms of PTSD, depression and anxiety as well as quality of life, functional capacity, coping with pain, body awareness and physical fitness.