Trauma-Affected Refugees Treated with Basic Body Awareness Therapy or Mixed Physical Activity as Augmentation to Treatment as Usual - A Pragmatic, Randomised Controlled Trial

Abstract

Background: The prevalence of post-traumatic stress disorder (PTSD) is estimated to be as high as 30% among refugees. The coexistence of prevalent chronic pain is believed to maintain symptoms of PTSD and add complexity to the condition. Despite this, little evidence exists on how to treat PTSD and its comorbid conditions best in trauma-affected refugees. We aimed to evaluate the effects of physical activity as add-on to psychiatric treatment as usual (TAU) in trauma-affected refugees with PTSD. Method: Adult (≥18 years) trauma-affected refugees were included in a 3- armed randomised controlled trial conducted at Competence Centre for Transcultural Psychiatry, Denmark. It was a parallel group superiority study, stratified for PTSD severity and gender. The allocation ratio was 1:1:1. An open-label design was applied due to the nature of the intervention. All 3 groups received TAU and two groups participated in either Basic Body Awareness Therapy (B) or mixed physical activity (M) as add-on treatment through individual physiotherapy sessions, one hour/week for 20 weeks. The primary outcome was PTSD severity measured by Harvard Trauma Questionnaire (HTQ) (pre- and post-treatment). Findings: Between September 13, 2013 and September 30, 2015, 338 patients were included (C/B/M=110/114/114), of whom 318 patients were eligible for intention-to-treat analysis and 228 for per-protocol analysis (C/B/M=104/63/61). On the primary outcome, intention-to-treat as well as per-protocol analyses showed small but significant improvement on scores from pre- to post-treatment in all three groups but with no significant difference in improvement between groups (mean differences on HTQ between B and C; 0·04 (95% CI -0·11-0·19) and between M and C; 0·00 (95% CI - 0·17-0·17)). Interpretation: The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees. Clinical Trial Registration Number: ClinicalTrials.gov, NCT01955538. Funding Statement: TRYGFonden Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: This study is approved by the Ethics Committee of the Capital Region of Denmark (H-3-2013-080) and by the Danish Data Protection Agency (02481 RHP-2013-024). The trial was monitored by Good Clinical Practice (GCP) Unit at Copenhagen University Hospital during the entire study period.