Treatment of traumatised refugees: the effect of Basic Body Awareness Therapy versus mixed physical activity as add-on treatment – A Randomised Controlled Trial (PTF4)

​1. Title: 

Treatment of traumatised refugees: the effect of Basic Body Awareness Therapy versus mixed physical activity as add-on treatment – A Randomised Controlled Trial (PTF4) 

2. Project period: 

The inclusion period has taken place since September 2013 and is expected to be complete by autumn 2015. 

3. Investigator: 

Maja Sticker Nordbrandt, MD, PhD student 

4. Supervisors and collaborative partners 

  • Senior Consultant Jessica Carlsson, PhD (CTP) (primary supervisor). 
  • Professor Erik Lykke Mortensen, University of Copenhagen (supervisor). 
  • Associate Professor Jonna Anne Jensen, Metropolitan University College, Denmark (collaborative partner). 
  • Professor Derrick Silove, Psychiatry Research & Teaching Unit, Liverpool Hospital, University of New South Wales, Australia (collaborative partner). 
  • Executive director Jorge Aroche, The New South Wales Service for the Treatment and Rehabilitation of Torture and Trauma Survivors (STARTTS), Australia (collaborative partner). 

5. Background 

Chronic pain is commonly comorbid to PTSD(1–5). According to the well-established “Mutual Maintenance Theory” there is a mutual maintenance of PTSD and chronic pain, and the treatment of chronic pain plays a central role in improving the treatment and wellbeing of patients with PTSD(3). Nevertheless, there is a lack of knowledge about how to treat chronic pain in traumaaffected refugee populations. The project is motivated by this important gap. The effects of physical activity on other psychiatric illnesses than PTSD have been examined(6–13). Regarding depression, which is often comorbid to PTSD(14–19), the evidence suggests small or moderate effects of physical activity(16,20,21). Importantly, positive effects of physical activity have also been seen for chronic pain(22–30). However, scientific knowledge about physical activity as part of the treatment for traumatised refugees is rather limited and no national or international guidelines exist on this topic(31–33). Despite this gap, different types of physical activity are often used as part of the treatment for this group of patients. 

There are a few randomised controlled trials on traumatised refugees with PTSD, which had physical activity as the intervention. Among these, one small randomised controlled trial from 2011 by Liedl et al., suggesting specifically that physical activity adds value to pain management for traumatised refugees (34). Another type of physical activity which has been studied as intervention in a number of trials on other illnesses such as chronic pain, fibromyalgia, schizophrenia, personality disorders and non-specific musculoskeletal disorders is Basic Body Awareness Therapy (BBAT) (9,11,24– 26,35). In order to test the feasibility of BBAT on a group of traumatised refugees, a pilot study was conducted in 2012 (36) at the Competence Centre for Transcultural Psychiatry (CTP). The participants showed high acceptability, compliance and satisfaction with BBAT (36). The present study has been inspired by the preliminary results of these two abovementioned studies.

As in the case of depression, the working mechanisms behind the effect of physical activity on PTSD symptoms are unclear. The Cochrane review; ”Sports & Games for post-traumatic stress disorder” from 2010 concludes: “Randomised controlled trials assessing the effect of sport and game interventions are needed to inform the current practice of using sports and games to improve symptoms of PTSD”. In line with this, there is a need for more systematic research examining a number of unsolved issues: 1) the effectiveness of physical activity as a remedy for symptoms of PTSD and chronic pain; 2) the relative benefits of different types of physical activity; 3) whether group or individual physical activity is the most efficient; 4) the optimum duration and intensity of physical activity. 

6. Aims 

  1. To examine whether physical activity as an add-on treatment to psychiatric treatment as usual, gives an increased effect compared to psychiatric treatment as usual in mental symptoms (PTSD, depression and anxiety), quality of life, functional capacity, coping with pain and body awareness. 
  2. To examine, whether an increase in physiological parameters such as strength, endurance, balance and coordination correlates with an improvement of PTSD, anxiety, depression, coping with pain, quality of life, functional capacity as well as body awareness. 
  3. To examine if the number of hours spent on home exercises in the specific assigned physical activity is a positive predictor of the treatment effect. 
  4. To examine if Basic Body Awareness Therapy (BBAT) has a higher impact on mental symptoms (PTSD, depression, anxiety), coping with pain, quality of life, functional capacity, and body awareness, compared to mixed physical activity. 

7. Methods 

7.1 Number of participants 

(N) 288 (min. 200 are expected to complete the trial in accordance with the protocol). 

7.2 Population 

Patients referred to treatment for PTSD at CTP from September 2013 to August 2015; aged 18 or older; refugee or family reunified with a refugee; diagnosed with PTSD pursuant to the ICD10 research criteria; psychological trauma in the anamnesis; estimated by a medical doctor to be motivated for treatment; provide written informed consent. 

7.3 Description of data and data collection 

The patients are randomised into three groups. All three groups receive psychiatric treatment as usual (TAU). TAU consists of 6-7 months of medical treatment according to best clinical practice in the field and manual-based Cognitive Behavioural Therapy. While one of the three groups is a control group and solely receives TAU, the two other groups receive add-on treatment with physical activity. One of the groups is assigned to Basic Body Awareness Therapy (BBAT) (a method focusing on breathing, posture and body awareness) while the other group is assigned to mixed physical activity (MPA), which focuses on exercises of strength, endurance, balance and coordination. For all three groups the treatment period is around 6-7 months.

The patients will fill out self-administered ratings three times during the treatment period: one at the pre-treatment consultation (baseline), one halfway through the treatment (before the first psychotherapy session) and one just after completing the treatment. Furthermore, there are ratings and tests specifically related to the physical activity at the beginning and at the end of the treatment programme. Trained medical students carry out blinded observer-ratings of depression and anxiety at the start and at the end of the treatment programme. The primary endpoint of the study will be symptoms of PTSD, and secondary endpoints will be symptoms of depression, anxiety, and quality of life, functional capacity, coping with pain, body awareness and physical fitness. 

7.4 Application/acceptance from the Danish Data Protection Agency, the National Committee on Health Research Ethics 

Consent for the study has been given both from the Danish Data Protection Agency and the National Committee on Health Research Ethics. 

7.5 Analysis 

Drop-out analysis is based on the patients who show up at the initial referral interview. The patients in the programme will be compared with the patients who were excluded at the referral interview in order to identify possible systematic selection bias. Furthermore, the group of patients included in the trial, but who eventually drop out and do not complete the trial will be analysed. In addition to completer analysis, intention-to-treat analyses will be carried out. 

8. Expected results 

The results of this trial are expected to improve treatment for the individual patient and to stimulate further research within a relatively short time. In the long term, results are expected to be applied in reference programmes and clinical guidelines. This will ensure high quality evidence-based treatment as well as ease the work of practitioners with respect to identifying the appropriate type of treatment for the patient. Furthermore, the trial is expected to generate a socio-economic gain as ineffective treatment programmes are prevented. 

9. Dissemination of results 

Positive as well as inconclusive or negative results will be published. After completion of data analysis, three publications are planned regarding the following aspects of the study: 

  • The effect of physical activity as an add-on treatment to psychiatric treatment as usual for traumatised refugees. 
  • The mental health benefits of a focus on body awareness when treating traumatised refugees with physical activity. 
  • The mental health benefits of improvement of parameters of fitness when treating traumatised refugees with PTSD. 

The results are planned to be presented on national as well as international meetings and conferences of psychiatry. 

10. References

1. Olsen D, Olsen DR. Prevalent musculoskeletal pain as a correlate of previous exposure to torture. Scand J Public Health. 2006;34(5):496–503. 

2. Olsen DR, Montgomery E, Bøjholm S, Foldspang A. Prevalence of pain in the head, back and feet in refugees previously exposed to torture: a ten-year follow-up study. Disabil Rehabil [Internet]. 2007 Jan 30 [cited 2013 Jan 29];29(2):163–71. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17364766 

3. Sharp TJ, Harvey a G. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev [Internet]. 2001 Aug [cited 2013 Feb 2];21(6):857–77. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11497210 

4. Morasco BJ, Lovejoy TI, Lu M, Turk DC, Lewis L, Dobscha SK. The relationship between PTSD and chronic pain: mediating role of coping strategies and depression. Pain [Internet]. 2013 Jan 11 [cited 2013 Mar 12];154(4):609–16. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23398939 

5. Buhmann CB. Traumatized refugees: morbidity, treatment and predictors of outcome. Dan Med J [Internet]. 2014 Aug [cited 2014 Nov 21];61(8):B4871. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25162447 

6. Gyllensten AL, Hansson L, Ekdahl C. Outcome of Basic Body Awareness Therapy. A Randomized Controlled Study of Patients in Psychiatric Outpatient Care. Adv Physiother [Internet]. Informa UK Ltd UK; 2003 Jan [cited 2011 Apr 9];5(4):179–90. Available from: http://informahealthcare.com/doi/abs/10.1080/14038109310012061 

7. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta-analysis. Prim Care Companion CNS Disord [Internet]. Physicians Postgraduate Press, Inc.; 2011 Jan [cited 2012 Mar 10];13(4). Available from: /pmc/articles/PMC3219516/?report=abstract 

8. Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med [Internet]. 2005 Feb [cited 2011 Apr 14];11(1):189–201. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15750381 

9. Hedlund L, Gyllensten AL. The experiences of basic body awareness therapy in patients with schizophrenia. J Bodyw Mov Ther [Internet]. 2010 Jul [cited 2013 Jan 22];14(3):245–54. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20538222 

10. De Moor MHM, Boomsma DI, Stubbe JH, Willemsen G, de Geus EJC. Testing causality in the association between regular exercise and symptoms of anxiety and depression. Arch Gen Psychiatry [Internet]. 2008 Aug;65(8):897–905. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18678794

11. Friis S, Skatteboe UB, Hope MK, Vaglum P. Body awareness group therapy for patients with personality disorders. 2. Evaluation of the Body Awareness Rating Scale. Psychother Psychosom [Internet]. 1989 Jan [cited 2013 Jan 21];51(1):18–24. Available from: http://www.ncbi.nlm.nih.gov/pubmed/2602528 

12. Bräuninger I. The efficacy of dance movement therapy group on improvement of quality of life: A randomized controlled trial. Arts Psychother [Internet]. Elsevier Ltd; 2012 Sep [cited 2013 Jan 30];39(4):296–303. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0197455612000329 

13. Porges SW. The polyvagal theory: phylogenetic substrates of a social nervous system. Int J Psychophysiol [Internet]. 2001 Oct;42(2):123–46. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11587772 

14. Manger TA, Motta RW. The impact of an exercise program on posttraumatic stress disorder, anxiety, and depression. Int J Emerg Ment Health [Internet]. 2005 Jan [cited 2011 Apr 4];7(1):49–57. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15869081 

15. Krogh J, Saltin B, Gluud C, Nordentoft M. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression. J Clin Psychiatry. 2009 Jun;70(6):790–800. 

16. Krogh J, Nordentoft M, Sterne J a C, Lawlor D a. The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials. J Clin Psychiatry. 2011 Apr;72(4):529–38. 

17. Mead G, Morley W, Campbell P, Carolyn A G, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev [Internet]. 2008 [cited 2011 Apr 6];(4):CD004366. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18843656 

18. Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med [Internet]. 2005 Jan [cited 2010 Aug 5];28(1):1–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15626549 

19. Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry [Internet]. 2004 Jan [cited 2010 Dec 6];6(3):104–11. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=474733&tool=pmcentrez&rendertype=abstract 

20. Cooney G, Dwan K, Mead G. Exercise for depression. JAMA [Internet]. American Medical Association; 2014 Jun 18 [cited 2014 Dec 4];311(23):2432–3. Available from: http://jama.jamanetwork.com.ep.fjernadgang.kb.dk/article.aspx?articleid=1881295

21. Danielsson L, Noras AM, Waern M, Carlsson J. Exercise in the treatment of major depression: a systematic review grading the quality of evidence. Physiother Theory Pract [Internet]. 2013 Nov [cited 2014 Nov 26];29(8):573–85. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23521569 

22. Trial AR, Garfinkel MS, Singhal A, Katz WA, Allan DA, Reshetar R, et al. Yoga-Based Intervention for Carpal Tunnel Syndrome. Am Med Assoc. 1998;280(18). 

23. Williams KA, Petronis J, Smith D, Goodrich D, Wu J, Ravi N, et al. Effect of Iyengar yoga therapy for chronic low back pain. Pain [Internet]. 2005 May [cited 2013 Feb 2];115(1- 2):107–17. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15836974 

24. Gard G. Body awareness therapy for patients with fibromyalgia and chronic pain. Disabil Rehabil [Internet]. 2005 Jun 17 [cited 2011 May 5];27(12):725–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16012065 

25. Malmgren-Olsson E, Armelius B, Armelius K. A Comparative outcome study of body awareness therapy, feldenkrais, and conventional physiotherapy for patients with nonspecific musculoskeletal disorders: changes in phychological symptoms, pain and selfimage. Physiother Theory Pract [Internet]. 2001 [cited 2013 Jan 22];17(2):77–95. Available from: http://informahealthcare.com.ep.fjernadgang.kb.dk/toc/ptp/17/2 

26. Malmgren-Olsson E-B, Bränholm I-B. A comparison between three physiotherapy approaches with regard to health-related factors in patients with non-specific musculoskeletal disorders. Disabil Rehabil [Internet]. 2002 Apr 15 [cited 2011 May 5];24(6):308–17. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12017464 

27. Price CJ, McBride B, Hyerle L, Kivlahan DR. Mindful awareness in body-oriented therapy for female veterans with post-traumatic stress disorder taking prescription analgesics for chronic pain: a feasibility study. Altern Ther Health Med [Internet]. NIH Public Access; 2007 [cited 2012 Sep 21];13(6):32–40. Available from: /pmc/articles/PMC3037268/?report=abstract 

28. Carson JW, Carson KM, Jones KD, Bennett RM, Wright CL, Mist SD. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia. Pain [Internet]. 2010 Nov [cited 2011 Jan 27];151(2):530–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20946990 

29. Richards SCM, Scott DL. Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial. BMJ [Internet]. 2002 Jul 27 [cited 2011 Apr 15];325(7357):185. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=117444&tool=pmcentrez&rendertype=abstract

30. King SJ, Wessel J, Bhambhani Y, Sholter D, Maksymowych W. The effects of exercise and education, individually or combined, in women with fibromyalgia. J Rheumatol [Internet]. 2002 Dec [cited 2011 Apr 15];29(12):2620–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12465163 

31. Lawrence S, De Silva M, Henley R. Sports and games for post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev [Internet]. 2010 Jan [cited 2011 Apr 6];(1):CD007171. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20091620 

32. Lund M, Sørensen J, Christensen J, Ølholm AM. MTV om behandling og rehabilitering af PTSD–herunder traumatiserede flygtninge. Region Syddanmark [Internet]. Center for Kvalitet. 2008 [cited 2011 Apr 4]. Available from: http://scholar.google.com/scholar?hl=en&btnG=Search&q=intitle:MTV+om+behandling+og+rehabilitering+af+PTSD?herunder+traumatiserede+flygtninge.+Region+Syddanmark#0 

33. National Institute of Clinical Exellence. Post-traumatic stress disorder (PTSD) The management of PTSD in adults and children in primary and secondary care [Internet]. Clinical Guideline 26, Developed by the National Collaborating Centre for Mental Health. National Institute for Clinical Excellence; 2005 [cited 2011 Apr 7]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK56506/ 

34. Liedl A, Müller J, Morina N, Karl A, Denke C, Knaevelsrud C. Physical Activity within a CBT Intervention Improves Coping with Pain in Traumatized Refugees : Results of a Randomized Controlled Design. Pain Med. 2011;12:234–45. 

35. Danielsson L, Papoulias I, Petersson E-L, Carlsson J, Waern M. Exercise or basic body awareness therapy as add-on treatment for major depression: A controlled study. J Affect Disord [Internet]. 2014 Oct 15 [cited 2014 Sep 26];168:98–106. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25043321 

36. Stade K, Skammeritz S, Hjortkjær C, Carlsson J. “After all the traumas my body has been through, I feel good that it is still working.” –Basic Body Awareness Therapy for traumatised refugees. Torture. 2015;In press. 

Responsible editor
Jesper Kvorning