The Randomized control trial as a research tool in torture rehabilitation

1. The Randomizedcontrol trial as aresearch tool intorture rehabilitation Andrea Northwood, PhD, and Maria Vukovich, PhD Center for Victims of Torture, Minnesota USA

2. Research and clinical staff of the HealingHearts Project

3. Definition of Terms RCT (Randomized Control Trial) A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the effect of the experimental treatment.1 See handout for definitions of other common terms in research design

4. RCT • “Gold standard” because the design itself reduces bias when testing effects of an intervention.1 • Randomization creates two (or more) groups of persons that are probabilistically similar to each other. This is critical because it allows the effects of treatment to be isolated from alternative explanations about differences observed between intervention and control groups (causality).1 • Blindness of outcome assessor to group assignment is equally important

5. THE OTHER RCT IN TORTURE REHABILITATION… • Not many studies 2, 5 • Small sample sizes (n) 3, 5 • Uneven distribution of group sizes 3, 5 • Usually compare types of counseling 2, 5 • Multiple calls for more rigorous methods (random assignment, meaningful control groups, etc.) 2, 3, 4, 5 • Increasingly influential paradigm: do we want to influence it?

6. Good reasons why the rct is rarely used • History of movement tied to human rights advocacy 3 • Vulnerabilities of the population 2,3 • Heterogeneity of refugee groups 3, 4 • Fluidity of culture & residence for people on the move 2, 3

7. Good reasons why the rct is rarely used • Complexity of presenting problems & treatment environment 2, 3, 4 • Resources needed (time, $, technical) 3 • Our own biases and fears 3

8. Why did we use it? • Power of the design, AND • Years of observation of refugees arriving at our clinic later than asylum seekers, in worse shape, AND • Years of program evaluation that allowed us to estimate the required n, AND • Health care reform in U.S. created certain funding opportunities • Integrated care at primary health clinics • Studies examining cost reduction for those with complex needs

9. KarenPeople in Minnesota

10. Lands of origin

11. Levels of Distress for New Arrivals in U.S. • Severity of trauma (high)6,7 • Base rates of torture (high)8,9 • Duration of migration (long)10,11

12. Levels of distress (CONT) • Similarity between culture of origin and culture of resettlement (low)

13. Levels of distress (CONT) • Social support systems • Previous waves of arrivals have paved the way

14. RCT as part of a mixed methods study • Referral into the study comes from primary care physician • Criteria include: Karen; Major Depression; Adult; <5 yrs in U.S. • Random assignment into CVT treatment (Intervention Group) or Treatment as usual (Control Group) • Intervention lasts a year, consisting of individual psychotherapy and “targeted case management” from CVT clinicians. Each IG member has a therapist and a case manager from CVT. These weekly services are delivered at the primary care clinic. • Quantitative assessments of symptoms (depression, anxiety, somatic, PTSD) and adaptive functioning at intake, 3, 6, 12 months • Qualitative client interview on culture-specific aspects of health & U.S. health care experiences at 1 year

15. Questions 1. Is this CVT intervention more effective than care-as-usual in reducing common post-trauma symptoms and improving adaptive functioning for this population? 2. Will this treatment model generate cost savings and/or better utilization of health care services compared to care-as-usual for this population?

16. Locations of the study

17. What has gone well • Integration of research and “real-world” clinical service provision • Maintaining high ethical standards & low attrition • Preserving RCT design • Control group has remained a real-world control group (care-as-usual) • Strong project management & fundraising; strong institutional support; strong clinic relationships

18. challenges • Structural challenges at the clinics and with insurance companies • Cultural differences between mental health and primary medical care professionals • Access to patients (improved early on after we hired a Karen logistics coordinator) • Ebb & flow of arrivals • Staff attrition

19. RCT design ambivalence • Ethical in a given context? • Cost prohibitive? • Reinforces one way of knowing as the only way of knowing? • Designed with relevance to real-world practice? • Limited stakeholder buy-in from clinicians or clinics? • Patience for enduring a long period of impact on a clinic before results are in?

20. Expected impact • Better evidence base for our work • Different foci than other studies • Springboard for program development and reaching more survivors in need (e.g. Atlanta Thrive) • Access to new platforms/audiences, fields, funders/revenue sources • Stronger dissemination potential

21. References 1Shadish, W., Cook, T., and Campbell, D. (2002). Statistical Conclusion Validity and Internal Validity. In: Experimental and Quasi Experimental Designs for Generalized Causal Inference. Shadish, W., Cook, T., and Campbell, D. (Eds). Boston, MA: Houghton Mifflin, p. 33-63. 2 Slobodin, O., & de Jong, J. (2015) Mental health interventions for traumatized asylum seekers and refugees: What do we know about their efficacy? InternationalJournal of Social Psychiatry 61(1), 17-26. 3 Carlsson, J., Sonne, C., & Silove, D. (2014) From Pioneers to Scientists: Challenges in establishing evidence-gathering models in torture and trauma mental health services for refugees. Journal of Nervous and Mental Disease, 202(9), 630-637. 4 McFarlane, C., & Kaplan, I. (2012) Evidence-based psychological interventions for adult survivors of torture and trauma: A 30-year review. Transcultural Psychiatry, 49(3-4), 539-567. 5 Patel et al., 2014. Psychological, social and welfare interventions for psychological health and wellbeing of torture survivors. Cochrane Database of Systematic Reviews, 11, CD009317. DOI: 10.1002/14651858.CD009317.pub2. 6 Cook, T., Shannon, P, Vinson, G., Letts, J., Dwee, E. (2015) War trauma and torture experiences reported during public health screening of newly resettled Karen refugees: A qualitative study. BMC International Health & Human Rights, 15:8, 1-13.

22. References 7 Karen Women’s Organization. (2007) State of terror: The ongoing rape, murder, torture, and forced laboursuffered by women living under the Burmese military regime in Karen State. https://karenwomen.files.Wordpress.com/2011/11/state20of20terror20report.pdf. Accessed Nov 10, 2016. 8 Schweitzer, R.D., Brough, M., Vromans, L., Asic-Kobe, M. (2011). Mental health of newly arrived Burmese refugees in Australia: Contributions of pre-migration and post-migration experience. AustNZ Journal of Psychiatry, 45, 299-307. 9 Shannon, P. J., Vinson, G., Wieling, L., Cook, T., Letts, J. (2014) Torture, war trauma, and mental health symptoms of newly arrived Karen refugees. Journal of Loss and Trauma: International Perspectives on Stress and Coping. 0:1-14. Published online first: Sept 15. doi:10.1080/15325024.2014.965971 10 UNHCR (2015). Forced Migration and the Myanmar Peace Process. Retrieved from: http://www.unhcr.org/54f588cb9.pdf 11 Karen Human Rights Group (2014). ‘Truce or Transition: Trends in human rights abuse and local response in Southeast Myanmar since the 2012 ceasefire.’ Retreived from: http://www.khrg.org/2014/05/truce-or-transition-trends-human-rights-abuse-and-local-response