HREGION THE TREATMENT AND RESEARCH INTEGRATED MODEL,TRIM. - How to make the most of your clinical data in a refugee health setting

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1 THE TREATMENT AND RESEARCH INTEGRATED MODEL,TRIM - How to make the most of your clinical data in a refugee health setting Charlotte Sonne, MD, PhD Competence centre for Transcultural Psychiatry (CTP)

2 COMPETENCE CENTRE FOR TRANSCULTURAL PSYCHIATRY 2 Established in 2008 Psychiatric outpatient clinic, part of the Mental Health Services of the Capital Region in Denmark Main patient group: Adult refugees with trauma-related mental health problems Vision: That all refugees with trauma-related mental health problems can be offered evidence-based and effective treatment

3 WHY RESEARCH? 3 There is a lack of knowledge internationally of effective treatment strategies for trauma-affected refugees in several areas: Pharmacological treatment, psychotherapy, physical activity, predictors for treatment outcome etc Research objectives at CTP To contribute with new knowledge regarding treatment To implement this knowledge in clinical practice

4 CHALLENGES IN RESEARCH WITH TRAUMATIZED REFUGEES 4 Many centers origin from the NGO world and haven t been clinical settings from the start Clinicians might worry that trauma-affected refugees are too fragile to participate It can be difficult to standardise treatment across cultures Research can be expensive and steal money from the treatment budget Control groups/placebo could be unethical

5 TRIM - A POSSIBLE SOLUTION 5 TRIM = Treatment and research integrated model => Research integrated in clinical work: Case Report Form integrated in medical record => all clinicians are collecting data in their everyday work, making data collection cheap and easy All researchers are or have been clinicians => know what is doable with this patient group Data collection and data monitoring systematised => cost-effective way of creating a database

6 HOW ARE RESEARCH PROJECTS CARRIED OUT? 6 A chain of clinical studies on the treatment of trauma-affected refugees Which treatment has the best overall results? Which treatment to whom?

7 7 STANDARD RATINGS Symptoms Harvard Trauma Questionnaire (HTQ): PTSD self-rating Hopkins Symptom Checklist (HSCL-25): anxiety, depression- self-rating Somatisation - 12 items from SCL-90: self-rating VAS: pain in 4 different areas of the body self-rating Hamilton depression and anxiety (HAM D+ A): observer-rating (blinded) Global Assessment of Funtioning, symptoms (GAF-S): observer-rating Level of functioning and social support Sheehan Disability Scale (SDS): work, social life & family - self-rating Global Assessment of Functioning, functioning (GAF-F): observer-rating Social Attainment Scale (SAS-SR): social functioning - self rating Crisis Support Scale (CSS): support from social network self-rating Quality of life WHO-5: self-rating

8 THE TREATMENT STRUCTURE AT CTP 8 Pre- treatment assessment Phase 1 (2 months) Social counselling 6 consultations with medical doctor 1/week: Pharmacological treatment antidepressants Supportive, ressource oriented sessions Psychoeducation Phase 2 (4 months) CBT 16 sessions, 1/week Consultations with medical doctor 1/month Evaluation After 6 and 18 months follow-up interviews

9 EXAMPLES FROM TRIM DATACOLLECTION TRAUMA HSTORY Traumatisation Living in a warzone Yes No If yes how long <1 year 1-5 years Living in refugee camp Yes Noj Hvis ja, varighed <1 month Torture Yes Tortured by Public authority <1 year No Others: 6-10 years 1-5 years >10 years >5 years When (last episode) <1 year ago 1-5 years ago 6-10 years ago >10 years ago

10 10 EXAMPLES FROM TRIM DATACOLLECTION METHODS USED Psycho-education (IRT) Session no Vicious sleep circles Functions of nightmars Victims identity Other methods Mindfulness Life line

11 FACTS ABOUT CTP PATIENTS 11 Cross cultural sample majority from Middle eastern countries All referred through a doctor most have been through at least some treament already High degree of comorbidity around 98% with depression and 96% with chronic pain Many psycho-social problems more than 90% on social welfare benefits An average of 14 years in DK at treatment start quite chronic group

12 TRAUMA HISTORY OF TYPICAL CTP STUDY SAMPLE % 53 % 94 % 25 % Torture Imprisonment War experience Refugee camp

13 RESEARCH SO FAR 13 Observational study 1: Combined bio-psycho-social treatment Cultural acceptance and implementation PTF1: 4-armed trial comparing medical-, psychological and combined treatment groups as well as a waiting list control group PTF2: 2-armed trial focusing on psychotherapy: Stress Management versus Cognitive Restructuring PTF3: 2-armed trial focusing on pharmacological treatment: Sertraline versus Venlafaxine (in combination with psychotherapy) PTF4: 3-armed trial focusing on physiotherapy: BBAT, mixed physical activity and a treatment as usual control group PTF5: 4-armed trial focusing on sleep: comparing IRT, Mianserine, a combination of the two and a treatment as usual group

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15 RESEARCH OUTCOMES 15 RCT s => World class database => reliable predictive measures => Optimise best practice treatment Contributes to: a better understanding of trauma-affected refugees and their problems a more effective and individualised treatment approach

16 TRIM: MEETING SOME OF THE CHALLENGES 16 No extra burden for research participants all patients complete the same questionnaires No placebo group - all patients receive active best practice treatment (and at the same time contribute to make a difference for future patients) Cross cultural manuals meeting the challenges of being a refugee manuals are flexible and a start off point for treatment is the individual and his/her personal story

17 SOME POINTS OF DISCUSSION 17 Can TRIM be implemented anywhere? Are some clients too vulnerable to participate in research?

18 DOES IT HURT TO ASK? 18 Jaffe et al. 2015: A meta-analysis of participants reaction to trauma research 73,959 participants across 70 samples Although trauma-related research can lead to some immediate psychological distress, this distress is not extreme [ ] Individuals generally find participation in research to be a positive experience and do not regret participation regardsless of trauma history or PTSD

19 Thank you To all of you for listening To patients and staff at CTP for making our studies possible To CTP chief consultant Morten Ekstroem and head of research Jessica Carlsson for making CTP an amazing place for both patients and staff-members WANT TO KNOW MORE? : : Ref: Carlsson, Sonne, Silove: From Pioneers to Scientists: Challenges in Establishing Evidence- Gathering Models in Torture and Trauma Mental Health Services for Refugees; J Nerv Ment Dis, 2014