introduction the treatment of traumatized refugees is one of the least researched areas within the...
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Introduction
The treatment of traumatized refugees is one of the least researched areas within the field of psychiatry. This is a problem for both patients and mental health workers, who wants to offer evidence based treatment to this group of patients. More than 100.000 refugees are living in Denmark alone. Studies estimates that more than 30% of refugees suffer from Post Traumatic Stress Disorder (PTSD) making this patient group considerable in size as well as a socio-economic challenge(1). Sufficient evidence is lacking on the efficiency of medical and psychological treatments of traumatized refugees with PTSD(2). Furthermore the relationship between psychosocial resources and treatment outcome is yet to be investigated(3). The pharmacological treatments of choice is Selective Serotonin Reuptake Inhibitors (SSRI), but evidence is scarce for its effect on complex PTSD in traumatized refugees(4). Dual-action antidepressants could be a promising alternative(5)(6) but so far it has only been studied in one very small randomised trial (7)
Method
This study will include approximately 150 patients, randomized into two groups treated with either Sertraline or Venlafaxine. Patients in both groups will receive the same manual-based Cognitive Behavioural Therapy adapted to this group of patients. The study period is 6-7 months. Treatment course and data collection is shown in the figure below and consist of: • 10 consultations with a medical doctor• 16 consultations with a psychologist• At least 2 individual sessions with social counselors and option to participate in group lectures.
The treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapyCharlotte Sonne1,2, Jessica Carlsson1, Morten Ekstrøm1, Ask Elklit2, , Per Bech3 and Erik Lykke Mortensen3
1Competence Center for Transcultural Psychiatry (CTP), Psychiatric Center Ballerup, Mental Health Services - Capital Region of Denmark.2University of Southern Denmark 3University of Copenhagen
Social counselors are conducting group lectures on the Danish social service system and other topics relevant to the patients
REFERENCES:
1. Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M: Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA 2009;302(5):537-49.
2. Hetrick S, Purcell R, Garner B, Parslow R: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder ( PTSD ). The Cochrane Library 2010.
3. Region Syddanmarks Center for Kvalitet: MTV om behandling og rehabilitering af PTSD – herunder traumatiserede flygtninge. 2008. http://doc.rct.dk/
4. Stein DJ, Ipser J, Seedat S: Pharmacotherapy for post traumatic stress disorder ( PTSD ). The Cochrane Library 2009.
5. Davidson J, Rothbaum BO, Tucker P, Asnis G, Benattia I, Musgnung JJ: Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo-controlled study. J Clin Psychopharmacol. 2006 Jun;26(3):259-67
6. Hamner MB, Frueh BC: Response to Venlafaxine in a previously antidepressant treatment-resistant combat veteran with post-traumatic stress disorder. Int Clin Psychopharmacol.1998 Sep;13(5):233–4.
7. Smajkic A, Weine S, Djuric-Bijedic Z, Boskailo E,Lewis J, Pavkovic I: Sertraline, Paroxetine, and Venlafaxine in Refugee Posttraumatic Stress Disorder With Depression symptoms. J Trauma Stress. 2001 Jul;14(3):445-52.
Pre-treatment consultation (project
information and inclusion)
Pre-treatment consultation (project
information and inclusion)
Pre-treatment consultation:
1st self-rating 1st HAM D + A observer rating
Pre-treatment consultation:
1st self-rating 1st HAM D + A observer rating
Weekly consultations with medical doctor: treatment with Sertraline + psycho-education.
Weekly consultations with medical doctor: treatment with Sertraline + psycho-education.
Weekly consultations with medical doctor: treatment with Venlafaxine + psycho-education.
Weekly consultations with medical doctor: treatment with Venlafaxine + psycho-education.
Weekly psychotherapy sessions with psychologist.Monthly consultations with medical doctor; adjustment of Sertraline dosage and psycho-education.
Weekly psychotherapy sessions with psychologist.Monthly consultations with medical doctor; adjustment of Sertraline dosage and psycho-education.
Weekly psychotherapy sessions with psychologist.Monthly consultations with medical doctor; adjustment of Venlafaxine dosage and psycho-education.
Weekly psychotherapy sessions with psychologist.Monthly consultations with medical doctor; adjustment of Venlafaxine dosage and psycho-education.
After 6-7 months’ treatment programme: Evaluation and
termination of treatment programme
After 6-7 months’ treatment programme: Evaluation and
termination of treatment programme
Week 1-6of treatment
Week 6-24 of treatment
After 6 weeks of treatment:
2nd self-rating
After 6 weeks of treatment:
2nd self-rating
After completion of treatment:
3rd self-rating 2nd HAM D + A
observer rating
After completion of treatment:
3rd self-rating 2nd HAM D + A
observer rating
Evidence of the efficacy of medical and psychological treatments of traumatized refugees with PTSD is very scarce.
In the present study two types of antidepressants and 15 possible outcome predictors are investigated. The aim is to generate new knowledge on treatment and clinical evaluation of traumatized refugees which can be used in reference programmes and clinical guidelines.
Results are expected to be published ultimo 2014.
Evidence of the efficacy of medical and psychological treatments of traumatized refugees with PTSD is very scarce.
In the present study two types of antidepressants and 15 possible outcome predictors are investigated. The aim is to generate new knowledge on treatment and clinical evaluation of traumatized refugees which can be used in reference programmes and clinical guidelines.
Results are expected to be published ultimo 2014.
Take home messages
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Study supported by:
Helsefonden
To examine differences in the treatment outcome of patients treated with Venlafaxine and Sertraline respectively.
To study the relation between changes in symptoms on PTSD /depression and changes in social functioning from baseline to post-treatment evaluation.
To investigate if pre-treatment ratings of patients’ psycho-social resources correlate with the treatment outcome of the individual patient.
To examine differences in the treatment outcome of patients treated with Venlafaxine and Sertraline respectively.
To study the relation between changes in symptoms on PTSD /depression and changes in social functioning from baseline to post-treatment evaluation.
To investigate if pre-treatment ratings of patients’ psycho-social resources correlate with the treatment outcome of the individual patient.
Objectives
Outcome measures
Trial endpoints will be PTSD, depressive and anxiety symptoms as well as social functioning measured by validated ratings scales – see figure 1. Furthermore,15 different psycho-social factors that might be associated with treatment outcome, are rated on a 0-4 Likert scale during the first session with the patient. At the end of the treatment course, the individual predictors as well as the total score from the Likert scale is compared with changes on the primary outcome measures.
Figure 1: Primary and secondary outcome measures
Primary outcome measure Harvard Trauma Questionnaire (HTQ) part IV: Self-rating consisting of 16 items. Used to monitor the severity of PTSD symptoms
Secondary outcome measures Hopkins Symptom Check List-25 (HSCL-25): Self-raring consisting of 25 items. Used to monitor the severity of anxiety and depressive symptoms.
Social Adjustment Scale Self Report (SAS-SR) short version: Self-raring consisting of 24 items. Used to monitor changes in social functioning.
Hamilton Depression and Anxiety Ratings Scales (HAM D+A ): Semi-structured interviews used to monitor depressive and anxiety symptoms. In this study the interviews are carried out by a trained team of medical students who are blinded towards the intervention groups
AUTHOR FOR CORRESPONDANCE:
Charlotte Sonne, MD, PhD-studentCompetence Center for Transcultural PsychiatryGentofte HospitalNiels Andersensvej 65Tel. +45 3864 6173E-mail: [email protected]