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Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: Study protocol of a randomised controlled trial.

ABSTRACT: Treatment of traumatised refugees is one of the fields within psychiatry, which has received little scientific attention. Evidence based treatment and knowledge on the efficiency of the treatment for this complex patient group is therefore scarce. This leads to uncertainty as to which treatment should be offered and potentially lowers the quality of life for the patients. Chronic pain is very common among traumatised refugees and it is believed to maintain the mental symptoms of trauma. Hence, treating chronic pain is believed to be of high clinical value for this patient group. In clinical studies, physical activity has shown a positive effect on psychiatric illnesses such as depression and anxiety and for patients with chronic pain. However, scientific knowledge about physical activity as part of the treatment for traumatised refugees is very limited and no guidelines exist on this topic.This study will include approximately 310 patients, randomised into three groups. All three groups receive psychiatric treatment as usual for the duration of 6-7 months, consisting of consultations with a medical doctor including pharmacological treatment and manual-based Cognitive Behavioural Therapy. The first group only receives treatment as usual while the second and the third groups receive either Basic-Body Awareness Therapy or mixed physical activity as add-on treatments. Each physical activity is provided for an individual 1-hour consultation per week, for the duration of 20 weeks. The study is being conducted at the Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup in the Capital Region of Denmark. The primary endpoint of the study is symptoms of Post Traumatic Stress Disorder; the secondary endpoints are depression and anxiety as well as quality of life, functional capacity, coping with pain, body awareness and physical fitness.This study will examine the effect of physical activity for traumatised refugees. This has not yet been done in a randomised controlled setting on such a large scale before. Hereby the study will contribute to important knowledge that is expected to be used in future clinical guidelines and reference programs.ClinicalTrials.gov NCT01955538 . Date of registration: 18 September 2013.

SUBMITTER: Nordbrandt MS

PROVIDER: S-EPMC4619210 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: Study protocol of a randomised controlled trial.

Nordbrandt Maja Sticker MS Carlsson Jessica J Lindberg Laura Glahder LG Sandahl Hinuga H Mortensen Erik Lykke EL

Trials 20151022

<h4>Background</h4>Treatment of traumatised refugees is one of the fields within psychiatry, which has received little scientific attention. Evidence based treatment and knowledge on the efficiency of the treatment for this complex patient group is therefore scarce. This leads to uncertainty as to which treatment should be offered and potentially lowers the quality of life for the patients. Chronic pain is very common among traumatised refugees and it is believed to maintain the mental symptoms ...[more]

PMID: 26492879

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Project description: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 comorbid conditions best in trauma-affected refugees. AIM:The aim of the present study was to investigate if adding either BBAT or mixed physical activity to the treatment as usual (TAU) for trauma-affected refugees with PTSD would increase the treatment effect compared to TAU alone. METHOD:Randomised controlled trial, 3-armed parallel group superiority study, conducted at Competence Centre for Transcultural Psychiatry, Denmark. Participants were adult trauma-affected refugees with PTSD. Allocation ratio was 1:1:1, stratified for PTSD severity and gender. An open-label design was applied due to the nature of the intervention. Participants were randomised to receive either individual basic body awareness therapy (group B) or individual mixed physical activity (group M) one hour/week for 20 weeks plus TAU, or TAU only (group C). The primary outcome was PTSD severity measured by Harvard Trauma Questionnaire (HTQ). Trial registration: ClinicalTrials.gov, NCT01955538. RESULTS:Of the 338 patients included (C/B/M = 110/114/114), 318 patients were eligible for intention-to-treat analysis (C/B/M = 104/105/109). 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. CONCLUSIONS: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. There is a need for studies on potential subpopulations of trauma-affected refugees who could benefit from physical activity as a part of their treatment.

Project description:Introduction No evaluated therapeutic approaches, that can efficiently be established in routine mental healthcare, are currently available for traumatised adolescent refugees in Germany. This study evaluates the efficacy of the Stress-Traumasymptoms-Arousal-Regulation-Treatment (START) programme to reduce trauma-related symptoms and psychological distress in traumatised adolescent refugees based in Germany. Methods and analysis This randomised, waiting-list-controlled, multicentre trial with a 12-week follow-up will include 174 refugee minors with partial or full post-traumatic stress disorder who are fluent in either Arabic, Dari, English, German or Somali. Eligible refugee minors will be randomised to the START or waiting-list control groups. The manualised 8-week START programme is based on techniques of dialectical behaviour therapy (DBT), fosters adaptive coping with emotional distress and traumatic symptoms and comprises eight therapy modules and a booster session. Study assessments are planned at baseline, post-treatment (ie, after programme participation or waiting time), booster session at week 12 or 12-week waiting time, and at the 12-week follow-up. Primary and coprimary outcomes are changes in psychological distress and traumatic symptoms at post-treatment and will be analysed as response variables in linear mixed regression models. Secondary outcomes are changes in further trauma-related and other psychopathological symptoms, emotion regulation and intermediate effects of the programme at follow-up. We will also assess effects of the programme with ecological momentary assessments and on neuroendocrine stress parameters using hair cortisol. Ethics and dissemination This study has been approved by the lead ethics committee of Rhineland-Palatinate and the ethics committees of participating sites. The study results will be disseminated through peer-reviewed publications and scientific conferences. Trial registration number DRKS00020771.

Project description:BackgroundPsychological distress due to the ongoing war, violence, and persecution is particularly common among Afghan asylum seekers and refugees. In addition, individuals face a variety of post-migration living difficulties (PMLDs). Complex posttraumatic stress symptoms are among the most common mental health problems in this population, and were associated with the overall burden of PMLDs. The complex interplay of posttraumatic symptoms has been investigated from a network perspective in previous studies. However, individuals are embedded in and constantly react to the environment, which makes it important to include external factors in network models to better understand the etiology and maintaining factors of posttraumatic mental health problems. PMLDs are a major risk factor for posttraumatic distress and considering their impact in interventions might improve response rates. However, the interaction of these external factors with posttraumatic psychopathological distress is not yet fully understood. Thus, we aimed to illuminate the complex interaction between PMLDs and CPTSD symptom clusters.ObjectiveThe main objective is the exploration of the network structure and the complex interplay of ICD-11 CPTSD symptom clusters and distinct forms of PMLDs.MethodThe symptom clusters of CPTSD and PMLDs were collected within a randomised controlled trial among 93 treatment-seeking Afghan asylum seekers and refugees via a fully structured face-to-face and interpreter assisted interview. Using a network analytical approach, we explored the complex associations and network centrality of the CPTSD symptom clusters and the PMLD factors: discrimination & socio-economical living conditions, language acquisition & barriers, family concerns, and residence insecurity.ResultsThe results suggest direct links within and between the constructs (CPTSD, PMLD). Almost all PMLD factors were interrelated and associated to CPTSD, family concerns was the only isolated variable. The CPTSD symptom cluster re-experiencing and the PMLD factor language acquisition & barriers connected the two constructs. Affective dysregulation had the highest and avoidance the lowest centrality.ConclusionsRe-experiencing and affective dysregulation have the strongest ties to PMLDs. Thus, these domains might explain the strong association of posttraumatic psychopathology with PLMDs and, consequently, prioritization of these domains in treatment approaches might both facilitate treatment response and reduce burden caused by PMLDs.

Project description:BACKGROUND:Sleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD). Untreated sleep disturbances can contribute to the maintenance and exacerbation of PTSD symptoms, which may diminish treatment response and constitute a risk factor for poor treatment outcome. Controlled trials on treatment of sleep disturbances in refugees suffering from PTSD are scarce. The present study aims to examine sleep-enhancing treatment in refugees with PTSD. We aim to assess if add-on treatment with mianserin and/or Imagery Rehearsal Therapy (IRT) to treatment as usual (TAU) for PTSD improves sleep disturbances. We will study the relation between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life. METHODS:The study is a randomised controlled superiority trial with a 2?×?2 factorial design. The study will include 230 trauma-affected refugees. The patients are randomised into four groups. All four groups receive TAU - an interdisciplinary treatment approach covering a period of 6-8 months with pharmacological treatment, physiotherapy, psychoeducation and manual-based cognitive behavioural therapy within a framework of weekly sessions with a physician, physiotherapist or psychologist. One group receives solely TAU, serving as a control group, while the three remaining groups are active-treatment groups receiving add-on treatment with either mianserin, IRT or a combination of both. Treatment outcome is evaluated using self-administered rating scales, observer ratings and actigraph measurements at baseline, during treatment and post treatment. The primary outcome is subjective sleep quality using the Pittsburgh Sleep Quality Index. Secondary outcome measures are objective sleep length, nightmares, PTSD severity, symptoms of depression and anxiety, pain, quality of life and psychosocial functioning. DISCUSSION:This trial will be the first randomised controlled trial to examine sleep-enhancing treatment in trauma-affected refugees, as well as the first trial to investigate the effect of IRT and mianserin in this population. Therefore, this trial may optimise treatment recommendations for sleep disturbances in trauma-affected refugees. Based on our findings, we expect to discuss the effect of treatment, focussing on sleep disturbances. Furthermore, the results will provide new information regarding the association between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life in trauma-affected refugees. TRIAL REGISTRATION:EudraCT registration under the name 'Treatment of sleep disturbances in trauma-affected refugees - a randomised controlled trial', registration number: 2015-004153-40 , registered on 13 November 2015. ClinicalTrials.gov, ID: NCT02761161. Registered on 27 April 2016.

Project description:The prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees.The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard Trauma Questionnaire - part IV, which was the primary outcome measure. Other outcome measures included: Hopkins Symptom Check List-25 (depression and anxiety), Social Adjustment Scale - short version (social functioning), WHO-5 Well-being Index (quality of life), Crisis Support Scale (support from social network), Sheehan Disability Scale (disability in three areas of functioning), Hamilton Depression and Anxiety scale, the somatisation items of the Symptoms Checklist-90, Global Assessment of Functioning scales and the summarised score of pain in four body areas rated on visual analogue scales.Two hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma Questionnaire and a number of other ratings in both groups. On the primary outcome measure, no difference was found in treatment effect between the sertraline and venlafaxine group. A significant group difference was found in favour of sertraline on the Sheehan Disability Scale.Sertraline had a slightly better outcome than venlafaxine on some of the secondary outcome measures, but not on the primary outcome measure. Furthermore, a higher percentage of dropouts was found in the venlafaxine group compared to the sertraline group. Although this could indicate that sertraline was better tolerated, which is supported by other studies, a final conclusion on tolerability cannot be drawn from the current study due to lack of systematic reporting of side effects.ClinicalTrials.gov NCT01569685 . Registration date: 28/2/12.

Project description:BackgroundGlobally, there is an excess of 68.5 million people who have been forced to leave their homes and seek sanctuary elsewhere because of poverty, persecution, conflict, violence, and human rights violations. Although international humanitarian responses usually focus on ensuring that the basic needs of these people are being met, there is growing attention on the role that development-oriented interventions can play in the longer term. Higher education in a refugee context is one such intervention that can equip refugees with the knowledge and skills they need to serve their communities and move forward.ObjectiveThis study aims to evaluate the outcomes and effectiveness of the University of Geneva InZone-Raft Basic Medical Training Course in the Kakuma refugee camp in Kenya compared with a previous incarnation of the same course in the Dadaab refugee camp in Kenya.MethodsWe used a quasi-experimental design to compare the posttest scores of both inequivalent student groups: control group (n=18) and intervention group (n=16). Factors that influenced refugee students' knowledge acquisition, the amount of knowledge they acquired, and their academic outcomes were assessed, and the pedagogical evolution of the project is presented.ResultsWe found that the Kakuma intervention course yielded better outcomes and was more effective in terms of learning than the Dadaab control course. Of the 16 students who took part in the intervention course, 10 (63%) completed the program successfully and received accreditation from the University of Geneva. We observed that they received new knowledge well and scored higher on all learning modalities than those in the control course. Comparison of written and oral examinations between the courses showed statistical significance for the intervention group in written and oral exams (two-tailed: P=.006 and P=.05; one-tailed: P=.003 and P=.03, respectively). The Kakuma course was not effective in addressing electricity and internet access problems, nor in reducing the challenge of tight deadlines in the syllabus. Pedagogical adjustments to the intervention course improved student involvement, with higher participation rates in quizzes (10/11, 91%), and overall satisfaction and learning.ConclusionsThe intervention group-with an improved mode of delivery, better contextualized content, and further interaction-reached a higher level of medical knowledge acquisition and developed more complex questions on medical topics than the control group. The positive outcome of this project shows that given the right resources and support, refugees can contribute to the improvement and development of health care in their communities. Nonetheless, a more focused effort is necessary to meet the educational needs of refugee learners and better understand their living conditions.

Project description:IntroductionPost-traumatic symptoms are common among patients discharged from intensive care units (ICUs), adversely affecting well-being, increasing healthcare utilisation and delaying return to work. Non-pharmacological approaches (eg, music, therapeutic touch and patient diaries) have been suggested as candidate interventions and trauma-focused psychological interventions have been endorsed by international bodies. Neither category of intervention is supported by definitive evidence of long-term clinical effectiveness in patients who have been critically ill. This study assesses the feasibility and acceptability of using eye-movement desensitisation and reprocessing (EMDR) to improve the mental health of ICU survivors.Methods and analysisEMERALD is a multicentre, two-part consent, pilot feasibility study, recruiting discharged ICU survivors from three hospitals in the UK. We are gathering demographics and measuring post-traumatic symptoms, anxiety, depression and quality of life at baseline. Two months after discharge, participants are screened for symptoms of post-traumatic stress disorder (PTSD) using the Impact of Events Scale-Revised (IES-R). Patients with IES-R scores<22 continue in an observation arm for 12 month follow-up. IES-R scores≥22 indicate above-threshold PTSD symptoms and trigger invitation to consent for part B: a randomised controlled trial (RCT) of EMDR versus usual care, with 1:1 randomisation. The study assesses feasibility (recruitment, retention and intervention fidelity) and acceptability (through semistructured interviews), using a theoretical acceptability framework. Clinical outcomes (PTSD, anxiety, depression and quality of life) are collected at baseline, 2 and 12 months, informing power calculations for a definitive RCT, with quantitative and qualitative data convergence guiding RCT refinements.Ethics and disseminationThis study has undergone external expert peer review and is funded by the National Institute for Health and Care Research (grant number: NIHR302160). Ethical approval has been granted by South Central-Hampshire A Research Ethics Committee (IRAS number: 317291). Results will be disseminated through the lay media, social media, peer-reviewed publication and conference presentation.Trial registration numberNCT05591625.

Project description:Body Dysmorphic Disorder (BDD) is defined as a constant obsession with one's external appearance and flaws, and it falls under the criteria of neuropsychiatric disorders. Individuals suffering from this disorder may seek unnecessary cosmetic procedures from cosmetic treatment providers such as dermatologists or plastic surgeons. Cosmetic treatments have become readily available, which has led to an influx of undiagnosed BDD patients electing to undergo such treatments. Therefore, physicians should have the clinical knowledge about BDD to diagnose and manage these cases to avoid psychological and physical harm to these patients. However, there were no studies conducted in our region to assess the awareness of BDD among physicians who provide cosmetic treatments with regards to their attitude toward such cases and how they would manage it. This study aims to assess the awareness of Body Dysmorphic Disorder among Saudi physicians who provide cosmetic treatments. We conducted an observational cross-sectional study among physicians practicing in hospitals and cosmetic clinics in Riyadh and Jeddah city (Saudi Arabia), who perform cosmetic procedures, namely dermatologists, plastic surgeons, and otorhinolaryngologists. A paper-based questionnaire consisting of multiple-choice questions was distributed among them. The total number of participants was 155 physicians: 113 (72.9%) males and 42 (27.1%) females. Eighty-two (52.9%) participants reported that they have been familiar with the diagnostic criteria of BDD for a long time and ninety-nine (63.8%) reported being familiar with the clinical picture of BDD. Sixty-three (40.6%) participants estimated the prevalence of BDD cases seen in cosmetic practice to range from 1%-5%, and most agreed on an equal prevalence of BDD among female and male patients. Half of the participants (n = 76) (49%) reported that they sometimes share knowledge about BDD with patients whom they suspect to suffer from this condition. In conclusion, cosmetic treatment providers in Saudi Arabia are aware of BDD, but we have identified a discrepancy between the self-reported participant knowledge of diagnostic criteria and their ability to accurately estimate the prevalence of BDD cases seen in clinical practice.

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Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: Study protocol of a randomised controlled trial.

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Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: Study protocol of a randomised controlled trial.

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