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      Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial

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          Abstract

          Background

          Meta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy.

          Methods

          A randomized controlled study with a non-inferiority design is carried out in three locations of a regional outpatient psychiatric clinic for refugees. Seventy Arabic-, English- or Danish-speaking adult refugees (aged 18–67 years) diagnosed with PTSD are randomized to 16 sessions of either music therapy or verbal therapy (standard treatment). All participants are offered medical treatment, psychoeducation by nurses, physiotherapy or body therapy and social counseling as needed. Outcome measures are performed at baseline, post therapy and at 6 months’ follow-up. A blind assessor measures outcomes post treatment and at follow-up. Questionnaires measuring trauma symptoms (HTQ), quality of life (WHO-5), dissociative symptoms (SDQ-20, DSS-20) and adult attachment (RAAS) are applied, as well as physiological measures (salivary oxytocin, beta-endorphin and substance P) and participant evaluation of each session.

          Discussion

          The effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown to be impaired in traumatized refugees. The inclusion of music and imagery in the treatment of traumatized refugees hopefully will inform the choice of treatment method and expand the possibilities for improving refugee health and integration.

          Trial registration

          ClinicalTrials.gov ID number NCT03574228, registered retrospectively on 28 June 2016.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2662-z) contains supplementary material, which is available to authorized users.

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          Most cited references50

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          Brain correlates of music-evoked emotions.

          Music is a universal feature of human societies, partly owing to its power to evoke strong emotions and influence moods. During the past decade, the investigation of the neural correlates of music-evoked emotions has been invaluable for the understanding of human emotion. Functional neuroimaging studies on music and emotion show that music can modulate activity in brain structures that are known to be crucially involved in emotion, such as the amygdala, nucleus accumbens, hypothalamus, hippocampus, insula, cingulate cortex and orbitofrontal cortex. The potential of music to modulate activity in these structures has important implications for the use of music in the treatment of psychiatric and neurological disorders.
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            Working models of attachment: implications for explanation, emotion and behavior.

            Two studies examined attachment style differences in social perception. In Study 1, participants wrote open-ended explanations for hypothetical relationship events and described how they would feel and behave in response to each event. Compared with secure participants, preoccupied participants explained events in more negative ways; they also reported more emotional distress and behaviors that were likely to lead to conflict. Avoidant participants also provided negative explanations, but did not report emotional distress. Path analysis indicated that attachment style differences in behavior were mediated by explanation patterns and emotional distress. Study 2 was designed to replicate Study 1 and test the relative importance of attachment style and relationship quality to predicting each outcome. Results indicated that both variables were significant predictors of explanations, but only attachment style predicted emotional responses. These findings are consistent with the idea that adults with different working models of attachment are predisposed to think, feel, and behave differently in their relationships.
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              Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five well-being scale

              The health status questionnaire Short‐Form 36 (SF‐36) includes subscales measuring both physical health and mental health. Psychometrically, the mental health subscale contains a mixture of mental symptoms and psychological well‐being items, among other things, to prevent a ceiling effect when used in general population studies. Three of the mental health well‐being items are also included in the WHO‐Five well‐being scale. In a Danish general population study, the mental health subscale was compared psychometrically with the WHO‐Five in order to evaluate the ceiling effect. Tests for unidimensionality were used in the psychometric analyses, and the sensitivity of the scales in differentiating between changes in self‐reported health over the past year has been tested. The results of the study on 9,542 respondents showed that, although the WHO‐Five and the mental health subscale were found to be unidimensional, the WHO‐Five had a significantly lower ceiling effect than the mental health subscale. The analysis identified the three depression symptoms in the mental health subscale as responsible for the ceiling effect. The WHO‐Five was also found to be significantly superior to the mental health subscale in terms of its sensitivity in differentiating between those persons whose health had deteriorated over the past year and those whose health had not. In conclusion, the WHO‐Five, which measures psychological well‐being, reflects aspects other than just the absence of depressive symptoms. Copyright © 2003 Whurr Publishers Ltd.
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                Author and article information

                Contributors
                bolette@hum.aau.dk
                smey@regionsjaelland.dk
                us@regionsjaelland.dk
                es@regionsjelland.dk
                tcte@regionsjaelland.dk
                tooc@regionsjaelland.dk
                guhl@regionsjaelland.dk
                tormo@regionsjaelland.dk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                30 May 2018
                30 May 2018
                2018
                : 19
                : 301
                Affiliations
                [1 ]ISNI 0000 0001 0742 471X, GRID grid.5117.2, Department of Communication and Psychology, , Aalborg University, ; Aalborg, Denmark
                [2 ]Clinic for Traumatized Refugees, Køge, Region Zealand Denmark
                [3 ]Department of Specialized Functions, Psychiatry, Køge, Region Zealand Denmark
                [4 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Institute for Clinical Medicine, SUND, , Copenhagen University, ; København, Denmark
                [5 ]Research Unit in Psychiatry, Slagelse, Region Zealand Denmark
                [6 ]PFI (Production, Research, Innovation), Sorø, Region Zealand Denmark
                Article
                2662
                10.1186/s13063-018-2662-z
                5977477
                29848343
                6ba545d0-5f23-4137-9414-a5c0ba31c719
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 17 January 2018
                : 3 May 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007290, Det Obelske Familiefond;
                Award ID: 27688
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                music and imagery,refugees,randomized clinical trial,ptsd,trauma,music therapy,non-inferiority,oxytocin

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