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      Trauma-affected refugees treated with basic body awareness therapy or mixed physical activity as augmentation to treatment as usual—A pragmatic randomised controlled trial

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          Abstract

          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.

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          Most cited references31

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          SCAN. Schedules for Clinical Assessment in Neuropsychiatry.

          After more than 12 years of development, the ninth edition of the Present State Examination (PSE-9) was published, together with associated instruments and computer algorithm, in 1974. The system has now been expanded, in the framework of the World Health Organization/Alcohol, Drug Abuse, and Mental Health Administration Joint Project on Standardization of Diagnosis and Classification, and is being tested with the aim of developing a comprehensive procedure for clinical examination that is also capable of generating many of the categories of the International Classification of Diseases, 10th edition, and the Diagnostic and Statistical Manual of Mental Disorders, revised third edition. The new system is known as SCAN (Schedules for Clinical Assessment in Neuropsychiatry). It includes the 10th edition of the PSE as one of its core schedules, preliminary tests of which have suggested that reliability is similar to that of PSE-9. SCAN is being field tested in 20 centers in 11 countries. A final version is expected to be available in January 1990.
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            Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases.

            This paper reports the development of a self-report instrument designed to assess pain in cancer and other diseases. It is argued that issues of reliability and validity should be considered for every pain questionnaire. Most research on measures of pain examine reliability to the relative neglect of validity concerns. The Wisconsin Brief Pain Questionnaire (BPQ) is evaluated with regard to both reliability and validity. Data from patients with cancer at 4 primary sites and from patients with rheumatoid arthritis suggest that the BPQ is sufficiently reliable and valid for research purposes. Additional methodological and theoretical issues related to validity are discussed, and the need for continuing evaluation of the BPQ and other measures of clinical pain is stressed.
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              Chronic pain and posttraumatic stress disorder: mutual maintenance?

              Common sequelae following a traumatic event include chronic pain and posttraumatic stress disorder (PTSD). Over the last decade, the literature relating to PTSD has become progressively more sophisticated, resulting in well-supported theories and treatments for sufferers. Equivalent research relating to chronic pain has more recently gathered momentum. However, to date there has been minimal attention devoted to the concurrence of the two disorders, even though high comorbidity has been noted. This review begins by briefly summarizing the literature relating to the two disorders in terms of symptoms, prevalence and comorbidity. It explicates the major psychological theories of chronic pain and PTSD and reviews the evidence relating what factors maintain the disorders. A number of pathways by which chronic pain and PTSD may be mutually maintaining are highlighted. We conclude that chronic pain and PTSD are mutually maintaining conditions and that there are several pathways by which both disorders may be involved in the escalation of symptoms and distress following trauma. Treatment implications are considered, as are issues for future research.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                12 March 2020
                2020
                : 15
                : 3
                : e0230300
                Affiliations
                [1 ] Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark
                [2 ] Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
                [3 ] Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark
                IRCCS E. Medea, ITALY
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0002-9367-6637
                http://orcid.org/0000-0002-8206-0191
                Article
                PONE-D-19-16080
                10.1371/journal.pone.0230300
                7067472
                32163509
                7745ba22-573f-4842-9d91-225e4f560e8c
                © 2020 Nordbrandt et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 18 June 2019
                : 25 February 2020
                Page count
                Figures: 1, Tables: 2, Pages: 16
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100007437, TrygFonden;
                Award ID: 102265
                Award Recipient : Jessica Carlsson Carlsson
                JC received 4 million DKK from TrygFonden for this study. Grant number: 102265 URL: https://www.trygfonden.dk/english Role of the funding source: The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Public and Occupational Health
                Physical Activity
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Mood Disorders
                Depression
                Medicine and Health Sciences
                Health Care
                Health Education and Awareness
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Medical Doctors
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Medical Doctors
                Medicine and Health Sciences
                Health Care
                Physiotherapy
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Neuropsychiatric Disorders
                Anxiety Disorders
                Post-Traumatic Stress Disorder
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Neuroses
                Anxiety Disorders
                Post-Traumatic Stress Disorder
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Psychologists
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Custom metadata
                According to Danish legislation, as long as the patient identification list (which combines the Civil Personal Registration (CPR) number with the patient-ID number) is still existing, sharing of the data (in a de-identified format) is only allowed once permission from the Danish Data Protection Agency is obtained, which requires a signed data sharing agreement. When the permission for data processing expires (by May 16, 2028), deleting the patient identification list will fully anonymise data. Hereafter all collected data including the data dictionary are planned to be transferred to the Danish National Archives ( https://www.sa.dk/en/), from where assess to the data can be granted to researchers who provide a methodologically sound proposal, and who are seeking to achieve aims described in the approved proposal. Proposals should be directed to mailbox@ 123456sa.dk Data requestors will need to sign a data sharing agreement. Additional material is available online in the form of the study protocol ( https://www.ncbi.nlm.nih.gov/pubmed/26492879), and the informed consent form www.ctp-net.dk.

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