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      Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials

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          Abstract

          Background

          People with anxiety disorders represent a significant part of a general practitioner’s patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations.

          A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders.

          Methods

          Three cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months.

          Discussion

          Results will add to the limited pool of information about collaborative care for patients with anxiety disorders. To our knowledge, these will be the first carried out in a Danish context and the first to report results for generalised anxiety and social phobia separately. If the trials show positive results, they could contribute to the improvement of future treatment of anxiety disorders.

          Trial registration

          ClinicalTrials.gov, ID: NCT02678624. Retrospectively registered 7 February 2016; last updated 15 August 2016,

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-017-2120-3) contains supplementary material, which is available to authorized users.

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          Most cited references37

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          The global burden of mental disorders: An update from the WHO World Mental Health (WMH) Surveys

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            Current and lifetime comorbidity of the DSM-IV anxiety and mood disorders in a large clinical sample.

            The comorbidity of current and lifetime DSM-IV anxiety and mood disorders was examined in 1,127 outpatients who were assessed with the Anxiety Disorders Interview Schedule for DSM-IV: Lifetime version (ADIS-IV-L). The current and lifetime prevalence of additional Axis I disorders in principal anxiety and mood disorders was found to be 57% and 81%, respectively. The principal diagnostic categories associated with the highest comorbidity rates were mood disorders, posttraumatic stress disorder (PTSD), and generalized anxiety disorder (GAD). A high rate of lifetime comorbidity was found between the anxiety and mood disorders; the lifetime association with mood disorders was particularly strong for PTSD, GAD, obsessive-compulsive disorder, and social phobia. The findings are discussed in regard to their implications for the classification of emotional disorders.
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              Assessment of client/patient satisfaction: development of a general scale.

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                Author and article information

                Contributors
                nadja.kehler.curth.01@regionh.dk
                ursula.brinck-claussen@regionh.dk
                adavid@sund.ku.dk
                marianne.engelbrecht.lau@regionh.dk
                mlu@dadlnet.dk
                john.hagel.mikkelsen@regionh.dk
                claudio.csillag@regionh.dk
                carsten.hjorthoej@regionh.dk
                merete.nordentoft@regionh.dk
                lene.falgaard.eplov@regionh.dk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                16 August 2017
                16 August 2017
                2017
                : 18
                : 382
                Affiliations
                [1 ]ISNI 0000 0004 0631 4836, GRID grid.466916.a, Mental Health Center Copenhagen, , Mental Health Services, Capital Region of Denmark, ; Kildegårdsvej 28, 2900 Hellerup, Denmark
                [2 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Research Unit for General Practice and Section of General Practice, , University of Copenhagen, ; Øster Farimagsgade 5, PO Box 2099, 1014 Copenhagen K, Denmark
                [3 ]ISNI 0000 0004 0631 4836, GRID grid.466916.a, Stolpegård Psychotherapy Centre, , Mental Health Services, Capital Region of Denmark, ; Stolpegårdsvej 20, 2820 Gentofte, Denmark
                [4 ]ISNI 0000 0004 0631 4836, GRID grid.466916.a, Mental Health Center Frederiksberg, , Mental Health Services, Capital Region of Denmark, ; Nordre Fasanvej 57-59, 2000 Frederiksberg, Denmark
                [5 ]ISNI 0000 0004 0631 4836, GRID grid.466916.a, Mental Health Center North Zealand, , Mental Health Services, Capital Region of Denmark, ; Dyrehavevej 48, 3400 Hillerød, Denmark
                [6 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Institute for Clinical Medicine, , University of Copenhagen, Mental Health Center Copenhagen, Mental Health Services, Capital Region of Denmark, ; Kildegårdsvej 28, 2900 Hellerup, Denmark
                [7 ]Independent General Practitioner, Copenhagen, Denmark
                Article
                2120
                10.1186/s13063-017-2120-3
                5559780
                28814317
                4df4d88a-c8ba-48f6-928f-cc001a52174e
                © The Author(s). 2017

                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
                : 26 December 2016
                : 26 July 2017
                Funding
                Funded by: Danish Ministry of Health
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2017

                Medicine
                collaborative care,shared care,anxiety disorders,panic disorder,generalised anxiety disorder,social phobia,cluster-randomised trial,general practice

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