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

Nadja Kehler Curth, Ursula Ødum Brinck-Claussen, Annette Sofie Davidsen, Marianne Engelbrecht Lau, Merete Lundsteen, John Hagel Mikkelsen, Claudio Csillag, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov, Nadja Kehler Curth, Ursula Ødum Brinck-Claussen, Annette Sofie Davidsen, Marianne Engelbrecht Lau, Merete Lundsteen, John Hagel Mikkelsen, Claudio Csillag, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov

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.

Keywords: Anxiety disorders; Cluster-randomised trial; Collaborative care; General practice; Generalised anxiety disorder; Panic disorder; Shared care; Social phobia.

Conflict of interest statement

Ethics approval and consent to participate

The trials will be conducted in compliance with this protocol, the Helsinki Declaration, Good Clinical Practice guidelines and following the rules for informed consent.

Electronically stored data will be kept in entry-restricted files and other data will be stored in sealed cupboards. Personally identifiable data will be treated according to the Danish law on the handling of personal information (in Danish ‘Lov om behandling af personoplysninger’).

The GP obtains the patients’ consent to participation, which is based on verbal information and written material. Written declarations of consent must be signed, and the participants will receive a copy. Participants will be informed of their rights to exit the study at any point and without consequences for their future treatment. If they withdraw from the study they can specify how their data are used.

The authors of this protocol are not aware of previous trials reporting any risks or adverse events of collaborative care. In order to minimise the possible risks of discomfort during interviews these will be conducted in a flexible manner with breaks if necessary. If any of the participants present acute suicidal ideation during interviews, the assessor will consult a clinician or contact the emergency services if necessary. There are currently no known circumstances that can lead to exclusion from participation once a patient is included. If such circumstances arise, the participant will be notified.

The trial protocol has been evaluated and approved by the Regional Ethics Committees of the Capital Region (identification no: H-3-2013-203). It is also approved by the Danish College of General Practitioners’ Multi Practices Committee, the Danish Data Protection Agency (journal no: 2007-58-0015, local journal no: RHP-2014-012) and has been registered at http://www.clinicaltrials.gov (identification no: NCT02678624). No substantial deviation from the protocol will be implemented without the prior review and approval of relevant authorities. Results will be published in international journals.

A Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist has been completed and is available in Additional file 1. The (SPIRIT) figure for an overview of time schedule, assessment instruments and source of data collection has been completed and is available in Fig. 2.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart for participants. Each trial has a flow chart similar to this
Fig. 2
Fig. 2
Time schedule, assessment instruments and source of data collection

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