Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial

Anxiety disorders are a great burden for patients, the general health system and society as a whole. Patients having an anxiety disorder suffer from considerable disability and reduced quality of life [1]. In addition, anxiety disorders are associated with significant costs due to the use of health services and reduced productivity [2].

Of the anxiety disorders, panic disorder (PD) and generalized anxiety disorder (GAD) are the most disabling [3] and costly [4‐6] anxiety disorders that are frequently seen in primary care. Research has indicated that four to seven percent of primary care attendees suffer from one or both of these anxiety disorders [7‐10].

As the majority of these patients is only seen in primary care [6, 11], this may be a convenient setting to treat these disorders. Treatment for PD and GAD can be highly effective [12, 13]. In recent decades the evidence for the effectiveness of treatments for anxiety disorders has been reviewed and described in clinical guidelines for treatment, where cognitive behavioral therapy as well as prescription of antidepressants are considered as first choice of treatment for PD and GAD [14‐16]. However, these guidelines are rarely adhered to in primary care. About one third of patients with an anxiety disorder treated in primary care receive appropriate treatment as defined by a minimal accordance with existing guidelines [6, 17, 18].

One of the reasons for the low quality of treatment is poor recognition of anxiety disorders. Even when compared to depression, the recognition rate of anxiety disorders is low, with about one third of anxiety disorder patients labeled as such by their general practitioner (GP) [19‐21]. Several factors are involved in this low recognition rate, such as patients unwillingness or inability to discuss their anxiety problems with their GP [11, 22, 23] and limited knowledge of GPs about psychiatric disorders. Moreover, GPs frequently work under time pressure and perceive they have not enough time to enquire about emotional problems. In conclusion, competing demands of the patient, the GP and the primary care structure of acute episodic care make diagnosing mental health problems difficult [24].

Although ameliorating recognition of anxiety disorders is necessary [25], it is not sufficient for improving primary health care for these patients [26‐28]. GPs often feel they do not have the necessary capabilities to treat these problems [23, 29]. Moreover, the primary care system does not seem to be well organized for care for anxiety disorders [25]. As anxiety disorders often have a chronic nature [30], they make a poor fit with the acute disease model of primary care [10]. Therefore, several researchers have proposed to use a chronic care model to implement evidence based care into practice. The most promising of these strategies are based on Wagner's model of care for chronic diseases [31]. This model was originally developed to improve treatment for chronic diseases like diabetes. The strategies following Wagner's model involve collaborative disease management with a pivotal role for a "care manager", who coordinates care, works according to an evidence-based treatment protocol, monitors treatment response and actively follows the patient. This care manager usually is a non-physician professional, who works in close collaboration with the GP. Care manager and GP are further assisted by a specialist from secondary care. This model was adopted for use with mental disorders, with a nurse practitioner or a psychologist as care manager and a psychiatrist functioning as consultant specialist [32, 33].

This collaborative care model has been tested extensively in the treatment of depression, showing robust positive results [34, 35]. A few studies in the United States have investigated the effectiveness of collaborative care for anxiety disorders, especially PD [36‐38] and GAD [37]. When compared to other strategies for improving care for anxiety disorders in ambulatory care, collaborative care seems to be the most effective [39]. In two of the studies described above a cost-effectiveness analysis was performed. In both studies, collaborative care was more effective than care as usual. Results regarding cost effectiveness were inconclusive, with collaborative care being either more or less costly than care as usual [40, 41]. Researchers of these collaborative care trials [36] and international guidelines [15] recommend a stepped care approach for mental health care in primary care, with least invasive and costly interventions preceding more invasive and expensive forms of care. Such an approach may make collaborative care interventions more cost-effective.

This article describes the aims and methods of a randomized controlled trial to test the effectiveness of a collaborative stepped care intervention for PD and GAD in primary care in the Netherlands. Such a study is warranted for two reasons. First, there has been no study on the cost-effectiveness of a collaborative care intervention for anxiety disorders that includes a stepped care approach. Second, published studies about collaborative care for anxiety disorders all stem from the United States (US), where the collaborative care model was originally developed. As there are significant differences across health care systems in the US and in European countries [42], the results of the collaborative care studies might not be generalized to other countries without consideration. To fill this gap in research, we designed a collaborative stepped care intervention for GAD and PD in the primary care setting. The treatment algorithm is built up from three interventions that have separately been proven effective and feasible in the primary care setting [29, 43]. The interventions consist of guided self help, cognitive behavioral therapy, and antidepressant medication [43]. Other elements of collaborative care include a trained care manager (a mental health practice nurse or psychologist) who coordinates care and provides psychological treatment, the availability of a consultant psychiatrist for advising GP and care manager, telephone follow-up by the care manager and monitoring of anxiety symptoms to evaluate treatment progress and outcome. Effects and costs of the interventions will be assessed and an economic evaluation will be performed to estimate cost-effectiveness and cost-utility of the intervention. All relevant costs to society associated with the burden of anxiety disorders will be taken into account. In accordance with the outcomes of similar previous studies, it is hypothesized that the collaborative stepped care intervention will be at least more effective and possibly less expensive than care as usual.

The presumed poor quality of care in the primary care setting for such prevalent, disabling and costly disorders as PD and GAD set the basis for this study. The aims of this study are to improve the quality of care for these patients with an acceptable increase in costs.

This study is the first in which a stepped care approach is incorporated in a collaborative care intervention for the treatment of anxiety disorders in primary care. It is also the first study, to our knowledge, that evaluates the cost-effectiveness of such an intervention outside the United States. Effective elements of other studies have been brought together in the protocol of this study.

A strength of this study is its pragmatic design. There is a minimum of exclusion criteria. Furthermore, care is provided by health care professionals from the field, unlike in other studies evaluating collaborative care [36‐38]. Consequently, the results of this study may be generalized to naturalistic health care settings with a comparable primary health care system and will be easy to implement into practice.