Abstract
BackgroundPanic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness.Methods/DesignThis is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs.Trial registrationCurrent Controlled Trials [http://ISCRTN64669297]
Highlights
Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders
Compared to individuals without anxiety disorders, patients suffering from panic disorder with or without agoraphobia (PD/AG) show increased health service use and more than three times as many work loss days [5,6]
The findings indicate that teaching coping skills, or using cognitive restructuring, do not increase clinical outcomes above exposure exercises alone [41]
Summary
Based on European epidemiological studies, the 12month prevalence of panic disorder (PD) is estimated at 1.8% [1]. Primary care therapists can deliver key-elements of CBT to patients with PD/AG as a first step in treatment [25,26] These keyelements include psychoeducation (offering evidencebased information about disorder and treatment options), bibliotherapy (for example, written self-help books), and motivating patients for self-managed exposure techniques by discussion and instruction. Improving treatment for panic disorder and agoraphobia in primary care by means of a practice team-supported exposure programme Collaborative chronic care models (CCM) provide an evidence-based framework for improving quality of care for patients with chronic illnesses in outpatient settings [42,43,44]. Aims and objectives Clinical effectiveness of primary health care for patients with PD/AG can potentially be improved by guiding patients to CBT-oriented exposure exercises within the framework of practice team-based case management. Secondary objectives are to determine if the programme is superior to usual care regarding further clinical parameters, patients’ perspectives on receipt of care, and direct and indirect health-economic costs from a societal perspective
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