Background: We evaluated a team-based program of exercises for patients with panic disorder with or without agoraphobia (PDA) in primary care. Methods: 419 patients with PDA (mean age 46.2 years, standard deviation 14.4 years; 74% female) were included in this cluster-randomized, controlled intervention trial. The patients were blinded with respect to their group assignment at baseline. Patients in the intervention group (36 primary-care practices, 230 patients) underwent a 23-week exercise program combined with case management, while patients in the control group (37 practices, 189 patients) received standard care. Symptoms of anxiety (according to the Beck Anxiety Inventory, BAI) at six months were the primary endpoint. Patients were followed up at six months (n = 338, 81%) and at twelve months (n = 318, 76%). The analysis was by intention to treat. Results: Symptoms of anxiety improved to a significantly greater extent in the intervention group (p = 0.008). The intergroup difference in the reduction of the BAI score (range: 0-63) was 3.0 points (95% confidence interval [−5.8; −0.2]) at six months and 4.0 points [−6.9; −1.2] at twelve months. In the intervention group, there was a significantly greater reduction in the frequency of panic attacks (p = 0.019), in avoidant behavior (p = 0.016), and in depressiveness (p<0.001), as well as a greater improvement of the quality of treatment (p<0.001). Conclusion: In primary-care patients who have panic disorder with or without agoraphobia, a team-based exercise program combined with case management can improve symptoms to a greater extent than standard primary-care treatment.
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]
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