Abstract
Background
Panic disorder (PD) is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group.
Methods/design
A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR). Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery.
Discussion
This study was designed to evaluate the (cost) effectiveness of an early intervention based on cognitive behavioural principles. The strong external validity is one of the strengths of the study design.
Trial registration
Current Controlled Trials ISRCTN33407455.
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Details
1 VU-University, Department of Clinical Psychology and EMGO Institute, Amsterdam, The Netherlands (GRID:grid.12380.38) (ISNI:0000000417549227); GGNet, Community Mental Health Center, Warnsveld, The Netherlands (GRID:grid.491146.f)
2 Trimbos instituut (Netherlands Institute of Mental Health and Addiction), Utrecht, The Netherlands (GRID:grid.416017.5) (ISNI:0000000108358259)
3 VU-University, Department of Clinical Psychology and EMGO Institute, Amsterdam, The Netherlands (GRID:grid.12380.38) (ISNI:0000000417549227); Trimbos instituut (Netherlands Institute of Mental Health and Addiction), Utrecht, The Netherlands (GRID:grid.416017.5) (ISNI:0000000108358259)
4 VU-University Medical Center, Department of Psychiatry and EMGO Institute, Amsterdam, The Netherlands (GRID:grid.16872.3a) (ISNI:000000040435165X)
5 Leiden University Medical Center, Leiden University, Unit of Clinical Psychology, Institute of Psychological Research and Department of Psychiatry, Leiden, The Netherlands (GRID:grid.16872.3a)