Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

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

Preventing panic disorder: cost-effectiveness analysis alongside a pragmatic randomised trial

Abstract Background Panic disorder affects many people, is associated with a formidable disease burden, and imposes costs on society. The annual influx of new cases of panic disorder is substantial. From the public health perspective it may therefore be a sound policy to reduce the influx of new cases, to maintain the quality of life in many people, and to avoid the economic costs associated with the full-blown disorder. For this purpose, prevention is needed. Here we present the first economic evaluation of such an intervention. Methods Randomised trial of 117 people with panic disorder symptoms not meeting the diagnostic criteria of DSM-IV panic disorder. The interventions were time-limited cognitive-behavioural therapy v care-as-usual. The central clinical endpoint was DSM-IV panic disorder-free survival over 3 months. Costs were calculated from the societal perspective. Using the bootstrap method, incremental cost-effectiveness ratios were obtained, placed in 95% confidence intervals, projected on the cost-effectiveness plane, and presented as acceptability curves. Results The median incremental cost-effectiveness ratio is €6,198 (95% CI 2,435 – 60,731) per PD-free survival gained, which has a likelihood of 75.2% of being more acceptable from a cost-effectiveness point of view than care-as-usual when a willingness-to-pay ceiling is assumed of €10,000 per PD-free survival. The most significant cost driver was therapists' time. A sensitivity analysis indicated that cost-effectiveness improves when the number of therapist hours is reduced. Conclusion This is the first economic evaluation alongside a prevention trial in panic disorder. The small sample (n = 117) and the short time horizon of 3 months preclude firm conclusions, but our findings suggest that the intervention may be acceptable from a cost-effectiveness point of view, especially when therapist involvement can be kept minimal. Nevertheless, our results must await replication in a larger trial with longer follow-up times before we can confidently recommend implementation of the intervention on a broad scale. In the light of our findings and given the burden of panic disorder, such a new trial is well worth the effort

Effects and feasibility of a preventive intervention in sub-threshold and mild panic disorder: Results of a pilot study

Background Panic disorder (PD) is a serious DSM-IV axis I disorder affecting up to 3% of the adult population each year. It is associated with a large burden of disease and extensive economic costs. This study aims to examine the effects and feasibility of the 'Don't Panic' course, a preventive cognitive behavioural intervention in sub-threshold and mild PD. It also compares the effectiveness of two modifications of the course (8 vs. 12 sessions). Methods The method used was a quasi-experimental two-group pre-post design with a baseline measurement (T0) and two follow-up measurements. Follow-ups were at the end of the intervention (T1) and six months later (T2). Primary outcome measure was the Panic Disorder Severity Scale-Self Report. A total of 114 participants suffering from panic attacks (mean age 42 years; 78% female) entered the study. Results The course participants showed a significant effect on the outcome measures at follow-up. Large effect sizes were found on panic symptoms, on symptoms of agoraphobia and on mental health-related quality of life at T1 and T2. Overall, the course leaders and the participants evaluated the course positively. There were no significant differences in outcome measures between the short and the long version of the course. Conclusion The study suggests that people with sub-threshold PD and mild PD could benefit from this preventive intervention and that the intervention might be feasible. Furthermore, the short version could be as effective as the long version

Cost-utility of a visiting service for older widowed individuals: Randomised trial

Background. Despite a growing understanding of the effectiveness of bereavement interventions and the groups that benefit most from them, we know little about the cost-effectiveness of bereavement interventions. Methods. We conducted a cost-utility analysis alongside a randomized clinical trial on a visiting service for older widowed individuals (n = 110) versus care as usual (CAU; n = 106). The visiting service is a selective bereavement intervention that offers social support to lonely widows and widowers by a trained volunteer. Participants were contacted 6-9 months post-loss. Eleven percent of all contacted persons responded and eight percent participated in the trial. The primary outcome measure was quality adjusted life years (QALYs) gained (assessed with the EQ-5D), which is a generic measure of health status. Costs were calculated from a societal perspective excluding costs arising from productivity losses. Using the bootstrap method, we obtained the incremental cost utility ratio (ICUR), projected these on a cost-utility plane and presented as an acceptability curve. Results. Overall, the experimental group demonstrated slightly better results against slightly higher costs. Whether the visiting service is acceptable depends on the willingness to pay: at a willingness to pay equal to zero per QALY gained, the visiting service has a probability of 31% of being acceptable; beyond €20,000, the visiting service has a probability of 70% of being more acceptable than CAU. Conclusion. Selective bereavement interventions like the visiting service will not produce large benefits from the health economic point of view, when targeted towards the entire population of all widowed individuals. We recommend that in depth analyses are conducted to identify who benefits most from this kind of interventions, and in what subgroups the incremental cost-utility is best. In the future bereavement interventions are then best directed to these groups. Trial registration. Controlled trials ISRCTN17508307. © 2008 Onrust et al; licensee BioMed Central Ltd

Cost-effectiveness of preventing depression in primary care patients Randomised trial

Background Littleisknown aboutthe cost-effectiveness of preventingmental disorders. Aims To study the cost-effectiveness of care asusualplusminimal contact psychotherapyrelative to usual care alone inpreventingdepressive disorder. Method An economic evaluationwas conducted alongside a randomised clinical trial.Primarycare patientswith subthreshold depressionwere assignedto minimal contactpsychotherapyplususual care (n¼107) or to usual care alone (n¼109). Results Primarycarepatientswithsubthreshold depression benefited from minimal contactpsychotherapy asit reducedthe riskofdevelopinga full-blown depressive disorder from18% to12%.In addition, this interventionhad a 70% probabilityof beingmore cost-effective thanusual care alone.Asensitivityanalysis indicatedthe robustness of these results. Conclusions Over1year adjunctive minimal contactpsychotherapyimproved outcomes and generatedlower costs.This interventionis therefore superior to usual care aloneinterms of cost-effectiveness

Minimal contact psychotherapy for sub-threshold depression in primary care: a randomised trial.

Background: Sub-threshold depression is a prognostic variable for major depression. Interventions in sub-threshold depression may prevent the onset of new cases of major depression. Aims: To examine the effects of minimal-contact psychotherapy in primary care patients with sub-threshold depression on the onset of major depression, on the reduction in depressive symptoms and on health-related quality of life. Method: We conducted a randomised trial in primary care, in which patients screened for sub-threshold depression were randomly assigned to minimal-contact psychotherapy (n = 107) or to usual care (n = 109). Results: One year after baseline, the incidence of major depressive disorder was found to be significantly lower in the psychotherapy group (12%) than in those receiving usual care (18%). Small but significant effects were also found on depressive symptoms and on aspects of health-related quality of life. Conclusions: Primary care patients with sub-threshold depression can benefit from minimal-contact psychotherapy