German Clinical Trials Register

Acronym/abbreviation of the study

PARADISE (Patient Activation foR Anxiety DISordErs)

URL of the study

http://www.jena-paradies.org

Brief summary in lay language

About 14 percent of Germans suffer from anxiety disorders in which severe anxiety reactions occur, although in fact there is no danger for the individual. Anxiety reactions are generally harmless, but often associated with physical ailments (including heart palpitations, trembling, shortness of breath). For this reason many patients mistakenly believe that they were physically ill. Anxiety disorders can strongly interfere with work life and personal relationships, thereby leading to high emotional distress and considerable costs to society. In a third of cases the anxiety disorder is treated exclusively by the family doctor. Not less than 5 percent of the patients in a German family practice suffer from the specific anxiety disorders "Panic Disorder" and "Agoraphobia". The goal of the "Jena-Paradies”-study is to develop and test practice team-supported training program for these primary care patients. As part of the "Jena-Paradies" training program, patients will firstly learn to understand the anxiety disorder. The family doctor will then provide patients with a number of behavioral therapy-oriented tasks (exercises). These well-proven exercises have already helped many other patients to overcome their anxiety disorder. During the whole treatment patients will be accompanied and supported by the family doctor and by one of his health care assistants. They both form the practice team. A number of well-structured personal appointments and telephone contacts between the patient and the practice team will take place. Additionally patients will receive a self-help manual to support the training program. It is expected that there will be greater decreases in anxiety symptoms when patients are treated by means of the "Jena-Paradies” training program as if they are treated by the family doctor “as usual”. To scientifically test this expectation two groups of participating family practices will be created during the course of the study: One group will treat the patients by means of the "Jena-Paradies" training program and the other will treat them as usual (without using the training program). Within the course of twelve months, all patients will be asked about their health per questionnaire at three timepoints. The two groups will be statistically compared in terms of patient health and treatment costs.

Brief summary in scientific language

Background: Panic disorder (ICD-10: F41.0) is a widespread anxiety disorder which is characterized by repeated panic attacks, where strong but harmless physical symptoms occur (like dizziness, chest pain, weakness, tremors, sweating or shortness of breath). Often sufferers do not know what is happening to them during panic attacks, for which reason they erroneously worry about being physically ill or "getting crazy". Above all, they fear that panic attacks are going to occur again. Due to this fear many of them start to avoid certain places or situations where they feel uncomfortable or are afraid to become anxious. This kind of avoidance behavior is called Agoraphobia (ICD-10: F 40.0). Agoraphobia is comorbid to Panic Disorder in 35-65 % of cases. Usually both disorders strongly interfere with work life and personal relationships, thereby leading to high emotional distress and considerable costs to society. At the same time evidence-based, effective treatment options are available. The “Jena-Paradies”-study is aimed at facilitating the treatment of panic disorder and agoraphobia in primary care as most of the patients are treated by family doctors. The primary treatment of anxiety disorders by means of behaviour-therapy-oriented procedures is recommended by international clinical guidelines (e.g. APA 2009, DGPPN 2000). Additionally, it has been shown that the treatment of chronic diseases can be optimized by methods derived from the Chronic Care Model. In line with this, a practice team-supported, self-managed exposure training for Panic Disorder and Agoraphobia in primary care will be evaluated by the "Jena-Paradies"-study. This training incorporates the recommended behavior therapy-oriented procedures and is carried out in terms of a practice team-based Case Management. Objectives: Comparing a practice team-supported, self-directed exposure training for panic disorder with/without agoraphobia in ambulant primary care patients to "Usual Care" plus recommended standard in terms of clinical effectiveness and health economic costs. Methods: This is a prospective, controlled two-armed, multi-centered, cluster-randomized interventional trial. Family practices will be assigned to the study arms following a computer supported randomization. 444 participants (observational units) from 74 family practices (Clusters) shall be included. Recruitment of patients will be carried out by the participating family practices. All participating investigators (general practitioners, GPs) will be trained in evidence based diagnostics and treatment of panic disorder with or without agoraphobia in accordance to recommended standards (DGPPN 2000). In the intervention arm of the study practice teams (i.e. the GP and one of his health care assistants, HCA) will additionally be trained in applying the practice team-supported, self-directed exposure training (i.e. the “Jena-Paradies” training program). The "Jena-Paradies" training program will be carried out in terms of a practice team-based Case Management. It includes the treatment elements counseling, psychoeducation, instructions for confrontation in vivo, and self-help manual. The treatment plan will comprise manualized behavior therapy oriented GP-consultations as well as protocol based HCA-telephone contacts. Anxiety symptoms and treatment progress will be monitored by the HCA using a special monitoring checklist (JA-MoL) during periodical telephone contacts. JA-MoL results will be reported to the GP who will be able to adjust treatment decisions according to them. In the control arm of the study GPs will provide patients with usual care in accordance to recommended standards. Treatment duration will be six months per patient. Outcomes: Outcome measurements will be carried out by questionnaires (patient self-report) at measurement points T0 (baseline before treatment start), T1 (26 +/- 4 weeks after baseline), and T2 (52 +/- 4 weeks after baseline). Estimation and significance testing of the baseline adjusted mean outcome group differences at T1 will be carried out by fitting a mixed linear model. Data of all patients will be analyzed in terms of an Intent-to-Treat analysis. Estimation and significance testing of treatment effects on secondary endpoints will be carried out by fitting mixed linear or generalized mixed linear models as appropriate.