Trial document




drksid header

  DRKS00004386

Trial Description

start of 1:1-Block title

Title

Evaluation of a practice team-supported, self-managed exposure training for patients with panic disorder and agoraphobia in primary care

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PARADISE (Patient Activation foR Anxiety DISordErs)

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.jena-paradies.org

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.


end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004386
  •   2012/09/25
  •   2012/11/07
  •   yes
  •   Approved
  •   3484-06/12, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   ISRCTN64669297   (Current Controlled Trials)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F40.01 -  [generalization F40.0: Agoraphobia]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention condition: Treatment of patients with a practice team-supported, self-managed exposure program (after training of investigating general practitioners and associated health care assistants in its application). The general practitioner (GP) and the health care assistant (HCA) both form the practice team.
    The self-managed exposure program includes evidence-based, behavior therapy-oriented procedures (e.g. counseling, psychoeducation, instructions on confrontation in vivo, and self-help manual). It has to be applied in terms of a practice team-based Case Management. The treatment plan comprises three 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 checklist (Jena Anxiety Monitoring List, JAMoL) during periodical telephone contacts. JAMoL results will be reported directly to the GP who will be able to adjust treatment decisions according to them.
  •   Control condition: Treatment of patients with "Usual Care" in accordance with recommended standards (after training of investigators in diagnosis and irecommended treatment standards)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Severity of anxiety, measured by the Beck Anxiety Inventory (BAI, sum of scores at measurement point T1 six months after baseline)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

• Anxiety-related reduction of mobility (MI); T1/T2
• Number and severity of panic attacks (PAS, Items A1 and A2)
• Depressiveness (PHQ-9); T1/T2
• Health-related quality of life (EQ-5D); T1/T2
• Quality Adjusted Life Years (EQ-5D); T1/T2
• Direct and indirect costs from a societal perspective; T1/T2
• Incremental Cost-Effectiveness Ratio (ICER); T1/T2
T1: 26 weeks after baseline
T2: 52 weeks after baseline

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/08/28
  •   444
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Panic Disorder with or without Agoraphobia (ICD-10: F.41.0 or F40.01)
• positive screening questionnaires
• sufficient German language skills
• private telephone

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• acute suicidality
• acute or chronic psychosis
• drug or alcohol dependence
• severe physical illness
• pregnancy
• current psychotherapeutic treatment of anxiety

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Jena, Friedrich-Schiller-Universität Institut für Allgemeinmedizin
    • Mr.  Prof. Dr.  Jochen  Gensichen 
    • Bachstr. 18
    • D-07743  Jena
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Medizinische Soziologie, Sozialmedizin und Gesundheitsökonomie (IMSG) Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr.  Hans-Helmut  König 
    • Martinistr. 52
    • D-20246  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Jena, Friedrich-Schiller-Universität Institut für Allgemeinmedizin
    • Mr.  Thomas  Hiller 
    • Bachstr. 18
    • D-07743  Jena
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Jena, Friedrich-Schiller-Universität Institut für Allgemeinmedizin
    • Mr.  Thomas  Hiller 
    • Bachstr. 18
    • D-07743  Jena
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/02/17
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.