Condition category
Mental and Behavioural Disorders
Date applied
14/09/2012
Date assigned
07/11/2012
Last edited
01/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Panic disorder is a common anxiety disorder. Symptoms include dizziness, chest pain, weakness, tremors, sweating or shortness of breath. Those affected often do not know what is happening to them during panic attacks and they may worry about being physically ill or "going crazy". They also fear that a panic attack is going to occur again, so many start to avoid certain places or situations where they feel uncomfortable or are afraid they may become anxious. This avoidance behaviour is called "agoraphobia". Agoraphobia and panic disorder can strongly interfere with work life and personal relationships, and lead to high emotional distress and considerable costs to society. The 'Jena-Paradies' study is aimed at improving the treatment of panic disorder and agoraphobia by family doctors at local surgeries, where most patients are treated by family doctors. The 'Jena-Paradies' study is aimed at developing and testing a practice team-supported training program for these patients. The main goals of this training program are to reduce the symptoms of anxiety and to improve quality of life.

Who can participate?
Adult patients of both sexes who suffer from panic disorder with or without agoraphobia and who are willing to participate voluntarily.

What does the study involve?
All participating family doctors will be trained to give the standard treatment for panic disorder with or without agoraphobia. Training sessions will take place at the Institute of General Practice and Family Medicine (Jena University Hospital). Trained family doctors will be asked to find eligible patients from their practices by using questionnaires. Two groups of family practices will then be created. One group will treat patients as usual (providing 'usual care' which meets current recommended standards). The other group will have additional training sessions in applying the 'Jena-Paradies' program. During the training sessions, the family doctor will be trained, as well as a health care assistants from their practice, which will from the 'practice team', and will together provide the 'Jena-Paradies' training program. Patients in this group will receive a self-help manual which contains information about anxiety disorders and treatment. The patient will take part in to face anxiety-provoking activities and situations via exercises given to them by the doctor. These exercises enable patients to overcome their anxiety or fear in small steps. The health care assistant will provide patients with sustainable support during the course of the whole treatment and will make periodic telephone calls to the patients. During these calls, the health care assistant will ask certain questions to monitor anxiety symptoms and treatment progress. The answers will be reported to the doctor, so that he can quickly react to treat the patient if necessary (for example, make another appointment with the patient). This also allows the safety of the patient to be monitored, and enhances the quality of treatment.

What are the possible benefits and risks of participating?
Participants with anxiety disorders will hopefully experience less symptoms. There are no known risks associated with taking part in this study. However, the training program will require patients to take an active role during treatment. For instance they will be asked to read the self-help manual, to focus anxiety provoking situations, and to complete certain exercises to overcome their anxiety.

Where is the study run from?
Institute of General Practice and Family Medicine at Jena University Hospital

When is the study starting and how long is it expected to run for?
The study will start in October 2012 and will end in June 2016. The training program will take six months for every patient to complete, but patients are required to participate for twelve months as they will be asked to complete study-related questionnaires at three time points within these twelve months.

Who is funding the study?
Federal Ministry of Education and Research (BMBF), ref: 01GY1146.

Who is the main contact?
Prof Jochen Gensichen
Jena-Paradies@med.uni-jena.de 

Trial website

http://www.jena-paradies.org

Contact information

Type

Scientific

Primary contact

Prof Jochen Gensichen

ORCID ID

Contact details

Prinzipal Investigator
Institute of General Practice and Family Medicine
Jena University Hospital
Friedrich Schiller University
Bachstr. 18
Jena
D-07743
Germany
+49 (0)3641 9395800
jochen.gensichen@med.uni-jena.de

Type

Scientific

Additional contact

Mr Thomas S Hiller

ORCID ID

Contact details

Institute of General Practice and Family Medicine
Jena University Hospital
Friedrich-Schiller-University
Bachstr. 18
Jena
D-07743
Germany
+49 (0)3641 9395816
Thomas.Hiller@med.uni-jena.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

German Clinical Trials Register (DRKS) No. DRKS00004386

Study information

Scientific title

Evaluation of a practice team-supported, self-managed exposure training for patients with panic disorder and agoraphobia in primary care [Jena-PARADISE (Patient Activation foR Anxiety DISordErs)]

Acronym

Jena-PARADISE

Study hypothesis

A practice team-supported, self-managed exposure training for patients with panic disorder with or without agoraphobia in primary care yields significantly greater reductions in anxiety symptoms than 'usual care' plus recommended standard after six months of treatment.

Ethics approval

Jena University Hospital Ethics Committee, ref: 3484-063/12

Study design

Prospective controlled two-armed multi-centered cluster-randomized interventional trial. Clusters (family practices) will be assigned to the study arms following a computer supported randomization

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

http://www.jena-paradies.org

Condition

Panic Disorder and Panic Disorder with Agoraphobia

Intervention

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 (APA 2009, DGPPN 2000, NICE 2011).
Only in the intervention arm of the study practice teams (i.e. in each case the GP and one of the health care assistants from his practice, HCA) will additionally be trained in applying the practice team-supported, self-directed exposure training (i.e. the Jena-PARADISE training program). The practice team-supported, self-directed exposure training will be carried out in terms of a Case Management. It will include 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.
In both arms of the study 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)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

Current secondary outcome measures as of 04/02/2014:
1. Anxiety-related reduction of mobility (MI); T1/T2
2. Number and severity of panic attacks (PAS, Items A1 and A2)
3. Depressiveness (PHQ-9); T1/T2
4. Health-related quality of life (EQ-5D); T1/T2
5. Quality Adjusted Life Years (EQ-5D); T1/T2
6. Direct and indirect costs from a societal perspective; T1/T2
7. Incremental Cost-Effectiveness Ratio (ICER); T1/T2

Previous secondary outcome measures:
1. Anxiety-related reduction of mobility (MI); T1/T2
2. Anxiety-related cognitions (ACQ); T1/T2
3. Anxiety sensitivity (ASI-3); T1/T2
4. Anxiety severity and psychosocial impairments (Brief OASIS); T1/T2
5. Number and severity of panic attacks (PAS, Items A1 and A2)
6. Depressiveness (PHQ-9); T1/T2
7. Patient activation (PAM); T1/T2
8. Health-related quality of life (EQ-5D); T1/T2
9. Quality Adjusted Life Years (EQ-5D); T1/T2
10. Direct and indirect costs from a societal perspective; T1/T2
11. Incremental Cost-Effectiveness Ratio (ICER); T1/T2

Overall trial start date

01/10/2012

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (> 18 years)
2. Panic disorder with or without agoraphobia (ICD-10: F.41.0 or F40.01)
3. Positive screening questionnaires
4. Sufficient German language skills
5. Private telephone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The study shall include 444 participants (observational units) from 74 family practices (study centers / clusters).

Participant exclusion criteria

1. Acute suicidality
2. Acute or chronic psychosis
3. Drug or alcohol dependence
4. Severe physical illness
5. Pregnancy
6. Current psychotherapeutic treatment of anxiety

Recruitment start date

01/10/2012

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Institute of General Practice and Family Medicine
Jena University Hospital Friedrich-Schiller-University Bachstr. 18
Jena
D-07743
Germany

Trial participating centre

76 German general practices
-
Germany

Sponsor information

Organisation

Jena University Hospital (Germany)

Sponsor details

Institute of General Practice and Family Medicine
Jena University Hospital
Friedrich Schiller University
Bachstr. 18
Jena
D-07743
Germany
+49 (0)3641 9395800
allgemeinmedizin@med.uni-jena.de

Sponsor type

University/education

Website

http://www.allgemeinmedizin.uni-jena.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24708672

Publication citations

  1. Protocol

    Gensichen J, Hiller TS, Breitbart J, Teismann T, Brettschneider C, Schumacher U, Piwtorak A, König HH, Hoyer H, Schneider N, Schelle M, Blank W, Thiel P, Wensing M, Margraf J, Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial., Trials, 2014, 15, 112, doi: 10.1186/1745-6215-15-112.

Additional files

Editorial Notes

On 01/03/2016 the overall trial end date was changed from 31/12/2015 to 30/06/2016. On 21/04/2015 the overall trial end date was changed from 28/02/2015 to 31/12/2015.