Condition category
Mental and Behavioural Disorders
Date applied
08/01/2010
Date assigned
17/02/2010
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hans-Helmut König

ORCID ID

Contact details

University of Leipzig
Health Economics Research Unit
Department of Psychiatry
Liebigstr. 26
Leipzig
04103
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

93200-061

Study information

Scientific title

Cost-effectiveness of an optimised care model for patients with anxiety disorders in primary care: a cluster randomised controlled trial

Acronym

Study hypothesis

Many patients with anxiety disorders do not receive accurate diagnosis or adequate treatment in primary care and cause high medical costs due to costly medical testing or the use of inappropriate and expensive emergency services. The main aim was to analyse the cost-effectiveness of an optimised care model for anxiety disorders in primary care that consisted of an intervention primarily targeted at primary care physicians.

Ethics approval

Study protocol was approved by the ethics committee of the University of Leipzig in August 2004

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Anxiety disorders

Intervention

The intervention consisted of a specific training for GPs combined with an offer of consultation to the GPs for specific anxiety patients. The intervention aimed at improving GPs’ diagnostic and therapeutic knowledge and skills through a cognitive behavioural therapy (CBT) approach as used in psychiatry.
Follow-up occurred at 6-months and 9-months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Beck’s Anxiety Inventory (BAI)
2. Direct costs (raised with German Version of Client Sociodemographic and Service Receipt [CSSRI])

Secondary outcome measures

1. WHO Quality of Life Assessment (WHOQOL BREF)
2. Health outcomes questionnaire (EQ-5D)
3. Beck’s Depression Inventory (BDI)
4. Indirect costs (raised with German Version of Client Sociodemographic and Service Receipt [CSSRI])

Overall trial start date

01/08/2005

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients screened positive for one of the following anxiety disorders according to the criteria of the World Health Organization (WHO) International Classification of Diseases - version 10 (ICD-10):
1.1. Social phobias (F40.1)
1.2. Panic disorder [episodic paroxysmal anxiety] (F41.0)
1.3. Generalized anxiety disorder (F41.1)
1.4. Anxiety disorder, unspecified (F41.9)
Evaluated by German version of the Patient Health Questionnaire (PHQ-D)
2. Between 18 and 65 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

389 respondents at baseline - intervention group (201 patients in 23 practices); control group (188 patients in 23 practices)

Participant exclusion criteria

1. Terminally ill
2. Suicidal
3. Cognitively impaired
4. Insufficient command of the German language

Recruitment start date

01/08/2005

Recruitment end date

30/04/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University of Leipzig
Leipzig
04103
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (Germany)

Sponsor details

Projektträger im DLR
Heinrich-Konen-Straße 1
Bonn
53227
Germany

Sponsor type

Government

Website

http://www.dlr.de/pt

Funders

Funder type

Government

Funder name

German Centre for Aerospace (Deutsches Zentrum für Luft- und Raumfahrt e.V.) (ref: DLR/01GL0502)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/19794198
2. Matschinger H, Roick C, Heider D, Riedel-Heller SG, Surall D, Born A, Angermeyer MC, König HH. Zur Evaluation von cluster-randomisierten Studien durch Wachstumskurven Modelle [To evaluate cluster-randomized trials of growth curve models]. Klinische Diagnostik und Evaluation. 2009 4; 2: 310-326. [Article in German]
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20444251

Publication citations

  1. Results

    König HH, Born A, Günther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C, Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders., Health Qual Life Outcomes, 2010, 8, 47, doi: 10.1186/1477-7525-8-47.

  2. König HH, Born A, Heider D, Matschinger H, Heinrich S, Riedel-Heller SG, Surall D, Angermeyer MC, Roick C, Cost-effectiveness of a primary care model for anxiety disorders., Br J Psychiatry, 2009, 195, 4, 308-317, doi: 10.1192/bjp.bp.108.058032.

Additional files

Editorial Notes