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ISRCTN
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ISRCTN15716049
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ClinicalTrials.gov identifier
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Public title
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Cost-effectiveness of an optimised care model for patients with anxiety disorders in primary care
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Scientific title
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Cost-effectiveness of an optimised care model for patients with anxiety disorders in primary care: A cluster randomised controlled trial
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Acronym
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N/A
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Serial number at source
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93200-061
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Study protocol was approved by the ethics committee of the University of Leipzig in August 2004
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Study design
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Cluster randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Anxiety disorders
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Terminally ill
2. Suicidal
3. Cognitively impaired
4. Insufficient command of the German language
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Anticipated start date
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01/08/2005
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Anticipated end date
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30/04/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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389 respondents at baseline - intervention group (201 patients in 23 practices); control group (188 patients in 23 practices)
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Interventions
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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.
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Primary outcome measure(s)
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1. Beck’s Anxiety Inventory (BAI)
2. Direct costs (raised with German Version of Client Sociodemographic and Service Receipt [CSSRI])
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Secondary outcome measure(s)
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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])
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Sources of funding
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1. German Centre for Aerospace (Deutsches Zentrum für Luft- und Raumfahrt e.V.) (ref: DLR/01GL0502)
2. Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF])
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Trial website
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Publications
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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
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Contact name
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Prof
Hans-Helmut
König
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Address
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University of Leipzig
Health Economics Research Unit
Department of Psychiatry
Liebigstr. 26
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City/town
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Leipzig
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Zip/Postcode
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04103
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Country
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Germany
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Sponsor
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Federal Ministry of Education and Research (Germany)
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Address
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Projektträger im DLR
Heinrich-Konen-Straße 1
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City/town
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Bonn
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Zip/Postcode
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53227
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Country
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Germany
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Sponsor website:
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http://www.dlr.de/pt
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Date applied
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08/01/2010
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Last edited
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04/11/2010
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Date ISRCTN assigned
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17/02/2010
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