Cost-effectiveness of an optimised care model for patients with anxiety disorders in primary care
| ISRCTN | ISRCTN15716049 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15716049 |
| Protocol serial number | 93200-061 |
| Sponsor | Federal Ministry of Education and Research (Germany) |
| Funders | German Centre for Aerospace (Deutsches Zentrum für Luft- und Raumfahrt e.V.) (ref: DLR/01GL0502), Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) |
- Submission date
- 08/01/2010
- Registration date
- 17/02/2010
- Last edited
- 14/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hans-Helmut König
Scientific
Scientific
University of Leipzig
Health Economics Research Unit
Department of Psychiatry
Liebigstr. 26
Leipzig
04103
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Cost-effectiveness of an optimised care model for patients with anxiety disorders in primary care: a cluster randomised controlled trial |
| Study objectives | 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(s) | Study protocol was approved by the ethics committee of the University of Leipzig in August 2004 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Becks Anxiety Inventory (BAI) |
| Key secondary outcome measure(s) |
1. WHO Quality of Life Assessment (WHOQOL BREF) |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 389 |
| Key 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 |
| Key exclusion criteria | 1. Terminally ill 2. Suicidal 3. Cognitively impaired 4. Insufficient command of the German language |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Leipzig
Leipzig
04103
Germany
04103
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | Yes | No | |
| Results article | results on cost effectiveness | 01/10/2009 | Yes | No | |
| Results article | results | 05/05/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
