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Prevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study.


- candidate number1162
- NTR NumberNTR99
- ISRCTNISRCTN33407455
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR1-aug-2005
- Secondary IDs63-438 
- Public TitlePrevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study.
- Scientific TitlePrevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study.
- ACRONYMN/A
- hypothesisThe preventive group course "No Panic" would show superior effects in lowering the incidence of panic disorder, reducing panic symptoms, improving quality of life and reduced economic costs, compared with a waiting-list control group.
- Healt Condition(s) or Problem(s) studiedMental illness, Panic disorder
- Inclusion criteriaPersons aged 18-65 with subclinical panic disorder (symptoms), with or without symptoms of agoraphobia.
- Exclusion criteria1. Score of 13 or higher on the Panic Disorder Severity Scale (PDSS);
2. DSM-IV diagnosis of panic disorder;
3. Comorbid severe depressive disorder (DSM-IV);
4. Comorbid other mental or social problems that deserve priority;
5. Language or learning difficulties;
6. Not be able to function in a group;
7. Insufficient intellectual capabilities to follow the course;
8. Cardiological treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-jul-2007
- Target number of participants286
- InterventionsExperimental condition: the preventive group course "No Panic". This intervention is based on cognitive-behavioural therapy proved to be effective for patients with a full-blown panic disorder. The course consists of 8 sessions of 2 hours each (session 1-6 are weekly, session 7-8 are 2-weekly).
Control condition: waiting-list condition. Respondents assigned to this condition receive the course after the experimental group.
- Primary outcomeIncidence of DSM-IV panic disorder.
- Secondary outcome1. Panic symptoms;
2. Quality of life;
3. Economic costs.
- TimepointsN/A
- Trial web sitehttp://www.cursusgeenpaniek.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. G. Willemse
- CONTACT for SCIENTIFIC QUERIESDr. G. Willemse
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction, VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryPanic disorder is a severe and persistent mental disorder, associated with a high degree of subjective distress, occupational and social disability. In the Netherlands, each year 242.000 peope aged 18-65 years suffer from panic disorder. A promising intervention aimed at preventing panic disorder and reducing panic symptoms, is the Dutch cognitive-behavioural group course "No Panic". In this trial, respondents are randomly assigned to the group course "No Panic" or to the waiting-list condition, in which the course will be offered later. Data will be collected prior to the intervention, after the intervention and after 6 months. We predict that the experimental condition would show superior effects in lowering the incidence of panic disorder, reducing panic symptoms, improving quality of life and reducing economic costs.
- Main changes (audit trail)
- RECORD1-aug-2005 - 1-dec-2009


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