| - candidate number | 1162 |
| - NTR Number | NTR99 |
| - ISRCTN | ISRCTN33407455 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 1-aug-2005 |
| - Secondary IDs | 63-438 |
| - Public Title | Prevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study. |
| - Scientific Title | Prevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study. |
| - ACRONYM | N/A |
| - hypothesis | The 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) studied | Mental illness, Panic disorder |
| - Inclusion criteria | Persons aged 18-65 with subclinical panic disorder (symptoms), with or without symptoms of agoraphobia. |
| - Exclusion criteria | 1. 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 received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-2005 |
| - planned closingdate | 1-jul-2007 |
| - Target number of participants | 286 |
| - Interventions | Experimental 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 outcome | Incidence of DSM-IV panic disorder. |
| - Secondary outcome | 1. Panic symptoms; 2. Quality of life; 3. Economic costs. |
| - Timepoints | N/A |
| - Trial web site | http://www.cursusgeenpaniek.nl |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Dr. G. Willemse |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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 |
| - Publications | N/A |
| - Brief summary | Panic 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) | |
| - RECORD | 1-aug-2005 - 1-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl