Prevention of panic disorder: a randomised clinical trial adjoining cost-effectiveness study
| ISRCTN | ISRCTN33407455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33407455 |
| Protocol serial number | 63-438 |
| Sponsor | Trimbos Institute (Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 06/04/2010
- 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
Dr G Willemse
Scientific
Scientific
Trimbos Institute/Netherlands Institute of Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands
| Phone | +31 (0)30 297 1100 |
|---|---|
| gwillemse@trimbos.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 to 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 six 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. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Panic disorder, mental disorders |
| Intervention | 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 eight sessions of two hours each (session one to six are weekly, session seven to eight are two-weekly). Control condition: Waiting-list condition. Respondents assigned to this condition receive the course after the experimental group. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of DSM-IV panic disorder |
| Key secondary outcome measure(s) |
1. Panic symptoms |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 286 |
| Key inclusion criteria | 1. Aged 18 to 65 2. Subclinical panic disorder (symptoms), with or without symptoms of agoraphobia |
| Key exclusion criteria | 1. Score of 13 or higher on the Panic Disorder Severity Scale (PDSS) 2. Diagnostic and Statistical Manual of Mental Disorders - fourth edition (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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Trimbos Institute/Netherlands Institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands
3500 AS
Netherlands
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 | 24/04/2009 | Yes | No | |
| Results article | results | 01/04/2010 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
