Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
06/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http:\www.cursusgeenpaniek.nl

Contact information

Type

Scientific

Primary contact

Dr G Willemse

ORCID ID

Contact details

Trimbos Institute/Netherlands Institute of Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 297 1100
gwillemse@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

63-438

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of DSM-IV panic disorder

Secondary outcome measures

1. Panic symptoms
2. Quality of life
3. Economic costs

Overall trial start date

01/09/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 65
2. Subclinical panic disorder (symptoms), with or without symptoms of agoraphobia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

286

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos Institute/Netherlands Institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos Institute (Netherlands)

Sponsor details

Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19393084
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20357312

Publication citations

  1. Results

    Smit F, Willemse G, Meulenbeek P, Koopmanschap M, van Balkom A, Spinhoven P, Cuijpers P, Preventing panic disorder: cost-effectiveness analysis alongside a pragmatic randomised trial., Cost Eff Resour Alloc, 2009, 7, 8, doi: 10.1186/1478-7547-7-8.

  2. Results

    Meulenbeek P, Willemse G, Smit F, van Balkom A, Spinhoven P, Cuijpers P, Early intervention in panic: pragmatic randomised controlled trial., Br J Psychiatry, 2010, 196, 4, 326-331, doi: 10.1192/bjp.bp.109.072504.

Additional files

Editorial Notes