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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR99 |
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Date of registration:
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01/08/2005 |
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Primary sponsor: |
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Public title:
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Prevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study.
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Scientific title:
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Prevention of panic disorder: A randomised clinical trial adjoining cost-effectiveness study. - N/A |
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Date of first enrolment:
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1/9/2005 |
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Target sample size:
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286 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=99 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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G.
Willemse |
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Address:
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Trimbos Institute - Netherlands Institute of Mental Health and Addiction,
P.O.Box 725, Da Costakade 45
3500 AS
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2971100 |
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Email:
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gwillemse@trimbos.nl |
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Affiliation:
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Name:
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G.
Willemse |
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Address:
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Trimbos Institute - Netherlands Institute of Mental Health and Addiction,
P.O.Box 725, Da Costakade 45
3500 AS
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2971100 |
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Email:
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gwillemse@trimbos.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Mental illness, Panic disorder
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Intervention(s)
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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.
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Primary Outcome(s)
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Incidence of DSM-IV panic disorder.
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Secondary Outcome(s)
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1. Panic symptoms;
2. Quality of life;
3. Economic costs.
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Secondary ID(s)
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63-438
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ISRCTN33407455
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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