Plain English Summary
Background and study aims:
Panic disorder is a severe mental disease where patients experience (unexpected) frightful panic attacks. Most patients try to avoid these attacks by developing avoidance behaviour, e.g. they avoid crowded places. Panic disorder is also a burden for society as medical and social costs are high. Panic disorder treatment guidelines suggest cognitive behaviour therapy (CBT) or treatment with drugs, although CBT has known, longer lasting effects. Normally, CBT takes 10-12 weekly sessions, but CBT is not always easy available and waiting lists are long. Therefore, shorter and cheaper programs, such as guided self-help or internet based treatments have been tested and been successful in the treatment of panic disorder.
This study's goal is to examine whether a short program of guided self-help for panic disorder is beneficial, and only followed by more intensive treatment when necessary
Who can participate?
Patients with a panic disorder with or without agoraphobia. Either men or women, aged between 18-70 years.
What does the study involve?
130 patients (across different treatment centres) will be randomly allocated to one of two treatment conditions:
1. A brief CBT intervention (guided self-help) of 10 weeks followed by CBT (13 sessions) only when necessary
2. Treatment as usual according to the (NICE) guidelines
What are the possible benefits and risks of participating?
There are no negative risks known, since both treatment conditions are well studied and proven to be effective in the treatment for panic disorder. Benefits from enrolling in the study are the monitoring of symptoms and the adjustment of the therapy when necessary. A possible disadvantage is the extra time it may cost to fill in the extra questionnaires.
Where is the study run from?
Overwaal Nijmegen/Lent (part of ProPersona), The Netherlands (Lead Centre)
Hendriks & Roosenboom, private practice Arnhem, The Netherlands
Presenz (part of GgzIngeest), Amsterdam, The Netherlands
HSK Nijmegen en Den Bosch, The Netherlands
When is the study starting and how long is it expected to run for?
The study started in March 2009 and recruitment ended in March 2012. The last follow ups are expected at the end of 2012.
Who is funding the study?
ZONMW, The Netherlands.
Who is the main contact?
Dr Mirjam Kampman
m.kampman@propersona.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mirjam Kampman
ORCID ID
Contact details
Pro Persona
Pastoor van Laakstraat 48
Lent
6663 CB
Netherlands
+31 (0) 24 8200801
m.kampman@propersona.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100003034
Study information
Scientific title
Panic disorder intervention for panic disorder with or without agoraphobia [Stepped care interventie voor patienten met paniekstoornis met en zonder agorafobie]
Acronym
Study hypothesis
1. Guided self help is an effective first step in the treatment of panic disorder, compared with treatment as usual.
2. In the second step of the stepped care intervention, manualised CBT, panic disorder symptoms will be faster in remission as compared to the treatment as usual.
3. Symptom severity, duration of panic disorder, comorbidity on axis I and II will not predict treatment results of guided self help.
Ethics approval
Dutch Medical and Ethical Commission, Nijmegen, The Netherlands, 30 September 2008 ref: NL20312 09108
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet [Dutch]
Condition
Mental health, anxiety disorders, panic disorder, treatment studies
Intervention
This study consists of 2 conditions:
1. A first step of guided selfhelp, only when necessary followed by manualised CBT for panic disorder
2. Treatment as usual according to the NICE guidelines
Cognitive behaviour therapy, guided self help, psychopharmacology (in treatment as usual).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Panic and Agoraphobia Scale (PAS, Bandelow, 1999)
2. Outcome Questionnaire (OQ-45, Lambert and Burlingname, 2001)
Secondary outcome measures
1. Agoraphobic Cognition Questionnaire (ACQ, Chambless et al., 1984)
2. Mobility Inventory (MI, Chambless, et al., 1984)
3. Body Sensations Questionnaire (BSQ, Chambless, et al., 1984)
Overall trial start date
15/03/2009
Overall trial end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants have a present, primary diagnosis of panic disorder according to the DSM IV
2. Age between 18-70
3. Patiens give their informed consent
4. Patients are able to read and write the Dutch language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
1. A present diagnosis of schizophrenia or another psychotic disorder, according to the DSM-IV
2. Mental retardation, or another organic mental disorder
3. Suicidal ideation
4. Addiction to or abuse of drugs and/or alcohol
5. Another ongoing treatment for panic disorder (allthough the use of an SSRI or benzodiazepines is allowed in the treatment as usual condition)
Recruitment start date
15/03/2009
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Pro Persona
Lent
6663 CB
Netherlands
Sponsor information
Organisation
ZonMw (Netherlands)
Sponsor details
Postbus 93 245
Den Haag
2509 AE
Netherlands
+31 (0) 70 3495111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
ZonMw (Netherlands) ref: 100003034
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
ProPersona (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
Basic results (scientific)
Publication list