Condition category
Mental and Behavioural Disorders
Date applied
04/09/2012
Date assigned
09/10/2012
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.zonmw.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes