Condition category
Mental and Behavioural Disorders
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
10/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Linsey Diels

ORCID ID

Contact details

University Maastricht (UM)
P.O.Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881264
L.Diels@dmkep.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

In this study, we will test the effectiveness of Cognitive Behavioural Therapy (CBT) versus Interpersonal PsychoTherapy (IPT) in panic disorder with agoraphobia.

Ethics approval

Ethics Board of the Community Mental Health Centre Maastricht, ethic approval granted on the 30th September 1996 (ref: GWA 96.070)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Panic disorder, agoraphobia

Intervention

Patients will receive 12 therapeutic sessions of either cognitive behavioural therapy (CBT) or interpersonal psychotherapy (IPT), one session per week, each session takes one hour.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Panic free status (defined with panic diaries)
2. Performance on a behavioural test (three situations)

Panic diaries are completed at zero months (pre-treatment), during treatment, three months (post treatment), four months (follow up one) and nine months (follow up two).

Performance on the behavioural test is assessed at zero months (pre-treatment), four months (follow up one) and nine months (follow up two).

Secondary outcome measures

1. A composite measure of panic and agoraphobic measures (the Fear Questionnaire [FQ v+a], main phobia, Anxiety Sensitivity Index [ASI], Fear Of Fear [FOF], etc.,)
2. A composite measure of cognitive measures (e.g. Body Sensations Interpretation Questionnaire [BSIQ-14], Agoraphobic Cognitions Questionnaire [ACQ])
3. An interpersonal measure (the Inventory of Interpersonal Problems [IIP])
4. A composite measure of general psychopathology (the Symptom CheckList-90-R [SCL-90], State-Trait Anxiety Inventory [STAI])

The outcomes are assessed at zero months (pre-treatment), three months (post treatment), four months (follow up one) and nine months (follow up two).

Overall trial start date

18/09/1996

Overall trial end date

23/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Main diagnosis panic disorder with moderate/severe agoraphobia
2. Aged between 18 and 60

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

92

Participant exclusion criteria

1. Co-morbid psychosis or bipolar disorder
2. The use of psychoactive drugs
3. Intelligence Quotient (IQ) less than 80
4. Insufficient knowledge of the Dutch language
5. Previous formal IPT or CBT received (for the same complaint in the past year)
6. Alcohol or drugs dependency
7. Cardiovascular disease
8. Respiratory disease
9. Epilepsy

Recruitment start date

18/09/1996

Recruitment end date

23/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

Research Institute Experimental Psychopathology (EPP) (The Netherlands)

Sponsor details

Department of Clinical
Medical
and Experimental Psychology
P.O.Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

University/education

Funder name

University Maastricht (UM), Research Institute Experimental Psychopathology (EPP), Department of Clinical, Medical, and Experimental Psychology (The 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