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
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