The effectiveness of cognitive behavioural therapy versus interpersonal psychotherapy in panic disorder with agoraphobia

ISRCTN ISRCTN95465806
DOI https://doi.org/10.1186/ISRCTN95465806
Secondary identifying numbers NL639, NTR699
Submission date
19/07/2006
Registration date
19/07/2006
Last edited
08/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Linsey Diels
Scientific

University Maastricht (UM)
P.O.Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3881264
Email L.Diels@dmkep.unimaas.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effectiveness of cognitive behavioural therapy versus interpersonal psychotherapy in panic disorder with agoraphobia
Study objectivesIn this study, we will test the effectiveness of Cognitive Behavioural Therapy (CBT) versus Interpersonal PsychoTherapy (IPT) in panic disorder with agoraphobia.
Ethics approval(s)Ethics Board of the Community Mental Health Centre Maastricht, ethic approval granted on the 30th September 1996 (ref: GWA 96.070)
Health condition(s) or problem(s) studiedPanic disorder, agoraphobia
InterventionPatients 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date18/09/1996
Completion date23/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants92
Total final enrolment91
Key inclusion criteria1. Main diagnosis panic disorder with moderate/severe agoraphobia
2. Aged between 18 and 60
Key exclusion criteria1. 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
Date of first enrolment18/09/1996
Date of final enrolment23/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Research Institute Experimental Psychopathology (EPP) (The Netherlands)
Research organisation

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

ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 08/01/2021 Yes No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.