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

ISRCTN	ISRCTN95465806
DOI	https://doi.org/10.1186/ISRCTN95465806
Protocol serial number	NL639, NTR699
Sponsor	Research Institute Experimental Psychopathology (EPP) (The Netherlands)
Funder	University Maastricht (UM), Research Institute Experimental Psychopathology (EPP), Department of Clinical, Medical, and Experimental Psychology (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The effectiveness of cognitive behavioural therapy versus interpersonal psychotherapy in panic disorder with agoraphobia
Study objectives	In 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) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	23/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	92
Total final enrolment	91
Key inclusion criteria	1. Main diagnosis panic disorder with moderate/severe agoraphobia 2. Aged between 18 and 60
Key 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
Date of first enrolment	18/09/1996
Date of final enrolment	23/10/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Maastricht (UM)

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.