|- candidate number||2117|
|- NTR Number||NTR699|
|- Date ISRCTN created||19-jul-2006|
|- date ISRCTN requested||4-jul-2006|
|- Date Registered NTR||6-jun-2006|
|- Secondary IDs||N/A |
|- Public Title||The effectiveness of cognitive behavioural therapy vs. interpersonal psychotherapy in panic disorder with agoraphobia.|
|- Scientific Title||The effectiveness of cognitive behavioural therapy vs. interpersonal psychotherapy in panic disorder with agoraphobia.|
|- hypothesis||In this study we will test the effectivity of CBT vs. IPT in panic disorder with agoraphobia.|
|- Healt Condition(s) or Problem(s) studied||Panic disorder, Agoraphobia|
|- Inclusion criteria||1. Main diagnosis panic disorder with moderate/severe agoraphobia; |
2. aged between 18 and 60.
|- Exclusion criteria||1. Co morbid psychosis or bipolar disorder;|
2. the use of psychoactive drugs;
3. Intelligence Quotient (IQ) < 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;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||18-sep-1996|
|- planned closingdate||23-okt-2006|
|- Target number of participants||92|
|- Interventions||Patients will receive 12 therapeutic sessions of either cognitive behavioural therapy (CBT) or interpersonal psychotherapy (IPT). Once a week a session takes place and one session takes one hour. |
|- Primary outcome||1. Panic free status (defined with panic diaries);|
2. performance on a behavioural test (3 situations).
Panic diaries are completed at 0 months (pre-treatment), during treatment, 3 months (post treatment), 4 months (follow up 1) and 9 months (follow up 2).
Performance on the behavioural test is assessed at 0 months (pre-treatment), 4 months (follow up 1) and 9 months (follow up 2).
|- Secondary outcome||1. A composite measure of panic and agoraphobic measures (FQ v+a, main fobia, ASI, FOF, …);|
2. a composite measure of cognitive measures (e.g. BSIQ-14, ACQ);
3. an interpersonal measure (IIP);
4. a composite measure of general psychopathology (SCL-90, STAI).
The outcomes are assessed at 0 months (pre-treatment), 3 months (post treatment), 4 months (follow up 1) and 9 months (follow up 2).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Linsey Diels|
|- CONTACT for SCIENTIFIC QUERIES|| Arnoud Arntz|
|- Sponsor/Initiator ||University Maastricht (UM), Research Institute Experimental Psychopathology (EPP), Department of Clinical, Medical, and Experimental Psychology|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM), Research Institute Experimental Psychopathology (EPP), Department of Clinical, Medical, and Experimental Psychology|
|- Brief summary||In panic disorder with agoraphobia, CBT is an effective empircal based treatment approach in which exposure in vivo and cognitive therapy are important components. IPT appears to be an efficacious treatment in depressive disorder, eating disorders, PTSD, and social phobia. These good treatment results and the finding that panic disorders may occur in times of increased interpersonal stress, generate questions about the superior status of CBT in treating panic patients with agoraphobia.|
|- Main changes (audit trail)|
|- RECORD||6-jun-2006 - 9-sep-2009|