|- candidate number||21588|
|- NTR Number||NTR4992|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jan-2015|
|- Secondary IDs||NL49574.072.14 2014 6834|
|- Public Title||Behandeleffecten van een kortdurende intensieve behandeling (8 dagen) van obsessief compulsieve stoornis en paniekstoornis bij patienten die nonresponder zijn op een eerdere cognitieve gedragstherapeutische behandeling.|
|- Scientific Title||Short Intensive 8-day CBT for CBT nonresponders with obsessive-compulsive disorders or panic disorder: an effect study|
|- Healt Condition(s) or Problem(s) studied||Panic disorder, Obsessive-compulsive disorder (OCD), Intensive CBT|
|- Inclusion criteria||A primary diagnosis of panic disorder or obsessive-compulsive disorder according to the DSM IV(assessed with the MINI, Sheehan et al 1998; Overbeek et al.,1999).
Age between 18-70.
Patients have had an adequate CBT treatment. An adequate CBT treatment is defined as CBT with exposure and response prevention with most weekly sessions for at least a period of 12 weeks for panic disorder and 20 weeks for OCD.
Patients still have significant symptoms and did not experience a significant change in symptoms. Significant symptoms are defined as a score of at least 11 on the Panic Disorder Severity Scale (PDSS; Shear et al., 1992) or a score of at least 10 when the diagnosis is panic disorder without agoraphobia, and a score of at least 4 on the Clinical Global Impression (CGI; Guy, 1976). Significant symptoms for OCD are defined as a score of at least 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; Goodman, 1989) or a score of at least 10 when the diagnosis is primary obsessions, and a score of at least 4 on the Clinical Global Impression (CGI; Guy, 1976).
Concurrent use of antidepressants is allowed, doses have to be kept constant during the study. PD patients have to be on a constant dose 2 months before the study, OCD patient have to be on a constant dose 3 months before the study.
Concurrent use of benzodiazepines is allowed, when kept on a constant dose and taken at fixed times and not exceed the equivalence of 30 mg oxazepam.|
|- Exclusion criteria||Severe, unstable mental disorder like depressive disorder or risk of suicide, psychotic disorder or bipolar disorder (assessed with the MINI);
Comorbid diagnosis of hoarding;
Patient is not able to focus on treatment for 2 weeks because of social problems;
Inability to read, write and speak in the Dutch language;
Patient will not be able to taper off drug or alcohol use before treatment.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||15-feb-2015|
|- planned closingdate||15-jun-2017|
|- Target number of participants||20|
|- Interventions||In the present study, intensive CBT treatment will be delivered in 8 days (in two weeks). CBT will take place in different locations, at home, in public transportation, etc. After the intensive phase, patients will receive 4 boostersessions of 90 minutes during 4 weeks and an evaluation session.
There is a baseline phase, which is the control for the active fase.|
|- Primary outcome||OCD or panic disorder symptoms|
|- Secondary outcome||Depressive symptoms, general functionig and quality of life.|
|- Timepoints||The study consists of 4 phases, the baseline phase, the intervention phase, the post-intervention phase and the follow-up.
During the total study duration of 19 weeks patients have weekly assessments of their main symptoms.
Before and after every phase the secondary outcome measures are assessed (4 assessments in total).|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| M Kampman |
|- CONTACT for SCIENTIFIC QUERIES|| M Kampman |
|- Sponsor/Initiator ||Pro Persona|
(Source(s) of Monetary or Material Support)
|Fonds Psychische Gezondheid|
|- Brief summary||Patients, who are non-responding on CBT for panic disorder of obsessive-compulsive disorder will receive an intensive 8-day CBT, followed by 4 weekly booster sessions. The study usus a multiple baseline design. Pirmary symptoms are assessed in 4 phases.
The patients are recuited in The Netherlands|
|- Main changes (audit trail)|
|- RECORD||19-jan-2015 - 3-apr-2015|