|- candidate number||4530|
|- NTR Number||NTR1537|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-nov-2008|
|- Secondary IDs||100002038 ZonMw Geestkracht (OOG)|
|- Public Title||RCT of Cognitive therapy and Schematherapy for comorbid anxiety- and cluster C personality disorders.|
|- Scientific Title||Randomized Controlled Trial of the Effectiveness of the Combination of Cognitive Behavioral Therapy and Schema Therapy in Anxiety Disorders with a Comorbid Cluster C Personality Disorder.|
|- hypothesis||The objective of this project is to gain knowledge about the how and when of cognitive behavioral treatment (CBT) of Axis I anxiety disorders when there is co-morbidity of an Axis II cluster C personality disorder. |
It tries to answer the question whether a treatment of both Axis I and Axis II disorders is more effective than treatment of solely the Axis I or Axis II disorder.
|- Healt Condition(s) or Problem(s) studied||Anxiety, Personality disorder, Co-morbidity|
|- Inclusion criteria||Patients with an Axis I anxiety disorder (of panic disorder with/without agoraphobia, agoraphobia without a history of panic disorder, obsessive-compulsive disorder, social phobia, generalized anxiety disorder) as primary diagnosis, according to DSM-IV-TR.
If there is an Axis I anxiety disorder present as primary diagnosis, patients will be screened for a co-occurring cluster C personality disorder (dependent personality disorder, avoidant personality disorder, obsessive-compulsive personality disorder), using a self-report questionnaire, the ADP-4 as a screener (Scotte et al., 1998). When this screening list is positive for a Cluster C personality disorder, co-morbidity of an Axis II cluster C personality disorder will be formally established using the
corresponding part of the Structured Clinical Interview for DSM-IV Axis II Personality Disorders
Further inclusion criteria are as follows:
1. Patients have to be 18 years of age or older
2. Patients have to be fluent in the Dutch language
3. Treatment has to be voluntary
4. There has to be informed consent, both for the treatment itself and for participation in the research project.
|- Exclusion criteria||Exclusion criteria are as follows: |
1. Evidence of a mental retardation with an IQ less then 70
2. Signs of acute danger to self or others and/or (need for) involuntary treatment
3. A history of psychotic disorders
4. Patients already in therapy and receiving a psychological treatment for their anxiety or Cluster C personality disorder
5. Patients who have a cluster A or cluster B personality disorder
6. Patients who have a major depressive disorder
7. Patients with a specific phobia (because of relative ‘simplicity’ and short duration of treatment) or post-traumatic stress disorder (because of relative ‘complexity’ and overall long duration of treatment(8) patients who are incapable of filling in the different
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||31-dec-2013|
|- Target number of participants||180|
|- Interventions||In treating the Axis I anxiety disorder the recommendations of the Dutch guideline for Anxiety disorders will be followed. Treatment will consist of maximally 30 sessions of cognitive behavioral therapy. For the treatment of cluster c personality disorders a protocol of schema therapy will be used (maximally 30 sessions). Combined treatment will consist of treatment of anxiety disorders (15 sessions) followed by treatment of the cluster c personality disorder (15 sessions).|
|- Primary outcome||As primary outcome measure significant changes in general anxiety as assessed with the Beck Anxiety Inventory (BAI) (Beck & Steer, 1990) will be used.|
|- Secondary outcome||Secondary measures will assess:|
- more specific forms of anxiety (PSWQ, ASI, FQ, LSAS, PI-R)
- general psychopathology (SCL-90R)
- interpersonal problems (IIP, WAV)
- personality pathology (ADP-IV, NEO-PI-R, NVM)
- cognitive schemas and schema modes (SV-1, PDBQ, YPI, YRAI, YCI, SMI-R)
- quality of life (WHOQOL-Bref, EQ-6D)
- direct and indirect costs (TIC-P)
- patient satisfaction (GGZ-thermometer).
Remission from anxiety and AXIS II disorder is measured with the MINI and the SCID-II at post treatment and at follow up. Also an implicit computer task will be used to measure the decrease of personality pathology. To evaluate the efficacy of the treatment modalities a cost analysis will be performed using data from a medical consumption diary kept by the patient.
|- Timepoints||Multi-center randomized controlled clinical trial with repeated measurements at baseline (M0), midtreatment (M5) posttreatment (M10) and follow-up M(6) and M(12) after posttreatment.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. V.C. Braeckman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Spinhoven|
|- Sponsor/Initiator ||Leiden University; Pieter de la Court gebouw |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background: |
DSM-IV Cluster C personality disorders are the most prevalent personality disorders (Torgersen et al, 2001, Torgersen, 2005). This is also true for the Dutch general population (Sytema & Koopmans, 1998). The prevalence, according to the authors, ranges from 4.4 – 5.2 %. Research on the comorbidity of personality disorders and anxiety disorders suggests that a common personality pattern, with predominantly Cluster C personality disorders, is characteristic for all anxiety disorders (Van Velzen & Emmelkamp, 1999). In existing Dutch guidelines of the Werkgroep angststoornissen (2003) and the Werkgroep Persoonlijkheidsstoornissen (2007) it is stated that there is no research available for the treatment of the co-occurrence of Axis I and Axis II disorders and the subsequent treatment options.
Objective of the study is to study the effects of combined treatment of Axis I and Axis II Anxiety disorders compared to the treatment of only Axis I or Axis II disorder on the short and long term.
Multi-center randomized controlled clinical trial with repeated measurements at baseline (M0), midtreatment (M5) posttreatment (M10) and follow-up M(6) and M(12) after posttreatment.
The research study is aimed at adult patients with an anxiety disorder and a comorbid Cluster C personality disorder. The research sample will be recruited from the patients applying for treatment at the outpatient clinics of ADAPT (Dimence) in Deventer and Almelo, Angstpoli in Nijmegen (GGZ Nijmegen) and several of the outpatient branches of the HSK-Group in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||16-nov-2008 - 23-nov-2008|