|- candidate number||8183|
|- NTR Number||NTR2392|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jun-2010|
|- Secondary IDs||NL28016.068.09 / MEC 09-3-044 ; CCMO / medical ethical committee azM/UM|
|- Public Title||Group Schema Therapy for Borderline Personality Disorder.|
|- Scientific Title||Multi-Site RCT of Group Schema Therapy for Borderline Personality Disorder.|
|- hypothesis||Group Schema Therapy is more effective and more cost-effective than treatment as usual for Borderline Personality Disorder.
Two subforms of group Schema Therapy (with different ratio of group and individual sessions) will also be compared, and stakeholders' opinions will be investigated (patients, therapists).
|- Healt Condition(s) or Problem(s) studied||Borderline personality disorder |
|- Inclusion criteria||1. Age 18-65 year;|
2. Primary DSM-IV diagnosis of BPD (assessed with the SCID-II interview);
3. BPD severity above 20 on the BPDSI interview;
4. Willingness to participate in the study (informed consent procedure);
5. Ability to participate in (group) treatment and research for 2 years (e.g., no plans to move to other city).
|- Exclusion criteria||1. Lifetime psychotic disorder (short stress-related episodes are allowed, as described in DSM-IV BPD criterion 9);|
2. IQ < 80 (in case of suspicion of low IQ, to be assessed with full intelligence test);
3. Unable to read, speak, or write the language used at the site (in case of suspicion an official language test is to
4. ADHD (when suspected on basis of self-report for the KID-SCID is used to assess ADHD);
5. Bipolar disorder type 1 (SCID-1);
6. Dissociative Identity Disorder (confirmed by senior investigators);
7. Full or sub-threshold (defined as one less than the number of criteria to qualify for the diagnosis ) narcissistic or antisocial personality disorder (SCID-2);
8. Substance dependence needing clinical detox (after detox and 2 months sobriety can be included);
9. Serious and/or unstable medical illness;
10. Previous schema therapy of more than 3 months duration.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2010|
|- planned closingdate||1-feb-2016|
|- Target number of participants||448|
|- Interventions||Experimental A: 118 group Schema Therapy sessions over 2 years with max. 17 individual sessions.
Experimental B: 64 group Schema Therapy over 2 years with max. 61 individual sessions.
Control: Treatment as usual - the standard treatment given for that patient at the treatment center.
|- Primary outcome||Borderline Personality Disorder Severity Index, mean score.|
|- Secondary outcome||1. BPD-checklist, BSI, GAF, Work;|
2. Social Adjustment Scale, Social Occupational Functioning Assessment Scale, Social Adjustment Scale-Self Report;
3. WHOQOL, EuroQol, Happiness Rating;
4. Schema questionnaire, Schema Mode Inventory, Group Climate Questionnaire (GCQ-S).
|- Timepoints||Baseline, 6,12,18, 24 months and 36 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Arnoud Arntz|
|- CONTACT for SCIENTIFIC QUERIES|| Arnoud Arntz|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Dutch National Fund of Mental Health, Else-Kröner Fresenius Stiftung (Germany).|
|- Brief summary||In an international multicenter RCT two forms of group Schema Therapy for Borderline Personality Disorder will be compared to the usual treatment provided to these patients. Effectiveness, cost-effectivenss (with full economic analysis, incl cost-utility and cost-effectiveness), and stakeholders'opnions will be assessed. A secondary aim is to find out what format of group Schema Therapy is to be preferred: mainly group treatment, or the combination of group and individual treatment. the study will take place in at least 14 centers in the Netherlands, Germany, USA, UK, Sweden, Ireland and Australia. At each center min. 32 participants will be recruited, and randomized over the two forms of group Schema Therapy and treatment as usual. Experimental treatment will be provided for 2 years, and a last follow-up assessment will be done at year 3.|
|- Main changes (audit trail)|
|- RECORD||25-jun-2010 - 11-jul-2010|