|- candidate number||24550|
|- NTR Number||NTR5957|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jul-2016|
|- Secondary IDs||P12.227 METC|
|- Public Title||Mentalization-Based Treatment with and without Competitive Memory Training for patients with Borderline Personality Disorder: randomized controlled trial|
|- Scientific Title||Mentalization-Based Treatment with and without Competitive Memory Training for patients with Borderline Personality Disorder: randomized controlled trial|
|- hypothesis||A. COMET as an additional transdiagnostic intervention focusing specifically on low self-esteem increases the effectiveness of mentalization based treatment in patients diagnosed with borderline personality disorder. B. This increased effectiveness is mediated by changes in self-esteem. C. MBT results in changes in attachment and these changes predict a more favourable course of the disorder.|
|- Healt Condition(s) or Problem(s) studied||Borderline personality disorder |
|- Inclusion criteria||1. Patients are registered with the Rivierduinen care program ‘Personality Disorders’. |
2. Aged between 18 and 65 years.
3. Confirmation of the primary diagnosis of borderline personality disorder using the International Personality Disorder Examination (IPDE) for DSM-IV.
4. BPDSI-IV score ≥ 20.
5. Informed consent.
|- Exclusion criteria||1. Insufficient command of the Dutch language to participate in group treatment and to fully understand the questionnaires and treatment handouts.|
2. Severe comorbid psychopathology such as: psychotic disorders (except short, reactive psychotic episodes, that can be part of the clinical picture of BPD), bipolar disorder, dissociative identity disorder, antisocial personality disorder, attention deficit hyperactivity disorder, addiction of such severity that clinical detoxification is indicated (after which entering treatment is possible), psychiatric disorders secondary to medical conditions and mental retardation. Comorbid axis 1 and axis 2 disorders are allowed, as is medication use.
3. Simultaneous participation in another specific psychiatric treatment, except medication.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2014|
|- planned closingdate||1-dec-2018|
|- Target number of participants||78|
|- Interventions||MBT(Mentalization Based Treatment) + COMET (Competitive Memory Training; intervention specifically targeting low self-esteem)|
Control: MBT (Mentalization Based Treatment) + Music therapy
|- Primary outcome||BPDSI score (Borderline Personality Disorder Severity Index)|
|- Secondary outcome||Depression (BDI-II score: Beck Depression Inventory)
Psychiatric symptoms (BSI score: Brief Symptom Inverntory)
Interpersonal problems (IPP-S score: Inventory of Interpersonal Problems-Short Form)|
Self esteem problems (RSES score: Rosenberg Self Esteem Scale)
Self esteem instability (SEIS score: The Self-Esteem Instability Scale)
Implicit Self esteem (IAT score: Implicit Association Test Self-esteem)
Attachment (ECR-R score: Experiences in Close Relationships-Revised)
TAT score (Thematic Apperception Test)
|- Timepoints||Patients are evaluated at the start of treatment (baseline), at 5 months post-baseline, after finishing therapy (at 12 months post-baseline), and at follow-up (24 months post baseline).|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. B. van Klaveren|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Spinhoven|
|- Sponsor/Initiator ||GGZ Rivierduinen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Low self-esteem is one of the core symptoms in patients with borderline personality disorder. In the proposed study we investigate whether an additional transdiagnostic intervention that specifically targets low self-esteem (COMET) will make the general evidence-based treatment, Mentalization-Based Therapy (MBT), for borderline personality disorder patients more effective, and whether such enhanced effectiveness is mediated by changes in self-esteem. Moreover, the predictive value of changes in attachment during treatment for the course of the disorder will be assessed. |
The effectiveness of the MBT plus COMET will be investigated by comparing this combined intervention with a control condition (MBT plus Music Therapy) in a randomized controlled design. A total of 78 patients with BPD as diagnosed with the International Personality Disorder Examination interview (IPDE) in the age of 18-65 years old will be enrolled. Patients will receive weekly MBT group sessions for one year, combined with 8 weeks of either music therapy or COMET. Primary outcome measure will be the Borderline Personality Disorder Severity Index (BPDSI) interview. Moreover, putative mediators (i.e. self-esteem and attachment) will be measured. Assessments will take place at baseline, after completing COMET or music therapy (after 5 months), at the end of treatment (after 12 months) and at follow-up (after 24 months). The trial will increase our knowledge on the value of specifically targeting self-esteem in borderline personality disorder.
|- Main changes (audit trail)|
|- RECORD||3-jul-2016 - 28-aug-2016|