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Dosage-trial Mentalisation-Based Treatment (MBT): Intensive Outpatient MBT versus Day Hospital MBT.


- candidate number7942
- NTR NumberNTR2292
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-apr-2010
- Secondary IDs2010-KP-1258 CE UvA afdeling Psychologie
- Public TitleDosage-trial Mentalisation-Based Treatment (MBT): Intensive Outpatient MBT versus Day Hospital MBT.
- Scientific TitleIntensive Outpatient Mentalisation-Based Treatment versus Day Hospital Mentalisation-Based Treatment: A randomised controlled trial.
- ACRONYM
- hypothesis1. Intensive Outpatient Mentalisation-Based Treatment (IOP-MBT) and Day Hospital Mentalisation-Based Treatment (DH-MBT) will both result in clinical improvement for patients with severe Personality Disorders (PDs);
2. Matching-hypothesis: the highest level of improvement is expected in DH-MBT, for patients with the highest level(s) of severity.
- Healt Condition(s) or Problem(s) studiedBorderline personality disorder , Personality disorder
- Inclusion criteria1. Referral to the MBT-program as implemented by De Viersprong, i.e. 18-month psychotherapy designed specifically for treatment refractory patients with complex personality disorders, often complicated by multi-morbidity, who have typically had a history of unsuccessful treatments;
2. At least one PD as diagnosed according to DSM-IV criteria.
- Exclusion criteriaPatients were only excluded if they met DSM-IV criteria for schizophrenia or intellectual impairment (IQ < 80). The WAIS was administered when intellectual impairment was suspected.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-feb-2010
- planned closingdate1-jul-2015
- Target number of participants80
- InterventionsThe MBT-program consists of a maximum of 18 months MBT, conducted conform the treatment manual (Bateman & Fonagy 2004, 2006), and continued by a maximum of 18 months of maintenance mentalizing (group) therapy. MBT aims to strenghten patients' capacity to understand their own and others' mental states in attachment contexts in order to address their difficulties with affect, impulse regulation, and interpersonal functioning, which act as triggers for acts of suicide and self-harm (Bateman & Fonagy, 2009).

MBT-DH: The day hospital program includes daily group psychotherapy, weekly individual psychotherapy, individual crisisplanning from a mentalizing perspective, art therapy twice a week, mentalizing cognitive therapy and writing therapy.

MBT-IOP: The outpatient MBT program consists of group psychotherapy twice a week, weekly individual psychotherapy, and individual crisisplanning from a mentalizing perspective.
- Primary outcome1. Frequency and severity of manifestations of (borderline) personality disorder (SCID-II, PAI-BOR);
2. Number of suicide acts (SSHI);
3. Number of self-mutilation acts (SSHI);
4. Subjective experience of symptoms (BSI);
5. Quality of life (EQ-5D);
6. Care consumption (TiC-P).
- Secondary outcome1. Axis I diagnosis (SCID-I);
2. Depression (BDI);
3. Interpersonal functioning (IIP);
4. Personality functioning (DAPP-SF);
5. Mentalisation (ECR, RFQ);
6. Treatment adherence.
- TimepointsBaseline measurements will be taken after randomisation and follow-up measurements will be conducted every 6 months after the baseline measurement (i.e. after 6, 12, 18, 24, 30, and 36 months).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD. Helene Andrea
- CONTACT for SCIENTIFIC QUERIESPhD. Helene Andrea
- Sponsor/Initiator Viersprong Institute for Studies on Personality Disorders (VISPD), Arkin Institute for Mental Health, University of Amsterdam (UvA), Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Viersprong Institute for Studies on Personality Disorders (VISPD)
- PublicationsN/A
- Brief summaryObjective:
To compare the treatment outcome and costs of Intensive Outpatient Mentalisation-Based (IOP-MBT) and Day Hospital MBT (DH-MBT).

Design:
A randomised controlled trial comparing IOP-MBT with DH-MBT. After the baseline measurement, patients will be followed up every 6 months for a total of 36 months.

Study population and data analysis:
1. Referral to the MBT-program as implemented by De Viersprong;
2. At least one PD as diagnosed according to DSM-IV criteria.
Analysis will be performed according to the intention to treat principle. In both treatment arms (IOP-MBT and DH-MBT) at least 40 patients will be included.

Intervention:
The MBT-program offers 18-month psychotherapy designed specifically for treatment refractory patients with complex personality disorders, often complicated by multi-morbidity, who have typically had a history of unsuccessful treatments. DH-MBT consists of daily group psychotherapy, weekly individual psychotherapy, individual crisisplanning from a mentalizing perspective, art therapy twice a week, and writing therapy. IOP-MBT consists of group psychotherapy twice a week, weekly individual psychotherapy, and individual crisisplanning from a mentalizing perspective.

Outcome measures:
The primary outcome measures refer to the frequency and severity of manifestions of (borderline) personality disorder, symptomatic functioning, quality of life, and care consumption. The secondary outcome measures include axis I diagnoses, interpersonal and personality functioning, mentalisation, and treatment adherence.
- Main changes (audit trail)
- RECORD16-apr-2010 - 11-apr-2011


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