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A multi-site randomized controlled trial comparing Schema Therapy and Mentalization-Based Treatment for borderline personality disorder: A framework for the study of (differential) change processes and the empirical search for treatment selection criteria.

A multi-site randomized controlled trial comparing Schema Therapy and Mentalization-Based Treatment for borderline personality disorder: A framework for the study of (differential) change processes and the empirical search for treatment selection criteria.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21791
Enrollment
200
Registered
2016-02-22
Start date
2016-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The present study focuses on the treatment of patients with borderline personality disorder (BPD). BPD is a complex and severe mental disorder, characterized by a pervasive pattern of instability in emotion regulation, self-image, interpersonal relationships, and impulse control (APA, 1994

Interventions

Mentalization-Based Treatment (MBT): MBT is a psychodynamic-oriented treatment that focuses on increasing mentalization in borderline patients. Mentalization refers to the process of implicitly and e
Bateman & Fonagy, 2010). Bateman and Fonagy (2010) defined the unstable capacity for mentalization as the core feature of BPD. The mentalizing capacity of patients with BPD typically fails in the cont

Sponsors

University of Amsterdam, Department of Clinical Psychology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary diagnosis of BPD 2. Borderline Personality Disorder Severity Index, fourth edition (BPDSI-IV) score above 20 3. Dutch literacy 4. The willingness and ability to participate in (group) treatment for at least 24 months

Exclusion criteria

Exclusion criteria: 1. Psychotic disorder (except short reactive psychotic episodes, see BPD criterion 9 of the DSM 5) 2. Severe addiction requiring clinical detoxification (after which entering is possible) 3. Bipolar I disorder (except when in full remission) 4. IQ < 80 5. Travel time to the MBT or ST setting longer than 45 minutes (except when the participant lives in the same city) 6. No fixed home address 7. Have received ST or MBT in the previous year 8. Antisocial personality disorder with a history of physical interpersonal violence (in the last two years)

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is change in the severity and frequency of the DSM-IV BPD manifestations (BPDSI-IV, total score; Arntz et al., 2003; Giesen-Bloo, Wachters, Schouten, & Arntz, 2010).

Secondary

MeasureTime frame
• DSM-IV diagnostic status, assessed by the Structured Clinical Interviews for the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) Axis I disorders (SCID I; Van Groenestijn, Akkerhuis, Kupka, Schneider, & Nolen, 1998) and Axis II disorders (SCID II; Weertman, Arntz, & Kerkhofs, 2000); • BPDSI-IV (Arntz et al., 2003; Giesen-Bloo et al., 2010) reliable change and recovery (i.e., score below 15); • Dimensional scores for each of the DSM-5 BPD-criteria as assessed with the BPDSI-IV (Arntz et al., 2003; Giesen-Bloo et al., 2006); • Quality of life, assessed using the EuroQol EQ-5D-3L (Rabin & Charro, 2001); • General functioning, including work/study and societal participation, assessed by the WHO Disability Assessment Schedule (WHODAS 2.0; Üstün, Kostanjsek, Chatterji, & Rehm, 2010); • General psychopathology as measured with the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983); • Happiness, measured with a single question on general happiness (Veenhoven, 2008); • Sleep, measured using the Insomnia Sleep Index (Bastien, Vallières, & Morin, 2001) and two items measuring nightmare frequency; • Costs, including healthcare, patient and family costs and costs outside the health care sector, measured using a retrospective cost interview especially designed for BPD patients (Wetzelaer et al., 2014).

Contacts

Public ContactC.J.M. Wibbelink

University of Amsterdam

C.J.M.Wibbelink@UvA.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)