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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. - BOOTS: Borderline Optimal Treatment Selection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46272
Enrollment
200
Registered
2017-06-23
Start date
2017-11-29
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

Borderline personality disorder personality problems

Interventions

1. Mentalization-Based Treatment (MBT) 2. Schema Therapy (ST) There are two different intervention conditions, MBT or ST, which participants are randomly assigned to. Both treatments will consist of
Borderline personality disorder

Sponsors

Universiteit van Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Primary diagnosis of BPD 2. Age 18-65 years 3. Borderline Personality Disorder Severity Index, fourth edition (BPDSI-IV) score above 20 4. Dutch literacy 5. 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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is change in the severity and frequency of the DSM-5 BPD manifestations (BPDSI-IV, total score; Arntz et al., 2003; Giesen-Bloo, Wachters, Schouten, & Arntz, 2010). This outcome measure is frequently used in other studies of ST: Giesen-Bloo et al. (2006), Van Asselt et al. (2008), Nadort et al. (2009), and Wetzelaer et al. (2014).

Secondary

MeasureTime frame
As accumulating evidence suggests that symptoms and level of functioning are only loosely associated, attention will be paid to outcome in terms of both symptom change and functioning, including relational, occupational, and personal (wellbeing) functioning. Therefore, the secondary outcome measures will include: * DSM-5 diagnostic status, assessed by the Structured Clinical Interviews for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Clinician Version (SCID-5-CV) and Personality Disorders (SCID-5-PD)*. * 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). * Psychopathology, personality characteristics, and behavioral proclivities, assessed by the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-rf; Ben-Porath & Tellegen, 2008). * 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). * Quality of life, assessed using the EuroQol EQ-5D-5L (Rabin & Charro, 2001). * 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, will be measured using a retrospective cost interview especially designed for BPD patients (Wetzelaer et al., 2014). Both treatments include non-specific (attachment and alliance) and specific (mentalization in MBT and schema modes in ST) mechanisms of change. Measures of the mechanisms of change will include:

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)