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A multi-site randomized controlled trial comparing Schema Therapy and Dialectical Behavior Therapy 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 Dialectical Behavior Therapy 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-OMON49443
Enrollment
200
Registered
2018-11-20
Start date
2019-02-17
Completion date
Unknown
Last updated
2026-05-18

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. Dialectical Behavior Therapy (DBT) 2. Schema Therapy (ST) There are two different intervention conditions, DBT or ST, which participants are randomly assigned to. Both treatments will consist of

Sponsors

Universiteit van Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Primary diagnosis of BPD 2. Age 18-65 years 3. Borderline Personality Disorder Severity Index, fifth edition (BPDSI-5) score above 20 4. Dutch literacy 5. The willingness and ability to participate in (group) treatment for a maximum of 24 months and to complete the assessments over a period of three years

Exclusion criteria

Exclusion criteria: 1. Psychotic disorder in the past year (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 with at least one manic episode in the past year 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-5, 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-5 (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-5 (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) and the Mental Health Quality of Life seven-dimensional Questionnaire (MHQoL-7D; van Krugten et al., 2019). - 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). - A subgroup of patients (N=30) will receive two additional questionnaires, including the Y

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026