The Influence of Treatment Format on Schema Therapy for Borderline Personality Disorder

NCT05986552 | Enrolling By Invitation

• 1 other identifier: FMG-4449-2023
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to compare etc. in patients with borderline personality disorder pure individual schema therapy to combined individual-group schema therapy. The main questions it aims to answer are:

• is there a difference in effectiveness?
• is there a difference in (early) treatment dropout? Participants will receive either
• individual schema therapy or
• combined individual-group schema therapy. Researchers will compare individual to combined individual-group schema therapy see if there is a difference in effects and/or a difference in dropout from treatment.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; Schema Therapy; Psychotherapy; Therapy format; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Borderline Personality Disorder Severity

  The severity of manifestations of Borderline Personality Disorder during the last 3 months, assessed with a semi-structured clinical interview, the Borderline Personality Disorder Severity Index 5 (BPDSI-5), by an independent trained rater, blind for treatment arm. Minimum score is 0; maximum is 90; higher scores mean worse outcome.

  0, 6,12,18, 24 and 36 months

• Early treatment dropout rate

  Rate of dropout from treatment within the first 6 months

  6 months

Secondary Outcomes (10)

• Severity of each of the 9 BPD criteria

  0, 6,12,18, 24 and 36 months

• Suicidality

  0, 6,12,18, 24 and 36 months

• Number of suicide attempts

  0, 6,12,18, 24 and 36 months

• Subjective burden of Borderline Personality Disorder

  0, 6,12,18, 24 and 36 months

• General psychopathology symptoms

  0, 6,12,18, 24 and 36 months

Study Arms (2)

Individual Schema Therapy (IST)

ACTIVE COMPARATOR

IST will follow the revised protocol described by Arntz \& van Genderen. In the first year, 2 sessions (of 50-60 minutes each) per week will be provided, with at least one day in between. In the second year, the frequency will be reduced to once a week for the first 6 months, for the next 3 months to once every two weeks, and for the last 3 months three (booster) sessions will be offered. Therapists need to be trained at least at the junior level of the Dutch ST Association, or of the International ST society (ISST), or having successfully completed the basic IST training and delivering the trial treatments under supervision of a recognized ST supervisor.

Behavioral: Individual Schema Therapy (IST)

Combined Individual-Group Schema Therapy (IGST)

ACTIVE COMPARATOR

In IGST individual sessions (45-60 min) are provided weekly in the first year, and once every 2 weeks in the first three quarters of the second year, after which 3 monthly booster sessions are offered. Group sessions take place once per week for 1.5 years. After 1.5 years, patients leave the group but continue with IST during the last .5 year. If slots are available, new patients can enter the ST group every 10 weeks. GST is provided as semi-closed group format developed from the closed format as developed by Farrell \& Shaw. IST is based on Arntz \& van Genderen, with the addition that IST and GST are coordinated at weekly peer supervision meetings, and that problems related to the patient's participation in the group are put on the IST agenda. GST therapists don't need to be IST therapist of their patients. The same training requirements hold as in the IST arm. Additionally, GST-therapists completed GST training and receive(d) at least 10 GST supervisions.

Behavioral: Individual-Group Schema Therapy (IGST)

Interventions

Individual Schema Therapy (IST) BEHAVIORAL

IST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in individual sessions by trained therapists.

Individual Schema Therapy (IST)

Individual-Group Schema Therapy (IGST) BEHAVIORAL

IGST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in the combination of individual sessions and group therapy sessions by trained therapists.

Combined Individual-Group Schema Therapy (IGST)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BPD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), assessed with the Structured Clinical Interview for the DSM-5 Personality Disorders (SCID-5-PD), as primary diagnosis
• BPDSI total score ≥ 20 (i.e, severity in the BPD range, Giesen-Bloo et al., 2010)
• Ability to understand, read, write and speak Dutch, or English if the site has research assistants and therapists of both conditions that are sufficiently fluent in English, as well as an English ST group (as at ACTP).

You may not qualify if:

• DSM-5 substance use disorder that needs clinical detox according to the clinical staff (after 6 weeks of abstinence participation is possible).
• Comorbid psychotic disorder (patients with temporary psychotic problems falling under BPD criterion 9 are not excluded)
• DSM-5 Bipolar disorder, type 1 (current or past)
• Acute suicide risk
• Intelligence Quotient (IQ) \< 80
• Serious neurological problems such as dementia
• Patients should not start with any form of psychological treatment during screening or during the study's waitlist or treatment. (Low frequency supportive treatment may be continued during wait and screening, but not during the study treatment.)
• Note 2. No other psychological treatment during the study follow-up period is provided, unless this is necessary (clinical judgment). The 1 year treatment-free follow-up period is part of the treatment protocol, to help patients gain experience with life without mental health care. After 1 year further treatment can be offered, if indicated.

Sponsors & Collaborators

• Ggz Oost Brabant: collaborator
• University of Amsterdam: lead
• Academic Center for Trauma and Personality: collaborator
• Arkin Mental Health Care: collaborator

Study Sites (3)

Academic Center for Trauma and Personality ACTP

Amsterdam, 1001NK, Netherlands

Location

Arkin Mental Health Care

Amsterdam, 1093 MB, Netherlands

Location

GGZ Oost-Brabant

Helmond, Netherlands

Location

Related Publications (11)

• Arntz, A. & van Genderen, H. (2020). Schema Therapy for Borderline Personality Disorder, 2nd Edition. Chichester, UK: John Wiley & Sons.

  BACKGROUND

• Arntz A, Mensink K, Cox WR, Verhoef REJ, van Emmerik AAP, Rameckers SA, Badenbach T, Grasman RPPP. Dropout from psychological treatment for borderline personality disorder: a multilevel survival meta-analysis. Psychol Med. 2023 Feb;53(3):668-686. doi: 10.1017/S0033291722003634. Epub 2022 Dec 1.

  PMID: 36453183 BACKGROUND

• Arntz A, Jacob GA, Lee CW, Brand-de Wilde OM, Fassbinder E, Harper RP, Lavender A, Lockwood G, Malogiannis IA, Ruths FA, Schweiger U, Shaw IA, Zarbock G, Farrell JM. Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Apr 1;79(4):287-299. doi: 10.1001/jamapsychiatry.2022.0010.

  PMID: 35234828 BACKGROUND

• Bloo J, Arntz A, Schouten E. The Borderline Personality Disorder Checklist: Psychometric evaluation and factorial structure in clinical and nonclinical samples. Roczniki Psychologiczne // Annals of Psychology. 2017; 20(2): 281-336. http://dx.doi.org/10.18290/rpsych.2017.20.2-3en

  BACKGROUND

• Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

  PMID: 6622612 BACKGROUND

• Farrell, J.M. & Shaw, I.A. (2012). Group schema therapy for borderline personality disorder: A step-by-step treatment manual with patient workbook. Hoboken: Wiley.

  BACKGROUND

• Giesen-Bloo JH, Wachters, LM, Schouten E, Arntz A. The Borderline Personality Disorder Severity Index-IV: Psychometric evaluation and dimensional structure. Personality and Individual Differences. 2010; 49: 136-141.

  BACKGROUND

• Lobbestael J, van Vreeswijk M, Spinhoven P, Schouten E, Arntz A. Reliability and validity of the short Schema Mode Inventory (SMI). Behav Cogn Psychother. 2010 Jul;38(4):437-58. doi: 10.1017/S1352465810000226. Epub 2010 May 21.

  PMID: 20487590 BACKGROUND

• Üstün TB, Kostanjsek, N, Chatterji, S, Rehm, J. Measuring health and disability: manual for WHO disability assessment schedule WHODAS 2.0. Geneva: World Health Organization, 2010.

  BACKGROUND

• Veenhoven R. World Database of Happiness. 2023. https://worlddatabaseofhappiness.eur.nl/.

  BACKGROUND

• Young JE, Brown, G. Young Schema Questionnaire-Short Form; Version 3 (YSQ-S3, YSQ) [Database record]. APA PsycTests, 2005. https://doi.org/10.1037/t67023-000

  BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Arnoud Arntz, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Sophie Rameckers, MSc

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors and investigator are blind to treatment arm up to and including the last follow-up assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicenter Randomized Clinical Trial

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)