CClinicalTrials.gg
Enrolling by invitationNCT05986552IST-IGSTUpdated May 6, 2026

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

An interventional study of Individual Schema Therapy (IST) and Individual-Group Schema Therapy (IGST) in Borderline Personality Disorder, sponsored by University of Amsterdam. Enrolling by invitation at 3 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Amsterdam · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Schema Therapy (ST) for Borderline Personality Disorder (BPD) was originally developed and tested as an individual treatment. Since 2009 group-ST became popular as an supposedly efficient alternative. A RCT found combined individual-group ST to be superior to predominantly group-ST. Thus, individual ST is important. The question arises how combined individual-group ST compares to purely individual ST. This study compares the two formats of ST in a multicenter randomized clinical trial (RCT). The primary outcomes are severity of BPD and (early) treatment dropout. Secondary outcomes include: measures of specific BPD-symptoms; schemas and schema-modes; general mental symptoms; general functioning; and happiness. Moderators hypothesized to predict what patient characteristics are related to differences in effectiveness between the 2 formats are also tested. At least 132 BPD patients from at least 2 sites will be randomized to combined individual-group ST or individual ST. Treatments will take 2 years. Assessments take place every 6 months, and 1 year after end of treatment.

02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Borderline Personality Disorder
  • Schema Therapy
  • Psychotherapy
  • Therapy format
  • Randomized Clinical Trial
03

In context

Borderline Personality Disorder

269 studies on the registry are indexed under Borderline Personality Disorder; 67 are open to participants now.

This study's planned enrollment of 132 is above the median of 70 across 215 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

University of Amsterdam is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.)
  • Not able or willing to plan participation in the treatment sessions. Note 1. In case of suspicion of exclusion criteria that need specific assessment, like IQ and dementia, a formal diagnostic assessment needs to be done before in/exclusion can be decided.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    Individual Schema Therapy (IST)

    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)

  • Active comparator
    Combined Individual-Group Schema Therapy (IGST)

    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

  • BehavioralIndividual Schema Therapy (IST)

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

  • BehavioralIndividual-Group Schema Therapy (IGST)

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0, 6,12,18, 24 and 36 months

  2. Early treatment dropout rate

    Rate of dropout from treatment within the first 6 months

    Time frame: 6 months

Secondary outcomes

  1. Severity of each of the 9 BPD criteria

    Severity of separate BPD criteria will be assessed with the subscales of the Borderline Personality Severity Index 5 (BPDSI-5). Each subscale has a range from 0 to 10, higher scores mean worse outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

  2. Suicidality

    Suicidality will be assessed by the pertinent criterion 5 items of the Borderline Personality Disorder Severity Index 5 (BPDSI-5). The range is 0-10, higher scores mean worse outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

  3. Number of suicide attempts

    Number of suicide attempts during the last 3 months will be assessed by item 5.13 of the Borderline Personality Disorder Severity Index 5 (BPDSI-5). The minimum is 0, the maximum is not defined. Higher scores mean worse outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

  4. Subjective burden of Borderline Personality Disorder

    The subjective burden of Borderline Personality Disorder will be assessed with the Borderline Personality Disorder Checklist (BPDCL). The range is 47-235, higher scores mean worse outcome.

    Time frame: 0, 6,12,18, 24 and 36 months

  5. General psychopathology symptoms

    General psychopathology symptoms will be assessed with the Brief Symptom Inventory (BSI). The range is 0-4, higher scores mean worse outcome.

    Time frame: 0, 6,12,18, 24 and 36 months

  6. General, social, and societal functioning

    General, social, and societal functioning will be assessed with the World Health Organization Disability Assessment Schedule (WHODAS), taken by the research assistant who is blind for condition. The minimum score is 0, the maximum 100. Higher scores mean worse outcome.

    Time frame: 0, 6,12,18, 24 and 36 months

  7. Happiness

    Happiness is assessed with the 1-item happiness question validated in more than 30 countries. Range is 1-7, higher scores mean better outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

  8. Early Maladaptive Schemas

    Early Maladaptive Schemas will be assessed with the Young Schema Questionnaire short form (YSQ-SF). The range is 90-540; higher scores mean worse outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

  9. Schema Modes

    Schema Modes will be assessed with the Schema Mode Inventory (SMI). The minimum of the dysfunctional mode score is 123, the maximum 738, with higher scores meaning worse outcomes. The minimum of the functional modes score is 20, the maximum 120, with higher scores meaning better outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

  10. Number of medications used

    Medication use will be monitored during treatment and at each assessment. The minimum number is zero; the maximum is not defined. Higher numbers mean worse outcomes.

    Time frame: 0, 6,12,18, 24 and 36 months

07

Study locations

3 sites
  • Academic Center for Trauma and Personality ACTP
    Amsterdam, 1001NK, Netherlands
  • Arkin Mental Health Care
    Amsterdam, 1093 MB, Netherlands
  • GGZ Oost-Brabant
    Helmond, Netherlands
08

References and documents

Publications

  • Arntz, A. & van Genderen, H. (2020). Schema Therapy for Borderline Personality Disorder, 2nd Edition. Chichester, UK: John Wiley & Sons.
  • 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. PubMed 36453183 ↗
  • 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. PubMed 35234828 ↗
  • 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
  • Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605. PubMed 6622612 ↗
  • 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.
  • 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.
  • 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. PubMed 20487590 ↗
  • 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.
  • Veenhoven R. World Database of Happiness. 2023. https://worlddatabaseofhappiness.eur.nl/.
  • 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

Individual participant data

Plan to share: No — Given Dutch and European Union legal data protection regulations sharing individual data with other researchers can only be considered if other researchers can guarantee meeting strict conditions.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05986552
Lead sponsor
University of Amsterdam
Collaborators
Academic Center for Trauma and Personality, Arkin Mental Health Care, Ggz Oost Brabant
Responsible party
Arnoud Arntz (Professor, University of Amsterdam) — Principal investigator
First posted
Aug 14, 2023
Start date
Nov 10, 2023
Primary completion
Aug 30, 2030 (estimated)
Completion
Aug 30, 2030 (estimated)
Last update
May 6, 2026

Study contacts

Arnoud Arntz, PhD
principal investigator · University of Amsterdam
Sophie Rameckers, MSc
principal investigator · University of Amsterdam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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