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Borderline Personality DisorderIST-IGSTNCT05986552

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

A study testing Individual Schema Therapy (IST) and Individual-Group Schema Therapy (IGST) in people with Borderline Personality Disorder, run by University of Amsterdam at 3 sites in Netherlands.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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?… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Borderline Personality Disorder
What is being tested?
Individual Schema Therapy (IST) and Individual-Group Schema Therapy (IGST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
3 sitesNetherlands
Study dates
10 Nov 2023to 30 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands3 sites

  • Academic Center for Trauma and Personality ACTP

    Amsterdam, 1001NK

  • Arkin Mental Health Care

    Amsterdam, 1093 MB

  • GGZ Oost-Brabant

    Helmond

Other trials in Netherlands

About this study

Official title: The Influence of Treatment Format on Effectiveness of and Dropout From Schema Therapy for Borderline Personality Disorder: Individual vs. Combined Individual Group Schema Therapy

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.

Being tested
Individual Schema Therapy (IST), Individual-Group Schema Therapy (IGST)
Keywords
Borderline Personality Disorder, Schema Therapy, Psychotherapy, Therapy format, Randomized Clinical Trial
Medical subject headings
Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individual Schema Therapy (IST)Behavioural

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

  • Individual-Group Schema Therapy (IGST)Behavioural

    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.

Study groups in NCT05986552
Study groupRoleWhat they receive
Individual Schema Therapy (IST)Active comparatorIST 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.
Receives: Behavioral: Individual Schema Therapy (IST)
Combined Individual-Group Schema Therapy (IGST)Active comparatorIn 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.
Receives: Behavioral: Individual-Group Schema Therapy (IGST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

  2. Early treatment dropout rate

    Rate of dropout from treatment within the first 6 months

    Measured: 6 months

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start10 Nov 2023
  3. Primary completion30 Aug 2030 (estimated)
  4. Study completion30 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter Randomized Clinical Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986552
Sponsor's protocol ID
FMG-4449-2023
Acronym
IST-IGST
Status last verified
Apr 2026
First submitted
3 Aug 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Individual Schema Therapy (IST) and Individual-Group Schema Therapy (IGST) in people with Borderline Personality Disorder, run by University of Amsterdam at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Borderline Personality Disorder Severity (time frame: 0, 6,12,18, 24 and 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986552, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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