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Enrolling by Invitation

NCT Number: NCT05986552

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Center for Trauma and Personality ACTP, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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-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.

Primary outcomes

  1. Borderline Personality Disorder Severity

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

    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.

  2. Early treatment dropout rate

    Time frame: 6 months

    Rate of dropout from treatment within the first 6 months

Secondary outcomes

  1. Severity of each of the 9 BPD criteria

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

    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.

  2. Suicidality

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

    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.

  3. Number of suicide attempts

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

    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.

  4. Subjective burden of Borderline Personality Disorder

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

    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.

  5. General psychopathology symptoms

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

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

  6. General, social, and societal functioning

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

    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.

  7. Happiness

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

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

  8. Early Maladaptive Schemas

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

    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.

  9. Schema Modes

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

    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.

  10. Number of medications used

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

    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.

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Collaborators

  • Academic Center for Trauma and Personality
  • Arkin Mental Health Care
  • Ggz Oost Brabant

Registry information

Official study 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

Acronym: IST-IGST

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Aug 14, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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