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| Name | Class |
|---|---|
| Academic Center for Trauma and Personality | UNKNOWN |
| Arkin Mental Health Care | UNKNOWN |
| Ggz Oost Brabant | OTHER |
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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:
Participants will receive either
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 6,12,18, 24 and 36 months |
| Suicidality |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Arnoud Arntz, PhD | University of Amsterdam | Principal Investigator |
| Sophie Rameckers, MSc | University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Center for Trauma and Personality ACTP | Amsterdam | 1001NK | Netherlands | |||
| Arkin Mental Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Arntz, A. & van Genderen, H. (2020). Schema Therapy for Borderline Personality Disorder, 2nd Edition. Chichester, UK: John Wiley & Sons. | ||
| 36453183 | 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. | |
| 35234828 |
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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.
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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Multicenter Randomized Clinical Trial
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Assessors and investigator are blind to treatment arm up to and including the last follow-up assessment.
| 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. |
|
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. |
| 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| 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. | 0, 6,12,18, 24 and 36 months |
| Amsterdam |
| 1093 MB |
| Netherlands |
| GGZ Oost-Brabant | Helmond | Netherlands |
| 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. |
| 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 |
| 6622612 | Background | Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605. |
| 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. |
| 20487590 | 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. |
| 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 |