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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Individual Schema Therapy (IST)
  IST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in individual sessions by trained therapists.
• Поведенческое Individual-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.

Первичные конечные точки

• Borderline Personality Disorder Severity [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Early treatment dropout rate [Срок оценки: 6 months]

Вторичные конечные точки (10)

• Severity of each of the 9 BPD criteria [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Suicidality [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Number of suicide attempts [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Subjective burden of Borderline Personality Disorder [Срок оценки: 0, 6,12,18, 24 and 36 months]
• General psychopathology symptoms [Срок оценки: 0, 6,12,18, 24 and 36 months]
• General, social, and societal functioning [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Happiness [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Early Maladaptive Schemas [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Schema Modes [Срок оценки: 0, 6,12,18, 24 and 36 months]
• Number of medications used [Срок оценки: 0, 6,12,18, 24 and 36 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 3 центра

• Academic Center for Trauma and Personality ACTP — Amsterdam
• Arkin Mental Health Care — Amsterdam
• GGZ Oost-Brabant — Helmond

Публикации

• 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. PMID 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/jamapsychia PMID 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. PMID 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. PMID 20487590

Идентификаторы

NCT: NCT05986552 · FMG-4449-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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