Clinical trial NCT05986552: The Influence of Treatment Format on Schema Therapy for Borderline Personality Disorder
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Schema Therapy
Psychotherapy
Therapy format
Randomized Clinical Trial
Lead sponsor: University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Academic Center for Trauma and Personality
name: Arkin Mental Health Care
First posted: 2023-08-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter Randomized Clinical Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Borderline Personality Disorder Severity
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Early treatment dropout rate
timeFrame: 6 months
Secondary outcomes:
measure: Severity of each of the 9 BPD criteria
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Suicidality
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Number of suicide attempts
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Subjective burden of Borderline Personality Disorder
timeFrame: 0, 6,12,18, 24 and 36 months
measure: General psychopathology symptoms
timeFrame: 0, 6,12,18, 24 and 36 months
measure: General, social, and societal functioning
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Happiness
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Early Maladaptive Schemas
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Schema Modes
timeFrame: 0, 6,12,18, 24 and 36 months
measure: Number of medications used
timeFrame: 0, 6,12,18, 24 and 36 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Center for Trauma and Personality ACTP
city: Amsterdam
country: Netherlands
facility: Arkin Mental Health Care
Study officials:
affiliation: University of Amsterdam
name: Arnoud Arntz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam
name: Sophie Rameckers, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arntz, A. & van Genderen, H. (2020). Schema Therapy for Borderline Personality Disorder, 2nd Edition. Chichester, UK: John Wiley & Sons.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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