Borderline Personality Disorder
Conditions
Keywords
Borderline Personality Disorder, Schema Therapy, Psychotherapy, Therapy format, Randomized Clinical Trial
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.
Interventions
BEHAVIORALIndividual Schema Therapy (IST)
IST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in individual sessions by trained therapists.
BEHAVIORALIndividual-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.
Sponsors
University of Amsterdam
Academic Center for Trauma and Personality
Arkin Mental Health Care
Ggz Oost Brabant
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Assessors and investigator are blind to treatment arm up to and including the last follow-up assessment.
Intervention model description
Multicenter Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Borderline Personality Disorder Severity | 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. |
| Early treatment dropout rate | 6 months | Rate of dropout from treatment within the first 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of each of the 9 BPD criteria | 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. |
| Suicidality | 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. |
| Number of suicide attempts | 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. |
| Subjective burden of Borderline Personality Disorder | 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. |
| General psychopathology symptoms | 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. |
| General, social, and societal functioning | 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. |
| Happiness | 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. |
| Early Maladaptive Schemas | 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. |
| Schema Modes | 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. |
| Number of medications used | 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. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORArnoud Arntz, PhD
University of Amsterdam
PRINCIPAL_INVESTIGATORSophie Rameckers, MSc
University of Amsterdam
Outcome results
None listed