F60.31
Conditions
Interventions
Group 1: Standard DBT (face-to-face)
Standard DBT (S-DBT) is divided into different stages that are passed through during therapy. In Stage I, crisis-generating behaviors are primarily addressed. In S
Consultation Team. A published version of the treatment manual can be found in Linehan (2014).
In Arm 1, both group and individual therapy are presented face-to-face. Therapy lasts one year with wee
Sponsors
Zentralinstitut für Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Must be between 18 and 65 years of age 2) At least 5 of 9 DSM-5-defined criteria for BPD in the last 6 months and a BSL-23 score > 1.1 3) Agree to participate in weekly in-person or virtual treatment sessions for 12 months (with ability to travel to treatment centre with = 1h public transport) 4) Indicate they are available for at least one group group session time slots per treatment arm 5) Sufficient language skills in German or English 6) Stated willingness to comply with study procedures 7) Must be deemed to have capacity to provide informed consent and must provide written consent
Exclusion criteria
Exclusion criteria: 1) Lifetime diagnosis of schizophrenia or schizophreniform disorder, schizoaffective disorder. 2) Lifetime diagnosis of bipolar I disorder 3) Severe psychopathology requiring immediate treatment in another setting (such as acute alcohol dependence or acute alcohol withdrawal syndrome, BMI < 17.5 or dementia) 4) Mental retardation (IQ < 85) 5) =8 weeks of DBT in the last year (structured DBT program with all components).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Borderline Symptom List - Interview (BSL-I): is a clinical interview to assess the severity and change of BPD symptoms. The interview was developed based on the BSL-23 questionnaire. The BSL-23 is the most widely used self-report questionnaire instrument to assess borderline symptomatology and has been translated into 18 languages. Symptoms will be assessed on a 5-point scale ranging from 0 (no symptoms) to 4 (severe symptoms). The interview is completed online every three months during treatment and every six months during follow-up. Data Analysis: Analyses of treatment efficacy will be conducted by modeling the primary outcome measure using hierarchical linear models (HLM). To compare the effectiveness of the two groups, the interaction between treatment condition (TF-DBT vs. S-DBT) or treatment format (online vs. face-to-face) and time tested for significance. Standardized mean differences (Cohen's d) in TF-DBT pre and post therapy and between groups (TF-DBT vs. S-DBT) after therapy will be calculated to estimate effect sizes. The main analyses will be performed for all patients who fully complete therapy (According to Protocol, see 6.9 Dropout Policy in the study protocol for definition). In addition, the main analyses include the analysis of the intent-to-treat sample (ITT), which includes all patients who were included in the study by randomization to treatment (randomized is analyzed). Data will be analyzed after completion of the study. No interim analyses will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostics & Baseline 1 (cross-sectional data): Interviews: BPD Diagnosis (International Personality Disorder Examination; IPDE - BPD Section); Comorbidities (MINI International Neuropsychiatric Interview for DSM-V). Questionnaires: Traumatic Invalidation (Invalidating Childhood Environment Scale; ICES); Childhood trauma (Childhood trauma questionnaire; CTQ); Demographic Data (Demographic Data Schedule; DDS); Intelligence (Test of Premorbid Functioning (TOPF) in Canada or Mehrfachwahl Wortschatz Intelligenztest (MWT) in Germany); Dimensional Personality Facettes (Personality Inventory for DSM-5; PID-5); Unpredictability in Childhood (Questionnaire of Unpredictability in Childhood; QUIC); ADHD (Adult ADHD Self-Report Scale; ASRS); Bullying Experiences (Bullying Scale for Adults; BSA); Embitterness (Posttraumatic Embitterment Disorder Questionnaire; PTED; Berner Embitterness Scale; BEI) Longitudinal Assessment (Baseline, 3 months, 6 months, 9 months, 12 months [post]; 6 months follow-up, 12 months follow-up). Interviews: Suicidality (Columbia Suicide Severity Scale; SCSS); Psychosocial Functioning (Global Assessment of Functioning; GAF); Acute affective suicidality (Acute Suicidal Affective Disturbance Interview; ASAD-I). Questionnaires: Borderline Symptoms (Borderline Symptom List Questionnaire; BSL-23); Complex PTSD (International Trauma Questionaire; ITQ); Acute affective suicidality (Acute Suicidal Affective Disturbance Questionnaire; ASAD-L); General Psychopathology (Symptom Checklist 27; SCL-27+); Self-Harm (Deliberate Self-Harm Inventory; DSHI); Dissociation (Dissociative Symptom Scale; DSS); Loneliness (UCLA Loneliness Scale; UCLA)*; Social Connectedness (Social Connectedness Scale; SCS-R)*; Self-Esteem (Rosenberg Self-Esteem Scale; RSES)*; Personality Functioning in the alternative Personality Model (Level of Personality Functioning; LPFS-BF)*; Quality of Life (Recovering Quality of Life; ReQoL); Functioning (WHO Disability Assessment Schedule; WHODAS)* | — |
Countries
Canada, Germany
Contacts
Public ContactRuben Vonderlin
Zentralinstitut für Seelische Gesundheit
Outcome results
None listed