Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT) — REDBT  

Borderline Personality Disorder Clinical Trial

Official title: A Randomized Controlled Study of the Efficacy of an Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT) for a Population of Borderline Patients (Young Adults/Adults: 18 - 40), Compared With Standard Outpatient DBT.

Status Active, not recruiting

Clinical Trial Summary

An randomized clinical trial to investigate whether among adult borderline patients (18 - 40 year), intensified inpatient short term (12 weeks) inpatient Dialectical Behavior Therapy (DBT) is more effective in declining the proportion of patients that show suicidal/self-harming behavior in the first 3 months of treatment, compared to standard outpatient DBT, and whether this difference between the groups is sustained at 6 and 12 months.

Clinical Trial Description

Objective: Goal is to evaluate the (cost-)effectiveness of a short term intensive DBT treatment program (12 weeks) versus outpatient DBT, in terms of reduction of suicidal and/or self-harming behavior, and of general BPD symptomatology severity.

Study design: A randomized trial, analyzed by a intention-to-treat (ITT) approach, with two parallel groups: a) intensified adapted DBT program (12 weeks inpatient program, plus six months standard outpatient DBT, n=36); b) standard outpatient DBT for 12 months (n=36).

Study population: All borderline patients (18-40 years), who will be admitted from January 2013 till June 2014 for treatment in the Jelgersma Treatment Centre, or the outpatient DBT programs of Rivierduinen, who: (1) receive a diagnosis of BPD, (2) have shown suicidal and/or self-harming behavior in the year preceding the admission/ start of DBT treatment, including the last month preceding baseline measurement, and (3) show a severe level of borderline symptomatology (> 24 on the BPDSI).

Intervention:

All patients receive DBT according to the basic DBT treatment protocol. Treatment integrity is established by supervision in both groups.

Outcome measures Main study parameter is the number of suicide attempts/self-harming acts (the Life Time Parasuicide Count and the Parasuicide Scale of the Borderline Personality Severity Index). Second study parameter is the severity of borderline symptomatology (BPDSI). Quality of life as measured on the SF-36, and the EQ-5D and psychopathological symptoms (BSI) will also be taken into account. The cost-effectiveness of the inpatient program compared to the outpatient program will be examined (TiC-P).

Sample size. The researchers expect that after 12 weeks of treatment, 20% of the patients of the intervention group still show suicidal and/or self-harming behavior compared to 60% of the patients in the control condition, and that this difference sustains after 24 weeks and will be gradually reduced between 24 and 52 weeks by the additional reduction in suicidal and/or self-harming behavior in the control group. To be able to detect a difference of 40% after 12 weeks, with a power of 0.80 and α = 0.05, 36 patients per experimental condition are required. The researchers expect to recruit about 150 patients, which guarantees enough power, even with a 20% drop out rate. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

• NCT number: NCT01904227
• Study type: Interventional
• Source: Rivierduinen, Centre for Personality disorders Jelgersma
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2012
• Completion date: April 2015