Clinical trial NCT01904227: Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT)
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Dialectical Behavior Therapy
Lead sponsor: GGZ Rivierduinen
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2013-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients admitted in the period of January 2013 until January 2014
* patients who fulfill the Diagnostic and Statistical Manual-IV Text Revision criteria for BPD,
* patients who 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,
* patients who show a severe level of borderline symptomatology ( \> 24 on the BPDSI),
* patients who are in sufficient command of the Dutch language

Exclusion Criteria::

* Intelligence Quotient \< 80,
* a chronic psychotic condition,
* bipolar disorder,
* hard drug abuse that requires inpatient detoxification,
* forced treatment framework,
* DBT in the year preceding intake.

Primary outcomes:
measure: assessing change in number of suicide attempts/self-harming acts
timeFrame: baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Secondary outcomes:
measure: assessing change in the severity of borderline symptomatology
timeFrame: at baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Other outcomes:
measure: assessing change in level of Quality of life
timeFrame: baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
measure: assessing the cost-effectiveness of the inpatient program compared to the outpatient program
timeFrame: baseline and 52 weeks after the start of the inpatient treatment
measure: assessing change in level of psychopathological symptoms
timeFrame: baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Locations:
city: Oegstgeest
country: Netherlands
facility: LMC van den Bosch
Study officials:
affiliation: GGZ Rivierduinen
name: Louisa M van den Bosch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Sinnaeve R, van den Bosch LMC, Hakkaart-van Roijen L, Vansteelandt K. Effectiveness of step-down versus outpatient dialectical behaviour therapy for patients with severe levels of borderline personality disorder: a pragmatic randomized controlled trial. Borderline Personal Disord Emot Dysregul. 2018 Jul 10;5:12. doi: 10.1186/s40479-018-0089-5. eCollection 2018.