Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT)

NCT01904227 | Unknown DMC

• 1 other identifier: Rivierduinen 2012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; Dialectical Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• assessing change in number of suicide attempts/self-harming acts

  The Lifetime Parasuicide Count (LPC: Comtois \& Linehan, 1999), obtains information about the frequency and subsequent medical treatment of self-mutilating behaviors (e.g. cutting, burning and pricking). Duration of the interview depends on how frequent and how much self-destructive behavior has been shown. Patients report that they feel that their problems are taken seriously because of the interview. The Borderline Personality Disorder Severity Index (BPDSI: (Giessen-Bloo et al., 2010) is a semi-structured interview assessing the frequency of borderline symptoms in the previous 3-month period. The BPDSI consists of nine sections, one for each of the Diagnostic and Statistical Manual-IV criteria for borderline personality disorder. The parasuicide section includes three items reflecting distinct suicidal behaviors (suicide threats, preparations for suicide attempts, and actual suicide attempts).

  baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment

Secondary Outcomes (1)

• assessing change in the severity of borderline symptomatology

  at baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment

Other Outcomes (3)

• assessing change in level of Quality of life

  baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment

• assessing the cost-effectiveness of the inpatient program compared to the outpatient program

  baseline and 52 weeks after the start of the inpatient treatment

• assessing change in level of psychopathological symptoms

  baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment

Study Arms (2)

Inpatient Adaptation of DBT

EXPERIMENTAL

Patients are in treatment 5 days a week, during 12 weeks. Staff is only present in daytime. During the weekends the patients stay at home. The therapy consists of DBT skills training (Linehan, 1996), individual psychotherapy (Linehan, 2002), crisis consultation if needed, and weekly meetings of the consultation team for all trainers and therapists for one hour. Staff also receives supervision twice-weekly. Patients also receive daily mindfulness classes, 2 hours of drama therapy, psycho educational classes about sexuality, substance abuse and medication, and the possibility to get help in applying principles of validation and behavioral analysis skills.

Behavioral: Inpatient Adaptation of DBT

Outpatient DBT

ACTIVE COMPARATOR

Control condition: Standard outpatient DBT

Behavioral: standard outpatient DBT

Interventions

standard outpatient DBT BEHAVIORAL

Patients receive 12 months of outpatient treatment as specified in the DBT manual (Linehan, 2002) in one of the participating regional psychiatric centers of Rivierduinen. The treatment is according to protocol and combines weekly individual cognitive-behavioral psychotherapy sessions with the primary therapist, weekly skills- training groups, if needed consultation and weekly consultation meetings for trainers and therapists.

Outpatient DBT

Inpatient Adaptation of DBT BEHAVIORAL

The intervention to be studied, inpatient DBT, consists of an inpatient program of 12 weeks. The department provides accommodation for 9 patients. Patients are admitted 5 days a week at the department Oost, part of the Jelgersma centre for Personality Disorders. Staff is only present in daytime. During the weekends the patients stay at home. The therapy consists of DBT skills training (Linehan, 1996), individual psychotherapy (Linehan, 2002), crisis consultation if needed, and weekly meetings of the consultation team for all trainers and therapists for one hour. Staff also receives supervision twice-weekly.

Inpatient Adaptation of DBT

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GGZ Rivierduinen: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

LMC van den Bosch

Oegstgeest, 2342 AN, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 30002832 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Louisa M van den Bosch, PhD

  GGZ Rivierduinen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 22, 2013
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2015
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

NL (1)