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

Primary Purpose

Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
standard outpatient DBT
Inpatient Adaptation of DBT
Sponsored by
Rivierduinen, Centre for Personality disorders Jelgersma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Dialectical Behavior Therapy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LMC van den Bosch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inpatient Adaptation of DBT

Outpatient DBT

Arm Description

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.

Control condition: Standard outpatient DBT

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

assessing change in the severity of borderline symptomatology
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 criteria for borderline personality disorder from the Diagnostic and Statistical Manual-IV.The parasuicide and impulsivity sections have shown reasonable internal consistencies (0.69 and 0.67, respectively), excellent interrater reliability (0.95 and 0.97, respectively) and good concurrent validity ( Arntz et al., 2003). Three month test-retest reliability for the total BPDSI score was 0.77. Patients have reported that they feel acknowledged by the BPDSI for their problems (van den Bosch, 2005).

Full Information

First Posted
July 11, 2013
Last Updated
November 9, 2014
Sponsor
Rivierduinen, Centre for Personality disorders Jelgersma
Collaborators
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01904227
Brief Title
Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT)
Acronym
REDBT
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rivierduinen, Centre for Personality disorders Jelgersma
Collaborators
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder, Dialectical Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inpatient Adaptation of DBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Outpatient DBT
Arm Type
Active Comparator
Arm Description
Control condition: Standard outpatient DBT
Intervention Type
Behavioral
Intervention Name(s)
standard outpatient DBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inpatient Adaptation of DBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
assessing change in number of suicide attempts/self-harming acts
Description
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).
Time Frame
baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Secondary Outcome Measure Information:
Title
assessing change in the severity of borderline symptomatology
Description
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 criteria for borderline personality disorder from the Diagnostic and Statistical Manual-IV.The parasuicide and impulsivity sections have shown reasonable internal consistencies (0.69 and 0.67, respectively), excellent interrater reliability (0.95 and 0.97, respectively) and good concurrent validity ( Arntz et al., 2003). Three month test-retest reliability for the total BPDSI score was 0.77. Patients have reported that they feel acknowledged by the BPDSI for their problems (van den Bosch, 2005).
Time Frame
at baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Other Pre-specified Outcome Measures:
Title
assessing change in level of Quality of life
Description
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being: Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role-Emotional (3 items) and Mental Health (5 items) as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The EuroQol 5 Dimensions descriptive system (EQ-5D) consists of five dimensions (Mobility, Self Care, Usual Activities, Pain/Discomfort and Anxiety/Depression) with three levels each (no problems, some problems and extreme problems), thus defining 243 (35) distinct health states.
Time Frame
baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Title
assessing the cost-effectiveness of the inpatient program compared to the outpatient program
Description
The 'Trimbos and institute for Medical Technology Assessment questionnaire on Costs associated with Psychiatric illness' (TiC-P: Hakkaart- van Roijen, 2010) is a validated tool commonly applied in economic evaluations of treatments in mental health care. The TiC-p consists of two parts. The first part measures direct medical costs. The second part estimates the productivity costs. The number of hospital days and/or outpatient contacts for treatment will also be collected directly from the participating centres. Reference unit prices of health care services will be applied (Hakkaart et al, 2010). The second part of the TiC-P includes a short form of the Health and Labor questionnaire (HLQ) for collecting data on productivity losses (van Roijen et al., 1996).
Time Frame
baseline and 52 weeks after the start of the inpatient treatment
Title
assessing change in level of psychopathological symptoms
Description
The Brief Symptomatology Inventory (BSI; Derogatis & Melisaratos, 1983) includes 49 items grouped into nine scales that encompass nine primary dimensions of psychopathological symptoms: psychoticism, somatization, depression, hostility, phobic anxiety, obsessive-compulsivity, anxiety (panic), paranoid ideation, and nervous tension. As to reliability, Derogatis and Melisaratos (1983) presented appropriate coefficients of internal consistency of the BSI ranging from 0.71 to 0.85 and test-retest reliability coefficients ranging from 0.68 to 0.91. Other studies have reported similar estimates (e. g., Boulett & Boss, 1991; Hayes, 1997). As to validity, Derogatis and Melisaratos (1983) provided evidence for a good construct validity of the BSI.
Time Frame
baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louisa M van den Bosch, PhD
Organizational Affiliation
Rivierduinen, Centre for Personality disorders Jelgersma
Official's Role
Principal Investigator
Facility Information:
Facility Name
LMC van den Bosch
City
Oegstgeest
ZIP/Postal Code
2342 AN
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32368793
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.
Results Reference
derived
PubMed Identifier
30002832
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.
Results Reference
derived

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Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT)

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