Borderline Personality DisorderREDBTNCT01904227
Intensified, Inpatient Adaptation of Dialectical Behavior Therapy (DBT)
A study testing standard outpatient DBT and Inpatient Adaptation of DBT in people with Borderline Personality Disorder, run by GGZ Rivierduinen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- standard outpatient DBT and Inpatient Adaptation of DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- standard outpatient DBT, Inpatient Adaptation of DBT
- Keywords
- Borderline Personality Disorder, Dialectical Behavior Therapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard outpatient DBTBehavioural
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.
Inpatient Adaptation of DBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Inpatient Adaptation of DBT |
| Outpatient DBT | Active comparator | Control condition: Standard outpatient DBT Receives: Behavioral: standard outpatient DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: at baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionAug 2014
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GGZ Rivierduinen
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Louisa M van den Bosch, PhD, Principal investigator, GGZ Rivierduinen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904227
- Sponsor's protocol ID
- Rivierduinen 2012
- Acronym
- REDBT
- Status last verified
- Nov 2014
- First submitted
- 11 Jul 2013
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32368793Sinnaeve 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.
PubMed 30002832
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01904227
- Acronym / sponsor ID
- REDBT / Rivierduinen 2012
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Dialectical Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GGZ RivierduinenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- Feb 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient Adaptation of DBT | Experimental | Behavioral: Inpatient Adaptation of DBTPatients 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. |
| Outpatient DBT | Active comparator | Behavioral: standard outpatient DBTControl condition: Standard outpatient DBT |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Intelligence Quotient < 80,
- a chronic psychotic condition,
- bipolar disorder,
- hard drug abuse that requires inpatient detoxification,
- forced treatment framework,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard outpatient DBTPatients 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. | Behavioural | Outpatient DBT |
| Inpatient Adaptation of DBTThe 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. | Behavioural | Inpatient Adaptation of DBT |
Primary outcome
assessing change in number of suicide attempts/self-harming acts
Time frame: baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
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).
1 secondary outcome
assessing change in the severity of borderline symptomatology
Time frame: at baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 30002832Sinnaeve 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa M van den Bosch, PhD principal investigator
GGZ Rivierduinen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard outpatient DBT and Inpatient Adaptation of DBT in people with Borderline Personality Disorder, run by GGZ Rivierduinen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing change in number of suicide attempts/self-harming acts (time frame: baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.