Borderline Personality DisorderNCT03018639
Impact of Therapist Change on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving DBT
An observational study of Borderline Personality Disorder and PostTraumatic Stress Disorder, run by Evangelisches Krankenhaus Bielefeld gGmbH at 1 site in Germany.
Trial summary
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, PostTraumatic Stress Disorder, Psychotherapy
- What is being tested?
- Dialectical Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Aug 2016
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For this study, all patients aged from 18 to 65, discharged from our personality disorder inpatient unit between December 2012 and August 2016, and fulfilling three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were considered (n = 89).
Who may be able to join
- three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC)
Who cannot join
- inability to contract and consent,
- other severe mental disorders (bipolar disorder, acute psychosis),
- current alcohol,
- illicit or not prescribed drug use,
- simultaneous participation in other treatment studies,
- pregnancy or breastfeeding,
Show all 9Show fewer
- an inability to negotiate a non-suicide agreement,
- ongoing traumatic contact with the perpetrator, and
- a Body Mass Index < 16.5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Therapist Change After Initial Contact and Traumatic Burden on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving Dialectical Behavior Therapy
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. Beyond that, changes of therapists were documented.
- Being tested
- Dialectical Behavior Therapy
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior TherapyBehavioural
DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy | The program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors. Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD. Receives: Behavioral: Dialectical Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Bielefeld gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolin Steuwe, Evangelisches Krankenhaus Bielefeld gGmbH
- Investigators
- Martin Driessen, Study director, Research Department, Ev. Krankenhaus Bielefeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018639
- Sponsor's protocol ID
- DBT_dropout
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Steuwe C, Berg M, Driessen M, Beblo T. Impact of therapist change after initial contact and traumatic burden on dropout in a naturalistic sample of inpatients with borderline pathology receiving dialectical behavior therapy. Borderline Personal Disord Emot Dysregul. 2017 Jun 22;4:14. doi: 10.1186/s40479-017-0067-3. eCollection 2017.
PubMed 28649383
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapist Change After Initial Contact and Traumatic Burden on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving Dialectical Behavior Therapy
- ClinicalTrials.gov ID
- NCT03018639
- Acronym / sponsor ID
- DBT_dropout
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Evangelisches Krankenhaus Bielefeld gGmbHUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Jan 2017 (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.
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. Beyond that, changes of therapists were documented.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy | – | Behavioral: Dialectical Behavior TherapyThe program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors. Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, all patients aged from 18 to 65, discharged from our personality disorder inpatient unit between December 2012 and August 2016, and fulfilling three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were considered (n = 89).
Key inclusion criteria (1 listed)
- three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC)
Key exclusion criteria (9 listed)
- inability to contract and consent,
- other severe mental disorders (bipolar disorder, acute psychosis),
- current alcohol,
- illicit or not prescribed drug use,
- simultaneous participation in other treatment studies,
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 |
|---|---|---|
| Dialectical Behavior TherapyDBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993). | Behavioural | Dialectical Behavior Therapy |
Primary outcome
Dropout
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 28649383Steuwe C, Berg M, Driessen M, Beblo T. Impact of therapist change after initial contact and traumatic burden on dropout in a naturalistic sample of inpatients with borderline pathology receiving dialectical behavior therapy. Borderline Personal Disord Emot Dysregul. 2017 Jun 22;4:14. doi: 10.1186/s40479-017-0067-3. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Martin Driessen study director
Research Department, Ev. Krankenhaus Bielefeld
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder and PostTraumatic Stress Disorder, run by Evangelisches Krankenhaus Bielefeld gGmbH at 1 site in Germany.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 12 Jan 2017. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dropout (time frame: 10 weeks). 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 NCT03018639, which also lists 1 linked publication.
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 12 Jan 2017.