MindfulnessNCT03297840
Change in Mindfulness in Borderline Personality Disorder
An observational study of Mindfulness and Borderline Personality Disorder, run by Katharina Bachmann at 1 site in Germany.
Trial summary
The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mindfulness, Borderline Personality Disorder
- What is being tested?
- Dialectical Behavioural Therapy (DBT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 4 May 2017to Dec 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Male and female BPD Patients from 18 to 60 years.
Who may be able to join
- Clinical diagnosis of Borderline Personality Disorder
- On the waitlist for DBT treatment or actually treated with DBT
- Not previously treated with DBT.
Who cannot join
- Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg
Bad Zwischenahn, 26160
Katharina Bachmann, Psych.Msc.
About this study
Official title: Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.
Read the detailed description
Participants will be recruited from the Dialectical-Behavioral-Therapy (DBT) unit. DBT is a treatment approach that has been shown to be effective in the treatment of Borderline Personality Disorder. DBT integrates different psychotherapeutic interventions as well as Mindfulness Meditation exercises. Mindfulness is a meditation practice that can improve present moment awareness. When applied as therapeutic intervention mindfulness meditation can help patients to stay with their attention in the present moment, to be aware what is happening in the here and now, and to better identify and regulate upcoming emotions.
The current observational study investigates changes in symptom severity and mindfulness skills during DBT treatment. A treatment group will be compared to a waitlist control group. The two groups are predefined by routine medical care.
Symptom severity and mindfulness skills will be assessed at baseline (before treatment or when accepted for the waitlist) and after 12-weeks. A within and between group analyses will be performed.
- Conditions
- Mindfulness, Borderline Personality Disorder
- Being tested
- Dialectical Behavioural Therapy (DBT)
- 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.
Dialectical Behavioural Therapy (DBT)Behavioural
Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients with Borderline Personality Disorder receiving DBT treatment. Measurement takes place at the beginning of the treatment and a second time after 12-weeks treatment. Receives: Behavioral: Dialectical Behavioural Therapy (DBT) | |
| Waitlist | Patients with Borderline Personality Disorder on the waitlist for inpatient DBT treatment. Measurement takes place twice at baseline and after 12-weeks waiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mindfulness
Degree of mindfulness will be assessed by the Kentucky Inventory of Mindfulness Skills, German Version (KIMS-D). A within and between group comparison will be performed (treatment vs. waitlist).
Measured: Baseline and after 12-weeks
Change in borderline symptom severity
Change in Borderline symptom severity is measured by the Borderline Symptom List (BSL 23). A within and between group comparison will be performed (treatment vs. waitlist).
Measured: Baseline and after 12-weeks
Change in overall psychiatric symptom severity
Change in overall symptom severity is measured by the Change in symptomseverity is measured by the Symptom-Checklist-90®-Standard (SCL-90). A within and between group comparison will be performed (treatment vs. waitlist).
Measured: Baseline and after 12-weeks
Change in severity in symptoms of depression
Change in overall symptom severity is measured by the Beck depression inventory (BDI). A within and between group comparison will be performed (treatment vs. waitlist).
Measured: Baseline and after 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start4 May 2017
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
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 MindfulnessStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katharina Bachmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katharina Bachmann, University of Oldenburg
- Investigators
- Alexandra Philipsen, Prof., Principal investigator, Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297840
- Sponsor's protocol ID
- Mindfullness in BPD
- Status last verified
- Sep 2017
- First submitted
- 9 May 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32368793
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
- ClinicalTrials.gov ID
- NCT03297840
- Acronym / sponsor ID
- Mindfullness in BPD
- Conditions
- Mindfulness, Borderline Personality Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Katharina BachmannUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Sep 2017 (actual)
- 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.
The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.
Detailed description
Participants will be recruited from the Dialectical-Behavioral-Therapy (DBT) unit. DBT is a treatment approach that has been shown to be effective in the treatment of Borderline Personality Disorder. DBT integrates different psychotherapeutic interventions as well as Mindfulness Meditation exercises. Mindfulness is a meditation practice that can improve present moment awareness. When applied as therapeutic intervention mindfulness meditation can help patients to stay with their attention in the present moment, to be aware what is happening in the here and now, and to better identify and regulate upcoming emotions.
The current observational study investigates changes in symptom severity and mindfulness skills during DBT treatment. A treatment group will be compared to a waitlist control group. The two groups are predefined by routine medical care.
Symptom severity and mindfulness skills will be assessed at baseline (before treatment or when accepted for the waitlist) and after 12-weeks. A within and between group analyses will be performed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Behavioral: Dialectical Behavioural Therapy (DBT)Patients with Borderline Personality Disorder receiving DBT treatment. Measurement takes place at the beginning of the treatment and a second time after 12-weeks treatment. |
| Waitlist | – | –Patients with Borderline Personality Disorder on the waitlist for inpatient DBT treatment. Measurement takes place twice at baseline and after 12-weeks waiting. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male and female BPD Patients from 18 to 60 years.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Borderline Personality Disorder
- On the waitlist for DBT treatment or actually treated with DBT
- Not previously treated with DBT.
Key exclusion criteria (1 listed)
- Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
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 Behavioural Therapy (DBT)Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan. | Behavioural | Treatment |
Primary outcome
Change in mindfulness
Time frame: Baseline and after 12-weeks
Degree of mindfulness will be assessed by the Kentucky Inventory of Mindfulness Skills, German Version (KIMS-D). A within and between group comparison will be performed (treatment vs. waitlist).
Change in borderline symptom severity
Time frame: Baseline and after 12-weeks
Change in Borderline symptom severity is measured by the Borderline Symptom List (BSL 23). A within and between group comparison will be performed (treatment vs. waitlist).
Change in overall psychiatric symptom severity
Time frame: Baseline and after 12-weeks
Change in overall symptom severity is measured by the Change in symptomseverity is measured by the Symptom-Checklist-90®-Standard (SCL-90). A within and between group comparison will be performed (treatment vs. waitlist).
Change in severity in symptoms of depression
Time frame: Baseline and after 12-weeks
Change in overall symptom severity is measured by the Beck depression inventory (BDI). A within and between group comparison will be performed (treatment vs. waitlist).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Alexandra Philipsen, Prof. principal investigator
Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany
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 Mindfulness and Borderline Personality Disorder, run by Katharina Bachmann 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 3 inclusion and 1 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 29 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharina Bachmann, Psych.Msc. (00494119615 1506, Katharina.Bachmann@uni-oldenburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mindfulness (time frame: Baseline and after 12-weeks). The study lists 4 primary outcomes in all. 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 NCT03297840, 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 29 Sep 2017.