- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297840
Change in Mindfulness in Borderline Personality Disorder
Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Katharina Bachmann, Psych.Msc.
- Phone Number: 00494119615 1506
- Email: Katharina.Bachmann@uni-oldenburg.de
Study Locations
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Bad Zwischenahn, Germany, 26160
- Recruiting
- Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg
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Contact:
- Katharina Bachmann, Psych.Msc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of Borderline Personality Disorder
- On the waitlist for DBT treatment or actually treated with DBT
- Not previously treated with DBT.
Exclusion Criteria:
- Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.
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Waitlist
Patients with Borderline Personality Disorder on the waitlist for inpatient DBT treatment.
Measurement takes place twice at baseline and after 12-weeks waiting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mindfulness
Time Frame: Baseline and after 12-weeks
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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).
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Baseline and after 12-weeks
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Change in borderline symptom severity
Time Frame: Baseline and after 12-weeks
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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).
|
Baseline and after 12-weeks
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Change in overall psychiatric symptom severity
Time Frame: Baseline and after 12-weeks
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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).
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Baseline and after 12-weeks
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Change in severity in symptoms of depression
Time Frame: Baseline and after 12-weeks
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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).
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Baseline and after 12-weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra Philipsen, Prof., Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mindfullness in BPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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