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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03297840
Other study ID # Mindfullness in BPD
Secondary ID
Status Recruiting
Phase N/A
First received May 9, 2017
Last updated September 26, 2017
Start date May 4, 2017
Est. completion date December 2017

Study information

Verified date September 2017
Source University of Oldenburg
Contact Katharina Bachmann, Psych.Msc.
Phone 00494119615 1506
Email Katharina.Bachmann@uni-oldenburg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Behavioral:
Dialectical Behavioural Therapy (DBT)
Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.

Locations

Country Name City State
Germany Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg Bad Zwischenahn

Sponsors (1)

Lead Sponsor Collaborator
Katharina Bachmann

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline and after 12-weeks
Primary 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). Baseline and after 12-weeks
Primary 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). Baseline and after 12-weeks
Primary 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). Baseline and after 12-weeks
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