ClinicalTrials.gg
Status unknownNCT03297840Updated Sep 29, 2017

Change in Mindfulness in Borderline Personality Disorder

An observational study in Mindfulness and Borderline Personality Disorder, sponsored by Katharina Bachmann. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-09-29.

Sponsored by Katharina Bachmann · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
30
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 37 studies in Borderline Personality Disorder with a site in Germany — 6 open to participants now, 7 under way, none of them phase 3. Borderline Personality Disorder · Germany.

Started
2017
with 1 other
Observational
9 of 37
1 open now
Registered
13th of 37
by date
Lead sponsor
2 of 37
Katharina Bachmann

Among the 37 studies in Borderline Personality Disorder with a site in Germany, this one is one of 2 that started in 2017, is one of 9 observational ones, and was the 13th registered.

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

Browse Borderline Personality Disorder studies →

Open to participants now

6 of the 37 studies in Borderline Personality Disorder with a site in Germany are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 37 studies in Borderline Personality Disorder with a site in Germany, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Mindfulness
  • Borderline Personality Disorder
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male and female BPD Patients from 18 to 60 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

Interventions

  • BehavioralDialectical Behavioural Therapy (DBT)

    Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and after 12-weeks

  2. 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).

    Time frame: Baseline and after 12-weeks

  3. 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).

    Time frame: Baseline and after 12-weeks

  4. 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).

    Time frame: Baseline and after 12-weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg
    Bad Zwischenahn, 26160, Germany
    Recruiting
    • Katharina Bachmann, Psych.Msc. · Contact
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for Nov 2017, 6 months after the start.

Of 19 observational studies under Borderline Personality Disorder, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 119. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2017
First posted
Sep 29, 2017
StartActual
May 4, 2017
Primary completionEst.
Nov 2017
CompletionEst.
Dec 2017
Last update
Sep 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03297840
Lead sponsor
Katharina Bachmann
Responsible party
Katharina Bachmann (Psychologist Msc., University of Oldenburg) — Sponsor-investigator
First posted
Sep 29, 2017
Start date
May 4, 2017
Primary completion
Nov 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Sep 29, 2017

Study contacts

Katharina Bachmann, Psych.Msc.
Contact
Katharina.Bachmann@uni-oldenburg.de
00494119615 1506
Alexandra Philipsen, Prof.
principal investigator · Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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