Borderline Personality DisorderNCT03149926
Emotional Reaction and Self Injury in Patients With Borderline Personality Disorder and Healthy Controls
An observational study of Borderline Personality Disorder and Emotions, run by Katharina Bachmann at 1 site in Germany.
Trial summary
The current study investigates the emotional response of patients with borderline personality disorder and healthy controls on stimuli associated with self-injury. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Emotions
- What is being tested?
- Stimuli presentation
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2017to Feb 2018
- 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
- Healthy volunteers accepted
- Adult
Study population: Patients with Borderline personality disorder that are current in treatment in the inpatient dialectical behavioral therapy unit of the universityhospitel or have completed the treatment. Matched, healthy controls without psychiatric disorders
Who may be able to join
- Patients that are able to use skills and have some therapy experiences.
Who cannot join
- Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg
Bad Zwischenahn, 26160
About this study
Official title: Emotional Reaction of Patients With Borderline Personality Disorder (BPD)on Stimuli Connected to Self-injury - A Comparison Between Patients With BPD and a Healthy Control Group.
The current study investigates the emotional response of patients with borderline personality disorder and healthy controls on stimuli associated with self-injury.
- Conditions
- Borderline Personality Disorder, Emotions
- Being tested
- Stimuli presentation
- 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.
Stimuli presentationOther
Different stimuli associated with self-injury are presented. Participants have to rate the emotional effect elected by the stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Borderline Personality Disorder | Not described Receives: Other: Stimuli presentation | |
| Healthy controls | Not described Receives: Other: Stimuli presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional reaction
Patients comparded to healthy controls will show a stronger emotional reaction on the stimuli.
Patients more severely affected will show a stronger emotional reaction compared to less affected patients.
Measured: one session of 90min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (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 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
- Other
- Time perspective
- Other
- Enrolment
- 60 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
- NCT03149926
- Sponsor's protocol ID
- UOldenburg2
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bachmann K, Schulze M, Soros P, Schmahl C, Philipsen A. Development and validation of an emotional picture set of self-injury (EPSI) for borderline personality disorder: protocol for a validation study. BMJ Open. 2019 May 22;9(5):e027063. doi: 10.1136/bmjopen-2018-027063.
PubMed 31122985
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Reaction of Patients With Borderline Personality Disorder (BPD)on Stimuli Connected to Self-injury - A Comparison Between Patients With BPD and a Healthy Control Group.
- ClinicalTrials.gov ID
- NCT03149926
- Acronym / sponsor ID
- UOldenburg2
- Conditions
- Borderline Personality Disorder, Emotions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Katharina BachmannUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 11 May 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 investigates the emotional response of patients with borderline personality disorder and healthy controls on stimuli associated with self-injury.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Borderline Personality Disorder | – | Other: Stimuli presentation |
| Healthy controls | – | Other: Stimuli presentation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Borderline personality disorder that are current in treatment in the inpatient dialectical behavioral therapy unit of the universityhospitel or have completed the treatment. Matched, healthy controls without psychiatric disorders
Key inclusion criteria (1 listed)
- Patients that are able to use skills and have some therapy experiences.
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 |
|---|---|---|
| Stimuli presentationDifferent stimuli associated with self-injury are presented. Participants have to rate the emotional effect elected by the stimuli. | Other | Healthy controls, Patients with Borderline Personality Disorder |
Primary outcome
Emotional reaction
Time frame: one session of 90min
Patients comparded to healthy controls will show a stronger emotional reaction on the stimuli. Patients more severely affected will show a stronger emotional reaction compared to less affected patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 31122985Bachmann K, Schulze M, Soros P, Schmahl C, Philipsen A. Development and validation of an emotional picture set of self-injury (EPSI) for borderline personality disorder: protocol for a validation study. BMJ Open. 2019 May 22;9(5):e027063. doi: 10.1136/bmjopen-2018-027063.
- Individual participant dataSharing planned: Undecided
Related trials for Borderline Personality Disorder
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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
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MDMA in Borderline Personality Disorder
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Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
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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 Borderline Personality Disorder and Emotions, 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 1 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 12 May 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?
Emotional reaction (time frame: one session of 90min). 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 NCT03149926, 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 May 2017.