Borderline Personality DisorderSOKO-1NCT04504994
Stress & Social Cognition in Borderline Personality Disorder
A study testing inclusion condition in people with Borderline Personality Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- inclusion condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to 1 Dec 2021
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female patients with BPD and healthy control women, matched for age, body mass index, and education
Who cannot join
- physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Fight-or-flight" Versus "Tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.
Read the detailed description
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight" pattern is also seen in other relevant aspects of social behavior, such as sharing and punishment behavior. To induce social exclusion all participants will play cyberball, either the exclusion condition or the (over)inclusion condition before testing
- Conditions
- Borderline Personality Disorder
- Being tested
- inclusion condition
- 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.
inclusion conditionBehavioural
cyberball game: ex- versus over-inclusion condition
| Study group | Role | What they receive |
|---|---|---|
| exclusion BPD | Experimental | cyberball exclusion condition - BPD patients Receives: Behavioral: inclusion condition |
| over-inclusion BPD | Experimental | cyberball over-inclusion condition - BPD patients Receives: Behavioral: inclusion condition |
| exclusion healthy controls | Experimental | cyberball exclusion condition - healthy controls Receives: Behavioral: inclusion condition |
| over-inclusion healthy controls | Experimental | cyberball over-inclusion condition - healthy controls Receives: Behavioral: inclusion condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
empathy
Multifaceted Empathy Test
Measured: 30 minutes after cyberball
Secondary outcomes (1)
sharing behavior: amount of monetary units (max 30) shared with co-player
Computer game
Measured: directly after cyberball
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Feb 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Wingenfeld, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504994
- Sponsor's protocol ID
- WI 3396/12-1
- Acronym
- SOKO-1
- Status last verified
- Mar 2022
- First submitted
- 30 Jul 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Fight-or-flight" Versus "Tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I
- ClinicalTrials.gov ID
- NCT04504994
- Acronym / sponsor ID
- SOKO-1 / WI 3396/12-1
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Aug 2020 (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 investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.
Detailed description
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight" pattern is also seen in other relevant aspects of social behavior, such as sharing and punishment behavior. To induce social exclusion all participants will play cyberball, either the exclusion condition or the (over)inclusion condition before testing
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| exclusion BPD | Experimental | Behavioral: inclusion conditioncyberball exclusion condition - BPD patients |
| over-inclusion BPD | Experimental | Behavioral: inclusion conditioncyberball over-inclusion condition - BPD patients |
| exclusion healthy controls | Experimental | Behavioral: inclusion conditioncyberball exclusion condition - healthy controls |
| over-inclusion healthy controls | Experimental | Behavioral: inclusion conditioncyberball over-inclusion condition - healthy controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female patients with BPD and healthy control women, matched for age, body mass index, and education
Key exclusion criteria (1 listed)
- physical illness
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 |
|---|---|---|
| inclusion conditioncyberball game: ex- versus over-inclusion condition | Behavioural | exclusion BPD, exclusion healthy controls, over-inclusion BPD, over-inclusion healthy controls |
Primary outcome
empathy
Time frame: 30 minutes after cyberball
Multifaceted Empathy Test
1 secondary outcome
sharing behavior: amount of monetary units (max 30) shared with co-player
Time frame: directly after cyberball
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inclusion condition in people with Borderline Personality Disorder, run by Charite University, Berlin, Germany 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: finished, as of the sponsor's last update on 15 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
empathy (time frame: 30 minutes after cyberball). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.