Borderline Personality DisorderBPDCHANGENCT03717818
Mechanisms of Change in Brief Treatment for Borderline Personality Disorder
A study testing Good Psychiatric Management - Brief and treatment as usual in people with Borderline Personality Disorder, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Good Psychiatric Management - Brief and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Oct 2018to 31 Oct 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Borderline Personality Disorder
- age between 18 and 50
Who cannot join
- non-mastery in French
- neurological disorders
- schizophrenia (according to DSM-5)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Psychiatry-CHUV, University of Lausanne
Lausanne, Canton of Vaud, 1003
About this study
Official title: Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial
The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).
- Conditions
- Borderline Personality Disorder
- Being tested
- Good Psychiatric Management - Brief, treatment as usual
- 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.
Good Psychiatric Management - BriefBehavioural
specific interventions as defined by Gunderson and Links (2014)
treatment as usualBehavioural
non-specific intervention
| Study group | Role | What they receive |
|---|---|---|
| Good Psychiatric Management-Brief | Experimental | Not described Receives: Behavioral: Good Psychiatric Management - Brief |
| Treatment as Usual-Brief | Placebo comparator | Not described Receives: Behavioral: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)
measures borderline symptomatology from an dimensional perspective, ranges between 0 and 36 (36 being the most symptomatic), global score (sum of all 9 items coded between 0 and 4) used.
Measured: 4 months
Emotional processing: Classification of Affective Meaning States (CAMS;Pascual-Leone, 2009)
based on two chair dialogues, changes between months 0 and 2 mediate the symptom changes between months 2 and 4
Measured: months 0 to 2 mediate symptom change between months 2 and 4
Secondary outcomes (2)
OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)
measures the level of problems (distress, social and interpersonal) on a scale ranging from 0 to 180 (45 items coded between 0 and 4, 4 being the most symptomatic). A total sum score will be used
Measured: 4 months
BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)
measures the intensity of borderline symptoms using a mean score of the 23 items ranging between 0 and 4 (4 being the most symptomatic), the mean score will be used.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start19 Oct 2018
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ueli Kramer, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717818
- Sponsor's protocol ID
- 2017-02167
- Other IDs
- 2017
- Acronym
- BPDCHANGE
- Status last verified
- Jun 2024
- First submitted
- 22 Oct 2018
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kramer U, Kolly S, Maillard P, Pascual-Leone A, Samson AC, Schmitt R, Bernini A, Allenbach G, Charbon P, de Roten Y, Conus P, Despland JN, Draganski B. Change in Emotional and Theory of Mind Processing in Borderline Personality Disorder: A Pilot Study. J Nerv Ment Dis. 2018 Dec;206(12):935-943. doi: 10.1097/NMD.0000000000000905.
PubMed 30507735Kramer U, Grandjean L, Beuchat H, Kolly S, Conus P, de Roten Y, Draganski B, Despland JN. Mechanisms of change in brief treatments for borderline personality disorder: a protocol of a randomized controlled trial. Trials. 2020 Apr 16;21(1):335. doi: 10.1186/s13063-020-4229-z.
PubMed 32299512Yilmaz M, Grandjean L, Beuchat H, Ranjbar S, de Roten Y, Felici C, Lingiardi V, Kramer U. Predicting Change in Brief Treatment for BPD: The Role of Defensive Functioning and Pervasiveness in Relationship Patterns. J Clin Psychol. 2026 Sep;82(9):1352-1364. doi: 10.1002/jclp.70161. Epub 2026 Jun 2.
PubMed 42228959Kramer U, Grandjean L, Machinea JB, Beuchat H, Ranjbar S, de Roten Y, Despland JN, Conus P, Kolly S. Emotional processing as mechanism of change in brief good psychiatric management for borderline personality disorder: results of a randomized controlled trial. BMC Psychiatry. 2024 Dec 18;24(1):921. doi: 10.1186/s12888-024-06370-2.
PubMed 39696018
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03717818
- Acronym / sponsor ID
- BPDCHANGE / 2017-02167
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Oct 2018 (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 present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Psychiatric Management-Brief | Experimental | Behavioral: Good Psychiatric Management - Brief |
| Treatment as Usual-Brief | Placebo comparator | Behavioral: treatment as usual |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Borderline Personality Disorder
- age between 18 and 50
Key exclusion criteria (3 listed)
- non-mastery in French
- neurological disorders
- schizophrenia (according to DSM-5)
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 |
|---|---|---|
| Good Psychiatric Management - Briefspecific interventions as defined by Gunderson and Links (2014) | Behavioural | Good Psychiatric Management-Brief |
| treatment as usualnon-specific intervention | Behavioural | Treatment as Usual-Brief |
Primary outcome
ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)
Time frame: 4 months
measures borderline symptomatology from an dimensional perspective, ranges between 0 and 36 (36 being the most symptomatic), global score (sum of all 9 items coded between 0 and 4) used.
Emotional processing: Classification of Affective Meaning States (CAMS;Pascual-Leone, 2009)
Time frame: months 0 to 2 mediate symptom change between months 2 and 4
based on two chair dialogues, changes between months 0 and 2 mediate the symptom changes between months 2 and 4
2 secondary outcomes
OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)
Time frame: 4 months
BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)
Time frame: 4 months
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 29 Oct 2026.
- Results publication: PubMed 30507735Kramer U, Kolly S, Maillard P, Pascual-Leone A, Samson AC, Schmitt R, Bernini A, Allenbach G, Charbon P, de Roten Y, Conus P, Despland JN, Draganski B. Change in Emotional and Theory of Mind Processing in Borderline Personality Disorder: A Pilot Study. J Nerv Ment Dis. 2018 Dec;206(12):935-943. doi: 10.1097/NMD.0000000000000905.
- Results publication: PubMed 32299512Kramer U, Grandjean L, Beuchat H, Kolly S, Conus P, de Roten Y, Draganski B, Despland JN. Mechanisms of change in brief treatments for borderline personality disorder: a protocol of a randomized controlled trial. Trials. 2020 Apr 16;21(1):335. doi: 10.1186/s13063-020-4229-z.
- Derived from this study: PubMed 42228959Yilmaz M, Grandjean L, Beuchat H, Ranjbar S, de Roten Y, Felici C, Lingiardi V, Kramer U. Predicting Change in Brief Treatment for BPD: The Role of Defensive Functioning and Pervasiveness in Relationship Patterns. J Clin Psychol. 2026 Sep;82(9):1352-1364. doi: 10.1002/jclp.70161. Epub 2026 Jun 2.
- Derived from this study: PubMed 39696018Kramer U, Grandjean L, Machinea JB, Beuchat H, Ranjbar S, de Roten Y, Despland JN, Conus P, Kolly S. Emotional processing as mechanism of change in brief good psychiatric management for borderline personality disorder: results of a randomized controlled trial. BMC Psychiatry. 2024 Dec 18;24(1):921. doi: 10.1186/s12888-024-06370-2.
- Individual participant dataSharing planned: Yes
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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 Good Psychiatric Management - Brief and treatment as usual in people with Borderline Personality Disorder, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 2 inclusion and 3 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 29 Oct 2026. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003) (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT03717818, which also lists 4 linked publications.
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 29 Oct 2026.