COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Mechanisms of Change in Brief Treatment for Borderline Personality Disorder (BPDCHANGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03717818
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 25, 2018
Information provided by (Responsible Party):
Ueli Kramer, University of Lausanne Hospitals

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Good Psychiatric Management - Brief Behavioral: treatment as usual Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Good Psychiatric Management-Brief Behavioral: Good Psychiatric Management - Brief
specific interventions as defined by Gunderson and Links (2014)

Placebo Comparator: Treatment as Usual-Brief Behavioral: treatment as usual
non-specific intervention

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004) [ Time Frame: 4 months ]
    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

  2. BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009) [ Time Frame: 4 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Borderline Personality Disorder
  • age between 18 and 35

Exclusion Criteria:

  • non-mastery in French
  • neurological disorders
  • schizophrenia (according to DSM-5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03717818

Layout table for location information
Department of Psychiatry-CHUV, University of Lausanne Recruiting
Lausanne, VD, Switzerland, 1003
Contact: Ueli Kramer, PhD PD    +41 21 314 00 50   
Sponsors and Collaborators
University of Lausanne Hospitals

Publications of Results:
Layout table for additonal information
Responsible Party: Ueli Kramer, PD Dr. phil. Head of Research, University of Lausanne Hospitals Identifier: NCT03717818    
Other Study ID Numbers: 2017-02167
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Personality Disorders
Borderline Personality Disorder
Mental Disorders