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Trial record 15 of 607 for:    Personality Disorders

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

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ClinicalTrials.gov Identifier: NCT03717818
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 25, 2018
Sponsor:
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

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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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03717818


Locations
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Switzerland
Department of Psychiatry-CHUV, University of Lausanne Recruiting
Lausanne, VD, Switzerland, 1003
Contact: Ueli Kramer, PhD PD    +41 21 314 00 50    ueli.kramer@chuv.ch   
Sponsors and Collaborators
University of Lausanne Hospitals

Publications of Results:
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Responsible Party: Ueli Kramer, PD Dr. phil. Head of Research, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT03717818     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders