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

Primary Purpose

Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Good Psychiatric Management - Brief
treatment as usual
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Borderline Personality Disorder
  • age between 18 and 35

Exclusion Criteria:

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

Sites / Locations

  • Department of Psychiatry-CHUV, University of LausanneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Good Psychiatric Management-Brief

Treatment as Usual-Brief

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
October 22, 2018
Last Updated
October 23, 2018
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03717818
Brief Title
Mechanisms of Change in Brief Treatment for Borderline Personality Disorder
Acronym
BPDCHANGE
Official Title
Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Good Psychiatric Management-Brief
Arm Type
Experimental
Arm Title
Treatment as Usual-Brief
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Good Psychiatric Management - Brief
Intervention Description
specific interventions as defined by Gunderson and Links (2014)
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Intervention Description
non-specific intervention
Primary Outcome Measure Information:
Title
ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)
Description
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
Time Frame
4 months
Title
BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Borderline Personality Disorder age between 18 and 35 Exclusion Criteria: non-mastery in French neurological disorders schizophrenia (according to DSM-5)
Facility Information:
Facility Name
Department of Psychiatry-CHUV, University of Lausanne
City
Lausanne
State/Province
VD
ZIP/Postal Code
1003
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ueli Kramer, PhD PD
Phone
+41 21 314 00 50
Email
ueli.kramer@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30507735
Citation
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.
Results Reference
result
PubMed Identifier
32299512
Citation
Kramer 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.
Results Reference
derived

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Mechanisms of Change in Brief Treatment for Borderline Personality Disorder

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