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

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).

Study Overview

• Status: Unknown
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Good Psychiatric Management - Brief; Behavioral: treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1003
      • Recruiting
      • Department of Psychiatry-CHUV, University of Lausanne
      • Contact: Ueli Kramer, PhD PD; Phone Number: +41 21 314 00 50; Email: ueli.kramer@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Borderline Personality Disorder
• age between 18 and 35

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	4 months

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 2017-02167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No