Mechanisms of Change in Brief Treatment for Borderline Personality Disorder

NCT03717818 | Unknown DMC

• 1 other identifier: 2017-02167
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)

  4 months

• BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)

  4 months

Study Arms (2)

Good Psychiatric Management-Brief

EXPERIMENTAL

Behavioral: Good Psychiatric Management - Brief

Treatment as Usual-Brief

PLACEBO COMPARATOR

Behavioral: treatment as usual

Interventions

Good Psychiatric Management - Brief BEHAVIORAL

specific interventions as defined by Gunderson and Links (2014)

Good Psychiatric Management-Brief

treatment as usual BEHAVIORAL

non-specific intervention

Treatment as Usual-Brief

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Borderline Personality Disorder
• age between 18 and 35

You may not qualify if:

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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Department of Psychiatry-CHUV, University of Lausanne

Lausanne, Canton of Vaud, 1003, Switzerland

RECRUITING

Related Publications (3)

• 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.

  PMID: 30507735 RESULT

• Kramer 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.

  PMID: 39696018 DERIVED

• 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.

  PMID: 32299512 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. phil. Head of Research

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: October 19, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)