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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03717818
Other study ID # 2017-02167
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 19, 2018
Est. completion date December 2022

Study information

Verified date October 2018
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Borderline Personality Disorder

- age between 18 and 35

Exclusion Criteria:

- non-mastery in French

- neurological disorders

- schizophrenia (according to DSM-5)

Study Design


Intervention

Behavioral:
Good Psychiatric Management - Brief
specific interventions as defined by Gunderson and Links (2014)
treatment as usual
non-specific intervention

Locations

Country Name City State
Switzerland Department of Psychiatry-CHUV, University of Lausanne Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Kramer U, Kolly S, Maillard P, Pascual-Leone A, Samson AC, Schmitt R, Bernini R, Allenbach, G, Charbon P, de Roten Y, Conus P, Despland JN, Draganski B. Change in emotional processing and theory of mind processing in borderline personality disorder: A pil

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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