Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Active, not recruiting NCT04587518 - Five Factor Model Treatment for Borderline Personality Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT03677037 - The Short-Term MBT Project Phase 3
Not yet recruiting NCT05989529 - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed NCT02518906 - Evaluation of AIT Study N/A
Completed NCT02068326 - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Completed NCT02108990 - Acetaminophen and Social Processes Phase 2
Completed NCT01635556 - Evaluation of a Modified Dialectical Behavior Therapy Program N/A
Completed NCT02988037 - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study N/A
Not yet recruiting NCT01683136 - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder N/A
Completed NCT02397031 - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder N/A
Terminated NCT01212588 - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) Phase 2
Terminated NCT01103180 - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder Phase 2
Terminated NCT00539188 - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD Phase 2
Recruiting NCT05398627 - Neurofeedback for Borderline Personality Disorder N/A
Recruiting NCT03994510 - SHame prOpensity in bOrderline Personality Disorder N/A
Recruiting NCT06005129 - Personality Change Study for Borderline Personality Disorder N/A