Mechanisms of Change in Brief Treatment for Borderline Personality Disorder

Study Overview
=================
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).

Official Title
-----------------
Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Good Psychiatric Management - Brief
* Behavioral: treatment as usual


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Good Psychiatric Management-Brief<br> | Behavioral: Good Psychiatric Management - Brief<br>* specific interventions as defined by Gunderson and Links (2014)<br>|
| Placebo Comparator: Treatment as Usual-Brief<br> | Behavioral: treatment as usual<br>* non-specific intervention<br>|

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 |