Integrated Intervention for Borderline Personality Disorder and Caregivers
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      This is a prospective, single-arm, open-label study to assess the impact of a group
      intervention for patients with borderline personality disorder (BPD) and a psycho-educational
      intervention for their caregivers. Once participants complete a comprehensive clinical
      assessment, the study involves the participation of those with a BPD diagnosis in Dialectical
      Behavior Therapy (DBT) skills training group, integrated with ongoing routine treatments. A
      battery of questionnaires is administered before and after the DBT skills training to assess
      emotion dysregulation, BPD symptoms severity and other clinical variables. Simultaneously,
      caregivers of individuals with BPD take part in the Family Connections (FC) program. This
      sub-study follows a previous pilot study conducted at the same centre. Family members
      complete assessment questionnaires at three different time points (i.e., at baseline, at
      immediately post-intervention and at a 4-month follow-up) in order to evaluate putative
      positive pre-post changes on burden, grief and other clinical variables. In order to explore
      biomarkers of BPD and stress-related neurobiological mechanisms, blood samples are collected
      from the BPD patient group at pre and post intervention. At baseline, a blood sample is also
      collected to identify stress-related biomarkers among family members.
    

Detailed description: 
      Borderline Personality Disorder (BPD) has a severe impact on the lives of individuals with
      this disorder. Also caregivers of individuals with BPD and related conditions often
      experience higher levels of somatic and psychological distress. Dialectical Behavior Therapy
      (DBT) has been proven to be an effective treatment for BPD and it has been well documented
      that also the module of skills training is effective in the reduction of symptoms. Moreover,
      one of the most well-established programs to support family members of patients with BPD is
      Family Connections (FC). FC showed beneficial effects on severity of depression, well-being
      and family functioning. The aim of the present study is threefold: 1. To evaluate the
      implementation of a DBT skills training program as a complementary intervention in routine
      health care. 2. To assess pre-post changes resulting from a FC intervention in family members
      of individuals with BPD and to identify predictors of positive outcomes. 3. To explore
      potential biomarkers associated with BPD and stress-related neurobiological mechanisms among
      both BPD patients and their family members. Participants are recruited at the IRCCS Centro
      San Giovanni di Dio Fatebenefratelli in Brescia. For the DBT skills training, the primary
      outcome is the reduction of emotion dysregulation. Secondary outcomes encompass measures of
      depression, anxiety, alexithymia, global psychological distress, global functioning,
      impulsiveness, interpersonal problems and severity of BPD symptoms. In addition,
      socio-demographics, trauma history and the presence of non-suicidal self injury or suicide
      attempts are assessed. Within the FC group, primary endpoints are burden and grief scores,
      while secondary endpoints include measurements of depression, alexithymia, global
      psychological distress, family functioning, and feelings of anger. DBT skills training
      consists of 24 weekly sessions that incorporate two acceptance-oriented skills (mindfulness
      and distress tolerance) and two change-oriented skills (emotion regulation and interpersonal
      effectiveness). The FC program, on the other hand, is a 12-week manualized educational and
      skills-building support program rooted in the principles of DBT, administered in a group
      setting to family members of individuals with BPD. Group facilitators possess a medical or
      psychological professional background and have received training in both the DBT and FC
      programs. In addition to psychological assessments, the study involves the collection of
      blood samples from the BPD patient group (before and after the intervention). These samples
      are collected in order to identify potential biomarkers associated with BPD and treatment
      response, including levels of Brain-Derived Neurotrophic Factor (BDNF), expression of
      pro-inflammatory cytokines and anti-inflammatory cytokines, and C-reactive Protein levels.
      Furthermore, the study analyzes stress-related biomarkers such as cortisol levels and
      investigate epigenetic mechanisms through DNA and miRNA metilations analysis. In the FC
      group, a baseline blood sample is also collected to explore stress-related biomarkers.
    

Intervention name(s): DBT skills-training and Family Connections interventions
Intervention type(s): Behavioral
Intervention description(s): DBT skills-training program includes four modules: 1. Mindufulness, 2. Distress Tolerance, 3. Emotion Regulation, 4. Interpersonal effectiveness.
FC program includes six modules: 1. Introduction, 2. Family Education, 3. Relationship Mindfulness Skills, 4. Family Environment Skills, 5. Validation Skills, 6. Problem Management Skills.
Intervention model: Single Group Assignment
Intervention model description: consecutive recruitment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: borderline personality disorder; caregivers; dialectical behavior therapy; biomarkers; emotion dysregulation