An Integrated Approach to Treatment of People With Borderline Personality Disorder and Their Caregivers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Borderline Personality Disorder
- Sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Burden Assessment Scale (BAS) (FC group)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Roberta Rossi
Principal investigator
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Eligibility Criteria
Inclusion Criteria
- •to be outpatient with a DBP diagnosis according to DSM5
- •age between 18 and 50
- •written informed consent
Exclusion Criteria
- •bipolar disorder, psychotic disorders, organic mental disorders, mental retardation, current substance dependence
- •FC intervention:
- •being 18 years of age or older
- •serving as a caregiver or significant other of an individual diagnosed with BPD providing written consent
- •Exclusion Criteria:
- •to have a self-reported acute mental health condition interfering with group participation at that time
Outcomes
Primary Outcomes
Burden Assessment Scale (BAS) (FC group)
Time Frame: Baseline, immediately post-intervention, 4-month follow-up
Change in perceived burden of providing ongoing care to individuals with mental health problems scores. Total score of the BAS ranges from 20 to 80, with higher values indicating stronger burden.
Difficulties in Emotion Regulation Scale (DERS) (DBT group)
Time Frame: Baseline, immediately post-intervention
Change in emotion dysregulation scores on the DERS scale (36 items). Total score of the DERS ranges from 36 to 180 with higher scores indicating higher difficulties in emotion dysregulation.
Grief Scale (GS) (FC group)
Time Frame: Baseline, immediately post-intervention, 4-month follow-up
Change in grief associated with having a loved one with mental illness scores. Total score of the GS ranges from 15 to 75 with higher scores indicating more intense experience of grief.
Secondary Outcomes
- Toronto Alexithymia Scale 20 (TAS-20) (FC group and DBT group)(Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group))
- Family Functioning Questionnaire (FFQ) (FC group)(Baseline, immediately post-intervention, 4-month follow-up)
- Attachment Style Questionnaire (ASQ) (DBT group)(Baseline)
- Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) (DBT group)(Baseline, immediately post-intervention)
- State Trait Anger Expression Inventory (STAXI-2) (FC group and DBT group)(Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group))
- Zanarini Rating scale for BPD (DBT group)(Baseline, immediately post-intervention)
- Childhood Trauma Questionnaire short form (CTQ-SF) (DBT group)(Baseline)
- Beck Depression Inventory II (BDI-II) (FC group and DBT group)(Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group))
- Symptom Check List-90 (SCL-90) (FC group and DBT group)(Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group))
- Barratt Impulsiveness Scale-11 (BIS-11) (DBT group)(Baseline, immediately post-intervention)
- Inventory of Interpersonal Problems (IIP-47) (DBT group)(Baseline, immediately post-intervention)