Clinical trial NCT06076343: Integrated Intervention for Borderline Personality Disorder and Caregivers
Official title: An Integrated Approach to Treatment of People With Borderline Personality Disorder and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
caregivers
dialectical behavior therapy
biomarkers
emotion dysregulation
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: consecutive recruitment
Primary purpose: TREATMENT

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.

Eligibility criteria: DBT intervention:

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

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS) (DBT group)
timeFrame: Baseline, immediately post-intervention
measure: Burden Assessment Scale (BAS) (FC group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: Grief Scale (GS) (FC group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
Secondary outcomes:
measure: Beck Depression Inventory II (BDI-II) (FC group and DBT group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
measure: Symptom Check List-90 (SCL-90) (FC group and DBT group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
measure: Toronto Alexithymia Scale 20 (TAS-20) (FC group and DBT group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
measure: State Trait Anger Expression Inventory (STAXI-2) (FC group and DBT group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
measure: Family Functioning Questionnaire (FFQ) (FC group)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) (DBT group)
timeFrame: Baseline, immediately post-intervention
measure: Zanarini Rating scale for BPD (DBT group)
timeFrame: Baseline, immediately post-intervention
measure: Childhood Trauma Questionnaire short form (CTQ-SF) (DBT group)
timeFrame: Baseline
measure: Barratt Impulsiveness Scale-11 (BIS-11) (DBT group)
timeFrame: Baseline, immediately post-intervention
measure: Inventory of Interpersonal Problems (IIP-47) (DBT group)
timeFrame: Baseline, immediately post-intervention
measure: Attachment Style Questionnaire (ASQ) (DBT group)
timeFrame: Baseline
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
state: BS
Study officials:
affiliation: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
name: Roberta Rossi, psychologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.
citation: McMain SF, Links PS, Gnam WH, Guimond T, Cardish RJ, Korman L, Streiner DL. A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1365-74. doi: 10.1176/appi.ajp.2009.09010039. Epub 2009 Sep 15.
citation: Hoffman PD, Fruzzetti AE, Buteau E, Neiditch ER, Penney D, Bruce ML, Hellman F, Struening E. Family connections: a program for relatives of persons with borderline personality disorder. Fam Process. 2005 Jun;44(2):217-25. doi: 10.1111/j.1545-5300.2005.00055.x.
citation: Liljedahl SI, Kleindienst N, Wangby-Lundh M, Lundh LG, Daukantaite D, Fruzzetti AE, Westling S. Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study. Borderline Personal Disord Emot Dysregul. 2019 Aug 26;6:14. doi: 10.1186/s40479-019-0111-6. eCollection 2019.
citation: Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.