Integrated Intervention for Borderline Personality Disorder and Caregivers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Suicidal Women With Borderline Personality Disorder

NCT00183651

Borderline Personality Disorder Suicide

COMPLETED PHASE2

Promoting Recovery Processes in Women With Borderline Personality Disorder Using a Dynamic Cognitive Intervention

NCT01531634

Borderline Personality Disorder

UNKNOWN NA

Internal Family Systems Therapy for Borderline Personality Disorder

NCT07342907

Borderline Personality Disorder (BPD)

RECRUITING NA

Testing an Alliance-Focused Dialectical Behaviour Therapy Training for Borderline Personality Disorder

NCT07119541

Borderline Personality Disorder Emotion Dysregulation

ACTIVE_NOT_RECRUITING NA

Change in Mindfulness in Borderline Personality Disorder

NCT03297840

Mindfulness Borderline Personality Disorder

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Borderline Personality Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

consecutive recruitment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dialectical behavior therapy/Family Connections

Outpatients with a diagnosis of BPD will be assigned to DBT skills-training intervention (6-10 participants per group). Each DBT skills-training group will receive 24 sessions. Family members of people with BPD will be assigned to psychoeducational intervention. Each FC group (10-12 participants) will receive 12 sessions. Each session for BPD patients and for caregivers lasts 1.5 hours and it is conducted by a leader and a co-leader (two trained psychotherapists).

Group Type EXPERIMENTAL

DBT skills-training and Family Connections interventions

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DBT skills-training and Family Connections interventions

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\- to have a self-reported acute mental health condition interfering with group participation at that time

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes