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Integrated Intervention for Borderline Personality Disorder and Caregivers

NCT06076343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

  • Borderline Personality Disorder

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Roberta Rossi, psychologist · IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-06-15
Completion
2022-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076343 on ClinicalTrials.gov