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Clinical Trials/NCT06074289
NCT06074289
Completed
N/A

Psycho-educational Program for Family Members of People With Borderline Personality Disorder

IRCCS Centro San Giovanni di Dio Fatebenefratelli0 sites89 target enrollmentDecember 16, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Family Caregivers
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Enrollment
89
Primary Endpoint
Grief Scale (GS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a prospective, single-arm, open-label study to assess the impact of the Family Connections (FC) program on various factors including burden, grief and several clinical variables (i.e., depressive symptoms, family functioning, alexithymia, global psychological distress and anger). It specifically targets caregivers of individuals diagnosed with Borderline Personality Disorder (BPD). The secondary aim of this research is to identify participant profiles that are more likely to experience improvements or deteriorations in their levels of burden and grief. In this study family members are consecutively recruited from four different Italian mental health services and undergo an assessment that includes the gathering of socio-demographic information and completing a comprehensive battery of self-report questionnaires at three specific time points (i.e., at baseline, at immediately post-intervention and at a 4-month follow-up).

Detailed Description

Borderline Personality Disorder (BPD) has a severe impact both on the lives of individuals with this disorder and those around them. Additionally, research indicates that the presence of an invalidating environment plays a crucial role in BPD's etiology. Caregivers of individuals with BPD and related conditions often experience higher levels of somatic and psychological distress compared to the general population. Moreover, the rate of objective and subjective burden on these caregivers is notably higher than that reported by family members of individuals with other mental disorders. One of the most well-established programs to support family members of patients with BPD is Family Connections (FC). The FC program is a 12-week manualized educational, skill-building, and support program based on the principles of Dialectical behavior therapy (DBT). Longitudinal studies showed significant improvements in various aspects, including reduced burden and grief, enhanced well-being and family functioning and decreased severity of depression. The primary objective of this study is to assess the impact of a 12-week FC program on grief and burden (primary outcomes) among family members of individuals with BPD. Secondary endpoints include measures of depression, alexithymia, global psychological distress, family functioning, and feelings of anger. The second aim of the study is to determine whether improvements in the primary outcomes (burden and grief scores) were predicted by variables such as age, gender and the other clinical variables. This intervention is administered in a group setting to family members of individuals with BPD. Each weekly session lasts 90 minutes and is led by two cognitive-behavioral therapists (a leader and a co-leader), both trained in the FC program and in DBT. Participants are recruited from one Italian mental health service, specifically IRCCS Centro San Giovanni di Dio Fatebenefratelli in Brescia. In 2018 the study was expanded to three additional Italian mental health centres (i.e., Dipartimento di Salute Mentale e delle Dipendenze, ASST del Garda, CPS di Leno; Fano Department of Mental Health in Fano and Mental Health Center in Albese con Cassano) through a protocol amendment, approved by the local Ethics Committee.

Registry
clinicaltrials.gov
Start Date
December 16, 2016
End Date
December 17, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Responsible Party
Principal Investigator
Principal Investigator

Roberta Rossi

psychologist, researcher, Head of the Unit of Psychiatry

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Eligibility Criteria

Inclusion Criteria

  • to be 18 years of age or older
  • to serve as a caregiver or significant other of an individual diagnosed with BPD
  • to provide written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Grief Scale (GS)

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.

Burden Assessment scale (BAS)

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 higher burden.

Secondary Outcomes

  • Symptom Check List-90 (SCL-90)(Baseline, immediately post-intervention, 4-month follow-up)
  • Toronto Alexithymia Scale 20 (TAS-20)(Baseline, immediately post-intervention, 4-month follow-up)
  • State Trait Anger Expression Inventory (STAXI-2)(Baseline, immediately post-intervention, 4-month follow-up)
  • Family Functioning Questionnaire (FFQ)(Baseline, immediately post-intervention, 4-month follow-up)
  • Beck Depression Inventory II (BDI-II)(Baseline, immediately post-intervention, 4-month follow-up)

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