The Impact of a Psycho-educational Program for Family Members of Individuals With Borderline Personality Disorder

NCT ID: NCT06074289

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-16
• Study Completion Date: 2018-12-17

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.

Conditions

Family Caregivers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family connections program

In each centre, caregivers are consecutively assigned to a group intervention including from 10 to 12 participants.

Group Type: EXPERIMENTAL

Family connections program

Intervention Type: BEHAVIORAL

Caregivers meet weekly for 90 minute sessions led by two trained psychologists. The 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

Family connections program

Caregivers meet weekly for 90 minute sessions led by two trained psychologists. The 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Como, Italy

UNKNOWN

Sponsor Role: collaborator

Department of Mental Health - ASUR Marche AV1

UNKNOWN

Sponsor Role: collaborator

Fondazione Comunità Bresciana

UNKNOWN

Sponsor Role: collaborator

Azienda Socio Sanitaria Territoriale del Garda

OTHER_GOV

Sponsor Role: collaborator

IRCCS Centro San Giovanni di Dio Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Roberta Rossi

psychologist, researcher, Head of the Unit of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberta Rossi, psychologist

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

References

Hoffman PD, Buteau E, Hooley JM, Fruzzetti AE, Bruce ML. Family members' knowledge about borderline personality disorder: correspondence with their levels of depression, burden, distress, and expressed emotion. Fam Process. 2003 Winter;42(4):469-78. doi: 10.1111/j.1545-5300.2003.00469.x.

Reference Type: BACKGROUND

PMID: 14979218 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16013747 (View on PubMed)

Lanfredi M, Meloni S, Ferrari C, Fruzzetti AE, Geviti A, Macis A, Vanni G, Perna G, Diaferia G, Pinti M, Occhialini G, Ridolfi ME, Rossi R. Family Connections: The Impact of an Education Program for Carers of Individuals With Borderline Personality Disorder in Italian Mental Health Services. Fam Process. 2025 Mar;64(1):e13098. doi: 10.1111/famp.13098.

Reference Type: DERIVED

PMID: 39873150 (View on PubMed)

Other Identifiers

Family Connections

Identifier Type: -

Identifier Source: org_study_id