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

NCT06074289 | Completed DMC

• 1 other identifier: Family Connections
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Family Caregivers

Keywords

caregivers; burden; grief; dialectical behavior therapy

Outcome Measures

Primary Outcomes (2)

• Burden Assessment scale (BAS)

  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.

  Baseline, immediately post-intervention, 4-month follow-up

• Grief Scale (GS)

  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.

  Baseline, immediately post-intervention, 4-month follow-up

Secondary Outcomes (5)

• Beck Depression Inventory II (BDI-II)

  Baseline, immediately post-intervention, 4-month follow-up

• 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

Study Arms (1)

Family connections program

EXPERIMENTAL

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

Behavioral: Family connections program

Interventions

Family connections program 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.

Family connections program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Como, Italy: collaborator
• Department of Mental Health - ASUR Marche AV1: collaborator
• Fondazione Comunità Bresciana: collaborator
• Azienda Socio Sanitaria Territoriale del Garda: collaborator

Related Publications (3)

• 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.

  PMID: 14979218 BACKGROUND

• 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.

  PMID: 16013747 BACKGROUND

• 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.

  PMID: 39873150 DERIVED

Study Officials

• Roberta Rossi, psychologist

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: psychologist, researcher, Head of the Unit of Psychiatry

Model Details: consecutive sampling

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 10, 2023
• Study Start: December 16, 2016
• Primary Completion: December 10, 2018
• Study Completion: December 17, 2018
• Last Updated: October 12, 2023

Record last verified: 2023-10