Clinical trial NCT06074289: The Impact of a Psycho-educational Program for Family Members of Individuals With Borderline Personality Disorder
Official title: Psycho-educational Program for Family Members of People With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Keywords: caregivers
burden
grief
dialectical behavior therapy
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Como, Italy
name: Department of Mental Health - ASUR Marche AV1
name: Fondazione Comunità Bresciana
name: Azienda Socio Sanitaria Territoriale del Garda
First posted: 2023-10-10
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: consecutive sampling
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Burden Assessment scale (BAS)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: Grief Scale (GS)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
Secondary outcomes:
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: Symptom Check List-90 (SCL-90)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: Toronto Alexithymia Scale 20 (TAS-20)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: State Trait Anger Expression Inventory (STAXI-2)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
measure: Family Functioning Questionnaire (FFQ)
timeFrame: Baseline, immediately post-intervention, 4-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
name: Roberta Rossi, psychologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.