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

Primary Purpose

Family Caregivers

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family connections program
Sponsored by
IRCCS Centro San Giovanni di Dio Fatebenefratelli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family Caregivers focused on measuring caregivers, burden, grief, dialectical behavior therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Family connections program

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Beck Depression Inventory II (BDI-II)
    Change in depressive symptoms scores. The BDI-II is evaluated on a severity scale ranging from 0-3, with a total score ranging from 0-63 (higher scores reflecting higher levels of depression).
    Symptom Check List-90 (SCL-90)
    Change in the global severity index score of the SCL-90 questionnaire. SCL-90 total scores range from 90-360 with higher scores indicating higher psychological problems.
    Toronto Alexithymia Scale 20 (TAS-20)
    Change in alexithymia scores. TAS-20 scoring range: 20-100 (higher scores indicating greater impairment in identifying and describing emotions).
    State Trait Anger Expression Inventory (STAXI-2)
    Change in anger severity scores as measured with two subscales of the State Trait Anger Expression Inventory (STAXI-2): 1. the Anger Expression-Out (STAXI-2 ER/OUT) sub-scale measures the frequency in the expression of feelings of anger verbally or physically (range 8-32); 2. the Anger Expression-In (STAXI-2 ER/IN) measures how often the participant experiences anger and suppresses it or withholds it instead of expressing it (range 8-32).
    Family Functioning Questionnaire (FFQ)
    Change in family functioning scores. The FFQ is a 24-item questionnaire with higher scores indicating greater occurrence of positive family related behaviors (total score ranges from 24 to 96).

    Full Information

    First Posted
    September 29, 2023
    Last Updated
    October 10, 2023
    Sponsor
    IRCCS Centro San Giovanni di Dio Fatebenefratelli
    Collaborators
    Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Como, Italy, Department of Mental Health - ASUR Marche AV1, Fondazione Comunità Bresciana, Azienda Socio Sanitaria Territoriale del Garda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06074289
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 16, 2016 (Actual)
    Primary Completion Date
    December 10, 2018 (Actual)
    Study Completion Date
    December 17, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IRCCS Centro San Giovanni di Dio Fatebenefratelli
    Collaborators
    Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Como, Italy, Department of Mental Health - ASUR Marche AV1, Fondazione Comunità Bresciana, Azienda Socio Sanitaria Territoriale del Garda

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Family Caregivers
    Keywords
    caregivers, burden, grief, dialectical behavior therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    consecutive sampling
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Family connections program
    Arm Type
    Experimental
    Arm Description
    In each centre, caregivers are consecutively assigned to a group intervention including from 10 to 12 participants.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family connections program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Burden Assessment scale (BAS)
    Description
    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.
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up
    Title
    Grief Scale (GS)
    Description
    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.
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up
    Secondary Outcome Measure Information:
    Title
    Beck Depression Inventory II (BDI-II)
    Description
    Change in depressive symptoms scores. The BDI-II is evaluated on a severity scale ranging from 0-3, with a total score ranging from 0-63 (higher scores reflecting higher levels of depression).
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up
    Title
    Symptom Check List-90 (SCL-90)
    Description
    Change in the global severity index score of the SCL-90 questionnaire. SCL-90 total scores range from 90-360 with higher scores indicating higher psychological problems.
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up
    Title
    Toronto Alexithymia Scale 20 (TAS-20)
    Description
    Change in alexithymia scores. TAS-20 scoring range: 20-100 (higher scores indicating greater impairment in identifying and describing emotions).
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up
    Title
    State Trait Anger Expression Inventory (STAXI-2)
    Description
    Change in anger severity scores as measured with two subscales of the State Trait Anger Expression Inventory (STAXI-2): 1. the Anger Expression-Out (STAXI-2 ER/OUT) sub-scale measures the frequency in the expression of feelings of anger verbally or physically (range 8-32); 2. the Anger Expression-In (STAXI-2 ER/IN) measures how often the participant experiences anger and suppresses it or withholds it instead of expressing it (range 8-32).
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up
    Title
    Family Functioning Questionnaire (FFQ)
    Description
    Change in family functioning scores. The FFQ is a 24-item questionnaire with higher scores indicating greater occurrence of positive family related behaviors (total score ranges from 24 to 96).
    Time Frame
    Baseline, immediately post-intervention, 4-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roberta Rossi, psychologist
    Organizational Affiliation
    IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14979218
    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.
    Results Reference
    background
    PubMed Identifier
    16013747
    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.
    Results Reference
    background

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

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