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
About this trial
This is an interventional treatment trial for Family Caregivers focused on measuring caregivers, burden, grief, dialectical behavior therapy
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
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
NCT ID
NCT06074289
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
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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