Borderline Personality DisorderNCT06076343
Integrated Intervention for Borderline Personality Disorder and Caregivers
A study testing DBT skills-training and Family Connections interventions in people with Borderline Personality Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
This is a prospective, single-arm, open-label study to assess the impact of a group intervention for patients with borderline personality disorder (BPD) and a psycho-educational intervention for their caregivers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- DBT skills-training and Family Connections interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- to be outpatient with a DBP diagnosis according to DSM5
- age between 18 and 50
- written informed consent
Who cannot join
- bipolar disorder, psychotic disorders, organic mental disorders, mental retardation, current substance dependence
- FC intervention:
- being 18 years of age or older
- serving as a caregiver or significant other of an individual diagnosed with BPD providing written consent
- to have a self-reported acute mental health condition interfering with group participation at that time
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, BS, 25125
About this study
Official title: An Integrated Approach to Treatment of People With Borderline Personality Disorder and Their Caregivers
This is a prospective, single-arm, open-label study to assess the impact of a group intervention for patients with borderline personality disorder (BPD) and a psycho-educational intervention for their caregivers. Once participants complete a comprehensive clinical assessment, the study involves the participation of those with a BPD diagnosis in Dialectical Behavior Therapy (DBT) skills training group, integrated with ongoing routine treatments. A battery of questionnaires is administered before and after the DBT skills training to assess emotion dysregulation, BPD symptoms severity and other clinical variables. Simultaneously, caregivers of individuals with BPD take part in the Family Connections (FC) program. This sub-study follows a previous pilot study conducted at the same centre. Family members complete assessment questionnaires at three different time points (i.e., at baseline, at immediately post-intervention and at a 4-month follow-up) in order to evaluate putative positive pre-post changes on burden, grief and other clinical variables. In order to explore biomarkers of BPD and stress-related neurobiological mechanisms, blood samples are collected from the BPD patient group at pre and post intervention. At baseline, a blood sample is also collected to identify stress-related biomarkers among family members.
Read the detailed description
Borderline Personality Disorder (BPD) has a severe impact on the lives of individuals with this disorder. Also caregivers of individuals with BPD and related conditions often experience higher levels of somatic and psychological distress. Dialectical Behavior Therapy (DBT) has been proven to be an effective treatment for BPD and it has been well documented that also the module of skills training is effective in the reduction of symptoms. Moreover, one of the most well-established programs to support family members of patients with BPD is Family Connections (FC). FC showed beneficial effects on severity of depression, well-being and family functioning. The aim of the present study is threefold: 1. To evaluate the implementation of a DBT skills training program as a complementary intervention in routine health care. 2. To assess pre-post changes resulting from a FC intervention in family members of individuals with BPD and to identify predictors of positive outcomes. 3. To explore potential biomarkers associated with BPD and stress-related neurobiological mechanisms among both BPD patients and their family members. Participants are recruited at the IRCCS Centro San Giovanni di Dio Fatebenefratelli in Brescia. For the DBT skills training, the primary outcome is the reduction of emotion dysregulation. Secondary outcomes encompass measures of depression, anxiety, alexithymia, global psychological distress, global functioning, impulsiveness, interpersonal problems and severity of BPD symptoms. In addition, socio-demographics, trauma history and the presence of non-suicidal self injury or suicide attempts are assessed. Within the FC group, primary endpoints are burden and grief scores, while secondary endpoints include measurements of depression, alexithymia, global psychological distress, family functioning, and feelings of anger. DBT skills training consists of 24 weekly sessions that incorporate two acceptance-oriented skills (mindfulness and distress tolerance) and two change-oriented skills (emotion regulation and interpersonal effectiveness). The FC program, on the other hand, is a 12-week manualized educational and skills-building support program rooted in the principles of DBT, administered in a group setting to family members of individuals with BPD. Group facilitators possess a medical or psychological professional background and have received training in both the DBT and FC programs. In addition to psychological assessments, the study involves the collection of blood samples from the BPD patient group (before and after the intervention). These samples are collected in order to identify potential biomarkers associated with BPD and treatment response, including levels of Brain-Derived Neurotrophic Factor (BDNF), expression of pro-inflammatory cytokines and anti-inflammatory cytokines, and C-reactive Protein levels. Furthermore, the study analyzes stress-related biomarkers such as cortisol levels and investigate epigenetic mechanisms through DNA and miRNA metilations analysis. In the FC group, a baseline blood sample is also collected to explore stress-related biomarkers.
- Conditions
- Borderline Personality Disorder
- Being tested
- DBT skills-training and Family Connections interventions
- Keywords
- borderline personality disorder, caregivers, dialectical behavior therapy, biomarkers, emotion dysregulation
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT skills-training and Family Connections interventionsBehavioural
DBT skills-training program includes four modules: 1. Mindufulness, 2. Distress Tolerance, 3. Emotion Regulation, 4. Interpersonal effectiveness.
FC program includes six modules: 1. Introduction, 2. Family Education, 3. Relationship Mindfulness Skills, 4. Family Environment Skills, 5. Validation Skills, 6. Problem Management Skills.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical behavior therapy/Family Connections | Experimental | Outpatients with a diagnosis of BPD will be assigned to DBT skills-training intervention (6-10 participants per group). Each DBT skills-training group will receive 24 sessions. Family members of people with BPD will be assigned to psychoeducational intervention. Each FC group (10-12 participants) will receive 12 sessions. Each session for BPD patients and for caregivers lasts 1.5 hours and it is conducted by a leader and a co-leader (two trained psychotherapists). Receives: Behavioral: DBT skills-training and Family Connections interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale (DERS) (DBT group)
Change in emotion dysregulation scores on the DERS scale (36 items). Total score of the DERS ranges from 36 to 180 with higher scores indicating higher difficulties in emotion dysregulation.
Measured: Baseline, immediately post-intervention
Burden Assessment Scale (BAS) (FC group)
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 stronger burden.
Measured: Baseline, immediately post-intervention, 4-month follow-up
Grief Scale (GS) (FC group)
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.
Measured: Baseline, immediately post-intervention, 4-month follow-up
Secondary outcomes (11)
Beck Depression Inventory II (BDI-II) (FC group and DBT group)
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).
Measured: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
Symptom Check List-90 (SCL-90) (FC group and DBT group)
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.
Measured: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
Toronto Alexithymia Scale 20 (TAS-20) (FC group and DBT group)
Change in alexithymia scores. TAS-20 scoring range: 20-100 (higher scores indicating greater impairment in identifying and describing emotions).
Measured: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
State Trait Anger Expression Inventory (STAXI-2) (FC group and DBT group)
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).
Measured: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
Family Functioning Questionnaire (FFQ) (FC group)
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).
Measured: Baseline, immediately post-intervention, 4-month follow-up
Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) (DBT group)
Change in frequency of adaptive and maladaptive skills. DBT-WCCL is a 59-item self-report measure of skills used in response to difficult situations over the past month. Two subscales are included: DBT skills use and dysfunctional coping that are rated on a scale of 0-3. Higher score indicates more frequent use of adaptive coping strategies.
Measured: Baseline, immediately post-intervention
Zanarini Rating scale for BPD (DBT group)
Change in overall BPD symptoms severity scores. Zanarini Rating scale for BPD total score ranges from 0 to 36, with higher scores indicating greater severity.
Measured: Baseline, immediately post-intervention
Childhood Trauma Questionnaire short form (CTQ-SF) (DBT group)
Assessment of child maltreatment experiences scores. CTQ is a questionnaire consisting of 28 items, of which 25 measure childhood maltreatment. Total scores for the CTQ-SF range from 25 to 125 with higher scores indicating higher maltreatment severity.
Measured: Baseline
Barratt Impulsiveness Scale-11 (BIS-11) (DBT group)
Change in impulsiveness scores. BIS-11 is a 30-item self-report measure of impulsiveness. Total score ranges from 30 to 120. Higher scores reflecting higher levels of impulsiveness.
Measured: Baseline, immediately post-intervention
Inventory of Interpersonal Problems (IIP-47) (DBT group)
Change in interpersonal functioning scores. The IIP-PD-47 questionnaire is a self-report measure comprised of 47 items on a 5-point Likert scale (higher score reflecting higher interpersonal difficulties).
Measured: Baseline, immediately post-intervention
Attachment Style Questionnaire (ASQ) (DBT group)
Assessment of adult attachment styles. ASQ is a 40-item self-report measure assessing five attachment dimensions, and is answered on a 6-point Likert scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 May 2019
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- consecutive recruitment
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Rossi, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Roberta Rossi, psychologist, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076343
- Sponsor's protocol ID
- Integrated interventions
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.
PubMed 22581157McMain SF, Links PS, Gnam WH, Guimond T, Cardish RJ, Korman L, Streiner DL. A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1365-74. doi: 10.1176/appi.ajp.2009.09010039. Epub 2009 Sep 15.
PubMed 19755574Hoffman 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.
PubMed 16013747Liljedahl SI, Kleindienst N, Wangby-Lundh M, Lundh LG, Daukantaite D, Fruzzetti AE, Westling S. Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study. Borderline Personal Disord Emot Dysregul. 2019 Aug 26;6:14. doi: 10.1186/s40479-019-0111-6. eCollection 2019.
PubMed 31463066Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.
PubMed 25806661Lanfredi 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.
PubMed 39873150
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Approach to Treatment of People With Borderline Personality Disorder and Their Caregivers
- ClinicalTrials.gov ID
- NCT06076343
- Acronym / sponsor ID
- Integrated interventions
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, caregivers, dialectical behavior therapy, biomarkers, emotion dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, open-label study to assess the impact of a group intervention for patients with borderline personality disorder (BPD) and a psycho-educational intervention for their caregivers. Once participants complete a comprehensive clinical assessment, the study involves the participation of those with a BPD diagnosis in Dialectical Behavior Therapy (DBT) skills training group, integrated with ongoing routine treatments. A battery of questionnaires is administered before and after the DBT skills training to assess emotion dysregulation, BPD symptoms severity and other clinical variables. Simultaneously, caregivers of individuals with BPD take part in the Family Connections (FC) program. This sub-study follows a previous pilot study conducted at the same centre. Family members complete assessment questionnaires at three different time points (i.e., at baseline, at immediately post-intervention and at a 4-month follow-up) in order to evaluate putative positive pre-post changes on burden, grief and other clinical variables. In order to explore biomarkers of BPD and stress-related neurobiological mechanisms, blood samples are collected from the BPD patient group at pre and post intervention. At baseline, a blood sample is also collected to identify stress-related biomarkers among family members.
Detailed description
Borderline Personality Disorder (BPD) has a severe impact on the lives of individuals with this disorder. Also caregivers of individuals with BPD and related conditions often experience higher levels of somatic and psychological distress. Dialectical Behavior Therapy (DBT) has been proven to be an effective treatment for BPD and it has been well documented that also the module of skills training is effective in the reduction of symptoms. Moreover, one of the most well-established programs to support family members of patients with BPD is Family Connections (FC). FC showed beneficial effects on severity of depression, well-being and family functioning. The aim of the present study is threefold: 1. To evaluate the implementation of a DBT skills training program as a complementary intervention in routine health care. 2. To assess pre-post changes resulting from a FC intervention in family members of individuals with BPD and to identify predictors of positive outcomes. 3. To explore potential biomarkers associated with BPD and stress-related neurobiological mechanisms among both BPD patients and their family members. Participants are recruited at the IRCCS Centro San Giovanni di Dio Fatebenefratelli in Brescia. For the DBT skills training, the primary outcome is the reduction of emotion dysregulation. Secondary outcomes encompass measures of depression, anxiety, alexithymia, global psychological distress, global functioning, impulsiveness, interpersonal problems and severity of BPD symptoms. In addition, socio-demographics, trauma history and the presence of non-suicidal self injury or suicide attempts are assessed. Within the FC group, primary endpoints are burden and grief scores, while secondary endpoints include measurements of depression, alexithymia, global psychological distress, family functioning, and feelings of anger. DBT skills training consists of 24 weekly sessions that incorporate two acceptance-oriented skills (mindfulness and distress tolerance) and two change-oriented skills (emotion regulation and interpersonal effectiveness). The FC program, on the other hand, is a 12-week manualized educational and skills-building support program rooted in the principles of DBT, administered in a group setting to family members of individuals with BPD. Group facilitators possess a medical or psychological professional background and have received training in both the DBT and FC programs. In addition to psychological assessments, the study involves the collection of blood samples from the BPD patient group (before and after the intervention). These samples are collected in order to identify potential biomarkers associated with BPD and treatment response, including levels of Brain-Derived Neurotrophic Factor (BDNF), expression of pro-inflammatory cytokines and anti-inflammatory cytokines, and C-reactive Protein levels. Furthermore, the study analyzes stress-related biomarkers such as cortisol levels and investigate epigenetic mechanisms through DNA and miRNA metilations analysis. In the FC group, a baseline blood sample is also collected to explore stress-related biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- consecutive recruitment
| Arm | Type | Receives |
|---|---|---|
| Dialectical behavior therapy/Family Connections | Experimental | Behavioral: DBT skills-training and Family Connections interventionsOutpatients with a diagnosis of BPD will be assigned to DBT skills-training intervention (6-10 participants per group). Each DBT skills-training group will receive 24 sessions. Family members of people with BPD will be assigned to psychoeducational intervention. Each FC group (10-12 participants) will receive 12 sessions. Each session for BPD patients and for caregivers lasts 1.5 hours and it is conducted by a leader and a co-leader (two trained psychotherapists). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- to be outpatient with a DBP diagnosis according to DSM5
- age between 18 and 50
- written informed consent
Key exclusion criteria (5 listed)
- bipolar disorder, psychotic disorders, organic mental disorders, mental retardation, current substance dependence
- being 18 years of age or older
- serving as a caregiver or significant other of an individual diagnosed with BPD providing written consent
- to have a self-reported acute mental health condition interfering with group participation at that time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT skills-training and Family Connections interventionsDBT skills-training program includes four modules: 1. Mindufulness, 2. Distress Tolerance, 3. Emotion Regulation, 4. Interpersonal effectiveness. FC program includes six modules: 1. Introduction, 2. Family Education, 3. Relationship Mindfulness Skills, 4. Family Environment Skills, 5. Validation Skills, 6. Problem Management Skills. | Behavioural | Dialectical behavior therapy/Family Connections |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS) (DBT group)
Time frame: Baseline, immediately post-intervention
Change in emotion dysregulation scores on the DERS scale (36 items). Total score of the DERS ranges from 36 to 180 with higher scores indicating higher difficulties in emotion dysregulation.
Burden Assessment Scale (BAS) (FC group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up
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 stronger burden.
Grief Scale (GS) (FC group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up
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.
11 secondary outcomes
Beck Depression Inventory II (BDI-II) (FC group and DBT group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
Symptom Check List-90 (SCL-90) (FC group and DBT group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
Toronto Alexithymia Scale 20 (TAS-20) (FC group and DBT group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
State Trait Anger Expression Inventory (STAXI-2) (FC group and DBT group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)
Family Functioning Questionnaire (FFQ) (FC group)
Time frame: Baseline, immediately post-intervention, 4-month follow-up
Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) (DBT group)
Time frame: Baseline, immediately post-intervention
Zanarini Rating scale for BPD (DBT group)
Time frame: Baseline, immediately post-intervention
Childhood Trauma Questionnaire short form (CTQ-SF) (DBT group)
Time frame: Baseline
Barratt Impulsiveness Scale-11 (BIS-11) (DBT group)
Time frame: Baseline, immediately post-intervention
Inventory of Interpersonal Problems (IIP-47) (DBT group)
Time frame: Baseline, immediately post-intervention
Attachment Style Questionnaire (ASQ) (DBT group)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 22581157McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.
- Background: PubMed 19755574McMain SF, Links PS, Gnam WH, Guimond T, Cardish RJ, Korman L, Streiner DL. A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1365-74. doi: 10.1176/appi.ajp.2009.09010039. Epub 2009 Sep 15.
- Background: PubMed 16013747Hoffman 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.
- Background: PubMed 31463066Liljedahl SI, Kleindienst N, Wangby-Lundh M, Lundh LG, Daukantaite D, Fruzzetti AE, Westling S. Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study. Borderline Personal Disord Emot Dysregul. 2019 Aug 26;6:14. doi: 10.1186/s40479-019-0111-6. eCollection 2019.
- Background: PubMed 25806661Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.
- Derived from this study: PubMed 39873150Lanfredi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta Rossi, psychologist principal investigator
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT skills-training and Family Connections interventions in people with Borderline Personality Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale (DERS) (DBT group) (time frame: Baseline, immediately post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076343, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.