Integrated Intervention for Borderline Personality Disorder and Caregivers

NCT06076343 | Completed DMC

• 1 other identifier: Integrated interventions
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Borderline Personality Disorder

Keywords

borderline personality disorder; caregivers; dialectical behavior therapy; biomarkers; emotion dysregulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (11)

• Beck Depression Inventory II (BDI-II) (FC group and DBT group)

  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)

  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)

  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)

  Baseline, immediately post-intervention, 4-month follow-up (FC group). Baseline, immediately post-intervention (DBT group)

• Family Functioning Questionnaire (FFQ) (FC group)

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

Study Arms (1)

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).

Behavioral: DBT skills-training and Family Connections interventions

Interventions

DBT skills-training and Family Connections interventions BEHAVIORAL

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.

Dialectical behavior therapy/Family Connections

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to be outpatient with a DBP diagnosis according to DSM5
• age between 18 and 50
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (1)

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, BS, 25125, Italy

Location

Related Publications (6)

• 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.

  PMID: 22581157 BACKGROUND

• McMain 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.

  PMID: 19755574 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

• Liljedahl 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.

  PMID: 31463066 BACKGROUND

• Linehan 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.

  PMID: 25806661 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

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

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: Principal investigator

Model Details: consecutive recruitment

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 10, 2023
• Study Start: May 15, 2019
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

IT (1)