Clinical trial NCT04160871: "Family Connections": a Program for Relatives of People With Borderline Personality Disorder
Official title: Efficacy of "Family Connections", a Program for Relatives of People With Borderline Personality Disorder in Spanish Population: A Study Protocol for a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relatives
Keywords: borderline personality disorder
family connections
relatives
dbt
intervention
program
caregivers
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2019-11-13
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Efficacy Study.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to validate an intervention for relatives of people with borderline personality disorder in Spanish population in a randomized control trial.

Detailed description: Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. It consists of 12 sessions with an approximate duration of two hours each. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. The investigators have translated and adapted the program so that it could be applied to the Spanish population. The aim of the present study is to evaluate the effectiveness of the adaptation of "Family connections" in Spanish population through a controlled clinical trial. The first hypothesis of the study is that "Family Connections" will be more effective (significant reduction in the primary outcome variables), compared with a Treatment As Usual (TAU), in the posttest time and in the follow-ups of 3 and 6 months. In addition, a second hypothesis is that "Family Connections" will be more efficient (fewer abandonments, better opinion on the part of the patients) than TAU.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Having a relative with DSM-5 diagnosis of Personality Disorder
* Understand spoken and written Spanish.
* Grant informed consent.

Exclusion Criteria:

* Diagnosis of severe mental disorder.
* Presence of medical illness that may interfere with psychological treatment.
* Suicide risk.

Primary outcomes:
measure: Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Family Empowerment Scale (FES; Koren, DeChillo & Friesen, 1992).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Quality of Life Index-Spanish Version (QLI-Sp; Mezzich, Cohen, Ruipérez & Yoon, 1999).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Beck Hopelessness Scale (BHS; Beck, Weissman, Lester & Trexler, 1974).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Openness To the Future Scale (OFS; Botella et al., 2018).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Personality Inventory for DSM-5 (PID-5; Krueger, Derringer, Markon, Watson & Skodol, 2012).
timeFrame: Pre-treatment
measure: Structured Clinical Interview for DSM-IV Axis II (SCID-II; First, Gibbon, Spitzer, Williams & Benjamin, 1997).
timeFrame: Pre-treatment
Other outcomes:
measure: Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Lum Emotional Availability of Parents (LEAP; Lum & Phares, 2005).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Validating and Invalidating Responses Scale (VIRS; Fruzzetti, 2007).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
measure: Post-Module measures (P-M)
timeFrame: Immediately after the intervention
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: University of Valencia
name: José Heliodoro Marco Salvador, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Isabel Fernández Felipe, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Amanda Díaz García, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Cristina Botella Arbona, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffman PD, Fruzzetti AE. Advances in interventions for families with a relative with a personality disorder diagnosis. Curr Psychiatry Rep. 2007 Feb;9(1):68-73. doi: 10.1007/s11920-007-0012-z.
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.
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, Swenson CR. Dialectical behavior therapy--family skills training. Fam Process. 1999 Winter;38(4):399-414. doi: 10.1111/j.1545-5300.1999.00399.x.
citation: Flynn D, Kells M, Joyce M, Corcoran P, Herley S, Suarez C, Cotter P, Hurley J, Weihrauch M, Groeger J. Family Connections versus optimised treatment-as-usual for family members of individuals with borderline personality disorder: non-randomised controlled study. Borderline Personal Disord Emot Dysregul. 2017 Aug 30;4:18. doi: 10.1186/s40479-017-0069-1. eCollection 2017.
citation: Rajalin M, Wickholm-Pethrus L, Hursti T, Jokinen J. Dialectical behavior therapy-based skills training for family members of suicide attempters. Arch Suicide Res. 2009;13(3):257-63. doi: 10.1080/13811110903044401.
citation: Fernandez-Felipe I, Guillen V, Marco H, Diaz-Garcia A, Botella C, Jorquera M, Banos R, Garcia-Palacios A. Efficacy of "Family Connections", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial. BMC Psychiatry. 2020 Jun 15;20(1):302. doi: 10.1186/s12888-020-02708-8.