"Family Connections": a Program for Relatives of People With Borderline Personality Disorder

NCT04160871 | Unknown DMC

• 1 other identifier: UJaumeI19-1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Relatives

Keywords

borderline personality disorder; family connections; relatives; dbt; intervention; program; caregivers

Outcome Measures

Primary Outcomes (2)

• Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992).

  Burden Assessment Scale (BAS) consists of 19 items and it assess the caregivers' objective and subjective burden within the past six months. Items are rated on a 4-point Likert scale ranging from 1(nothing) to 4 (a lot), and higher values indicate stronger burden. Internal reliability of the scale ranged from .89 to .91 and it shows adequated validity (Reinhard, Gubman, Horwitz \& Minsky, 1994).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983).

  Family Assessment Device - Global Functioning Scale (FAD-GFS) is a self-report questionnaire (Epstein, Baldwin \& Bishop, 1983). It consists of 60 items about family functioning. It is composed of seven subscales: Problem-Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behavior Control and General Functioning. Items are rated on a 4-point Likert scale ranging from 1 (totally agree) to 4 (totally disagree), and higher scores indicate unhealthy functioning. Cronbach's alphas ranges from .72 to .83 for the subscales and general functioning is .92 (Miller, Epstein, Bishop \& Keitner, 1985) and test-retest for the FAD scales were adequate (Miller, Epstein, Bishop \& Keitner, 1985).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

Secondary Outcomes (9)

• Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Family Empowerment Scale (FES; Koren, DeChillo & Friesen, 1992).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Quality of Life Index-Spanish Version (QLI-Sp; Mezzich, Cohen, Ruipérez & Yoon, 1999).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

Other Outcomes (6)

• Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

• Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

Study Arms (2)

Family Connections

EXPERIMENTAL

Experimental group

Behavioral: Family Connections

Treatment As Usual

ACTIVE COMPARATOR

Control group

Behavioral: Treatment As Usual

Interventions

Family Connections BEHAVIORAL

Intervention includes 12 sessions that follow a group format of 2 hours with a weekly frequency. FC program (Hoffman and Fruzzetti, 2005) is divided into six modules: 1: Updated information and research on BPD; 2: Psychoeducation on the development of BPD, available treatments and comorbidity; 3: Individual skills: self-control of emotions, mindfulness, reality acceptance skills, validation skills, etc. and skills of relationship to promote emotional well-being problem management (family skills); 4: Family skills to improve the quality of relationships in family interactions; 5: Communication skills and effective self-expression; and 6: Problem management. All modules include Practice exercises and homework. In addition, throughout the program, in order to increase social support, the FC program provides a forum where participants can stay in touch, share common problems and solutions.

Family Connections

Treatment As Usual BEHAVIORAL

The intervention lasts for 3 months and includes 12 sessions that follow a group format of 2 hours and with a weekly frequency. It includes the following components: Psychoeducation about personality disorders and, specifically, BPD and how these disorders evolve. Problems associated with BPD (eg, alcohol and / or drug use, eating disorders, etc.). The importance of "modeling" in family members: change of attitude towards difficult situations to reduce the escalation of tension and re-establish a healthy relationship between the patient and family. The handling of problems. Crisis management: Development of safe plans for when the patient is in emotional escalation.

Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Jaume I: lead
• University of Valencia: collaborator

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 17257517 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

• 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.

  PMID: 14979218 BACKGROUND

• 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.

  PMID: 10668619 BACKGROUND

• 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.

  PMID: 28861273 BACKGROUND

• 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.

  PMID: 19590999 BACKGROUND

• Guillen V, Bolo S, Fonseca-Baeza S, Perez S, Garcia-Alandete J, Botella C, Marco JH. Psychological assessment of parents of people diagnosed with borderline personality disorder and comparison with parents of people without psychological disorders. Front Psychol. 2023 Jan 13;13:1097959. doi: 10.3389/fpsyg.2022.1097959. eCollection 2022.

  PMID: 36710828 DERIVED

• 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.

  PMID: 32539740 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Maple syrup urine disease, type 2

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• José Heliodoro Marco Salvador, Dr

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Isabel Fernández Felipe, PhD student

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Amanda Díaz García, Dr

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Cristina Botella Arbona, Dr

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Verónica Guillén Botella, Dr

CONTACT

963864386; vguillenbotella@gmail.com

Azucena García Palacios, Dr

CONTACT

964387640; azucena@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Efficacy Study.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: November 15, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available immediately following publication.
• Access Criteria: The data will be available to anyone who wishes to access them.

Locations

ES (1)