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

NCT ID: NCT04160871

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2020-09-30

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.

Conditions

Relatives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Family Connections

Experimental group

Group Type: EXPERIMENTAL

Family Connections

Intervention Type: 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.

Treatment As Usual

Control group

Group Type: ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type: 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.

Interventions

Family Connections

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.

Intervention Type: BEHAVIORAL

Treatment As Usual

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: collaborator

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Heliodoro Marco Salvador, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Isabel Fernández Felipe, PhD student

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Amanda Díaz García, Dr

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Cristina Botella Arbona, Dr

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Locations

Universitat Jaume I

Castellon, Castellón, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Verónica Guillén Botella, Dr

Role: CONTACT

vguillenbotella@gmail.com

963864386 ext. 4386

Azucena García Palacios, Dr

Role: CONTACT

azucena@uji.es

964387640 ext. 7640

Facility Contacts

Verónica Guillén Botella, Dr

Role: primary

vguillenbotella@gmail.com

963864386 ext. 4386

Azucena García Palacios, Dr

Role: backup

azucena@uji.es

964387640 ext. 7640

References

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.

Reference Type: BACKGROUND

PMID: 17257517 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16013747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14979218 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10668619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28861273 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19590999 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36710828 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32539740 (View on PubMed)

Other Identifiers

UJaumeI19-1

Identifier Type: -

Identifier Source: org_study_id