Clinical trial NCT05215392: A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.
Official title: A Smartphone Application of "Family Connections" to Increase the Use of Skills and the Improving of Psychological Symptoms in Relatives of People With Borderline Personality Disorder: a Protocol Study for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relatives
Keywords: borderline personality disorder
family connections
relatives
dbt
smartphone app
technology
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2022-01-31
Enrollment: 116
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 aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.

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. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. Two of the technologies with very promising developments are Ecological Momentary Assessment and Ecological Momentary Intervention, that can act on each other. A large number of smartphone apps for people with psychological problems focus on the provision of instructions, adaptive self-help strategies, alarms, electronic diaries or emotional state ratings. The Family Connections app proposed in this article consists of a smartphone app built using EMA and EMI technologies.The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.

Eligibility criteria: Inclusion Criteria:

* Having a family member diagnosed with borderline personality disorder.
* Being 18 years of age or older.
* Knowing and understanding the Spanish language.
* Having a smartphone with Internet connection.
* Completing the informed consent.

Primary outcomes:
measure: Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
Secondary outcomes:
measure: Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
measure: Family Empowerment (FES; Koren, DeChillo & Friesen, 1992)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
measure: Resilience (CD-RISC; Connor & Davidson, 2003)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
Other outcomes:
measure: System Usability Scale (SUS; Brooke, 2013).
timeFrame: Changes will be assessed immediately after the intervention (3 months)
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: Universitat Jaume I
name: Isabel Fernández Felipe, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Diana Castilla López, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Zaragoza
name: Mariví Navarro Haro, 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.