A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.

NCT ID: NCT05215392

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-15

Brief Summary

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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

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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.

Conditions

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Relatives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Efficacy Study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double (Participant, Investigator)

Study Groups

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Smartphone Application

Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an ecological momentary assessment (EMA) via the Family Connections smartphone app.

Group Type EXPERIMENTAL

Family Connections program

Intervention Type BEHAVIORAL

Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an ecological momentary assessment (EMA) via the Family Connections smartphone app. Family members in this condition will receive the manual of Family Connections which contains all the information on the program sessions conducted and the skills training strategies in writing.

Treatment As Usual

Family members in this condition will receive the manual of Family Connections which contains all the information on the program sessions conducted and the skills training strategies in writing.

Group Type ACTIVE_COMPARATOR

Family Connections program

Intervention Type BEHAVIORAL

Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an ecological momentary assessment (EMA) via the Family Connections smartphone app. Family members in this condition will receive the manual of Family Connections which contains all the information on the program sessions conducted and the skills training strategies in writing.

Interventions

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Family Connections program

Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an ecological momentary assessment (EMA) via the Family Connections smartphone app. Family members in this condition will receive the manual of Family Connections which contains all the information on the program sessions conducted and the skills training strategies in writing.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role collaborator

Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel Fernández Felipe, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Diana Castilla López, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Mariví Navarro Haro, Dr

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

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Universitat Jaume I

Castellon, Castellón, Spain

Site Status

Countries

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Spain

Central Contacts

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Verónica Guillén Botella, Dr

Role: CONTACT

963864386 ext. 4386

Azucena García Palacios, Dr

Role: CONTACT

964387640 ext. 7640

Facility Contacts

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Verónica Guillén Botella, Dr

Role: primary

964864386 ext. 4386

Azucena García Palacios, Dr

Role: backup

964387640 ext. 7640

References

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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 RESULT
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 RESULT
PMID: 19590999 (View on PubMed)

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 RESULT
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 RESULT
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 RESULT
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 RESULT
PMID: 10668619 (View on PubMed)

Other Identifiers

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UJaumeI22-1

Identifier Type: -

Identifier Source: org_study_id

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