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

Primary Purpose

Relatives

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Family Connections program
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relatives focused on measuring borderline personality disorder, family connections, relatives, dbt, smartphone app, technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universitat Jaume I

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smartphone Application

Treatment As Usual

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)
Depression, Anxiety and Stress Scale (DASS) have 42 items about negative emotional symptoms (Lovibond & Lovibond, 1995). Lovibond & Lovinbod (1995) proposed that a part of these subscales for can become part of a short version creating a new questionnaire of 21 items. Items are rated on a 4-point Likert scale ranging from 0 (It did not happen to me) to 3 (It happened to me a lot or most of the time), and higher scores indicate worse symptoms of depression, anxiety or stress. DASS-21 showed fantastic factor structures. Regarding to the internal consistency, Cronbach's alphas were excellent for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) (Antony, Bieling, Cox, Enns & Swinson, 1998).
Family Empowerment (FES; Koren, DeChillo & Friesen, 1992)
Family Empowerment Scale (FES) consists of 34 items divided in three subscales: family, service system, and involvement in community that is refered to three ways of empowerment, attitudes, knowledge, and behaviors (Koren, DeChillo & Friesen, 1992). Items are rated on a scale of 1 (completely false) to 5 (totally true), and higher scores indicate a greater sense of empowerment. The psychometric properties are the following: regarding to the internal consistency of FES subscores, the coefficients ranged from .87 to .88 and validity and reliability are adequated (Koren, DeChillo & Friesen, 1992).
Resilience (CD-RISC; Connor & Davidson, 2003)
Connor-Davidson Resilience scale is a 25-item measure of resilience. Items are rated on a 5-point Likert scale ranging from 0 (absolutely not) to 4 (almost always) and the punctuation is based on how the participant has felt over the last month. Higher scores means greater resilience (Connor & Davidson, 2003). The CD-RISC authors reported acceptable test-retest reliability (r = 0.87) and strong internal consistency (α = .89) (Connor & Davidson, 2003).

Full Information

First Posted
January 17, 2022
Last Updated
February 17, 2022
Sponsor
Universitat Jaume I
Collaborators
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05215392
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I
Collaborators
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relatives
Keywords
borderline personality disorder, family connections, relatives, dbt, smartphone app, technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Efficacy Study
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone Application
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Family Connections program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)
Description
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).
Time Frame
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
Secondary Outcome Measure Information:
Title
Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)
Description
Depression, Anxiety and Stress Scale (DASS) have 42 items about negative emotional symptoms (Lovibond & Lovibond, 1995). Lovibond & Lovinbod (1995) proposed that a part of these subscales for can become part of a short version creating a new questionnaire of 21 items. Items are rated on a 4-point Likert scale ranging from 0 (It did not happen to me) to 3 (It happened to me a lot or most of the time), and higher scores indicate worse symptoms of depression, anxiety or stress. DASS-21 showed fantastic factor structures. Regarding to the internal consistency, Cronbach's alphas were excellent for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) (Antony, Bieling, Cox, Enns & Swinson, 1998).
Time Frame
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
Title
Family Empowerment (FES; Koren, DeChillo & Friesen, 1992)
Description
Family Empowerment Scale (FES) consists of 34 items divided in three subscales: family, service system, and involvement in community that is refered to three ways of empowerment, attitudes, knowledge, and behaviors (Koren, DeChillo & Friesen, 1992). Items are rated on a scale of 1 (completely false) to 5 (totally true), and higher scores indicate a greater sense of empowerment. The psychometric properties are the following: regarding to the internal consistency of FES subscores, the coefficients ranged from .87 to .88 and validity and reliability are adequated (Koren, DeChillo & Friesen, 1992).
Time Frame
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
Title
Resilience (CD-RISC; Connor & Davidson, 2003)
Description
Connor-Davidson Resilience scale is a 25-item measure of resilience. Items are rated on a 5-point Likert scale ranging from 0 (absolutely not) to 4 (almost always) and the punctuation is based on how the participant has felt over the last month. Higher scores means greater resilience (Connor & Davidson, 2003). The CD-RISC authors reported acceptable test-retest reliability (r = 0.87) and strong internal consistency (α = .89) (Connor & Davidson, 2003).
Time Frame
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
Other Pre-specified Outcome Measures:
Title
System Usability Scale (SUS; Brooke, 2013).
Description
It consists of 10 items measured with a Likert scale with five response options from Strongly agree to Strongly disagree. It is reliable (coefficient alpha of .91) and useful (Bangor, Kortum, & Miller, 2008).
Time Frame
Changes will be assessed immediately after the intervention (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Verónica Guillén Botella, Dr
Phone
963864386
Ext
4386
Email
vguillenbotella@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Azucena García Palacios, Dr
Phone
964387640
Ext
7640
Email
azucena@uji.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Fernández Felipe, PhD Student
Organizational Affiliation
Universitat Jaume I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diana Castilla López, Dr
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariví Navarro Haro, Dr
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Jaume I
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12071
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Verónica Guillén Botella, Dr
Phone
964864386
Ext
4386
Email
fernandi@uji.es
First Name & Middle Initial & Last Name & Degree
Azucena García Palacios, Dr
Phone
964387640
Ext
7640
Email
azucena@uji.es
First Name & Middle Initial & Last Name & Degree
Isabel Fernández Felipe, PhD Student
First Name & Middle Initial & Last Name & Degree
Diana Castilla López, Dr
First Name & Middle Initial & Last Name & Degree
Mariví Navarro Haro, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available after deidentification.
IPD Sharing Time Frame
The data will be available immediately following publication
IPD Sharing Access Criteria
The data will be available to anyone who wishes to access them
Citations:
PubMed Identifier
17257517
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.
Results Reference
result
PubMed Identifier
16013747
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.
Results Reference
result
PubMed Identifier
14979218
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.
Results Reference
result
PubMed Identifier
10668619
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.
Results Reference
result
PubMed Identifier
28861273
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.
Results Reference
result
PubMed Identifier
19590999
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.
Results Reference
result

Learn more about this trial

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

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