A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.
17. februar 2022 opdateret af: Universitat Jaume I
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.
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
116
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Verónica Guillén Botella, Dr
- Telefonnummer: 4386 963864386
- E-mail: vguillenbotella@gmail.com
Undersøgelse Kontakt Backup
- Navn: Azucena García Palacios, Dr
- Telefonnummer: 7640 964387640
- E-mail: azucena@uji.es
Studiesteder
-
-
Castellón
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Castellón De La Plana, Castellón, Spanien, 12071
- Universitat Jaume I
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Kontakt:
- Azucena García Palacios, Dr
- Telefonnummer: 7640 964387640
- E-mail: azucena@uji.es
-
Ledende efterforsker:
- Isabel Fernández Felipe, PhD Student
-
Kontakt:
- Verónica Guillén Botella, Dr
- Telefonnummer: 4386 964864386
- E-mail: fernandi@uji.es
-
Ledende efterforsker:
- Diana Castilla López, Dr
-
Ledende efterforsker:
- Mariví Navarro Haro, Dr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)
Tidsramme: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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 (3 months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)
Tidsramme: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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).
|
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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Family Empowerment (FES; Koren, DeChillo & Friesen, 1992)
Tidsramme: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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).
|
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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Resilience (CD-RISC; Connor & Davidson, 2003)
Tidsramme: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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).
|
Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
System Usability Scale (SUS; Brooke, 2013).
Tidsramme: Changes will be assessed immediately after the intervention (3 months)
|
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).
|
Changes will be assessed immediately after the intervention (3 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Isabel Fernández Felipe, PhD Student, Universitat Jaume I
- Ledende efterforsker: Diana Castilla López, Dr, University of Valencia
- Ledende efterforsker: Mariví Navarro Haro, Dr, Universidad de Zaragoza
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. september 2022
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
15. januar 2023
Datoer for studieregistrering
Først indsendt
17. januar 2022
Først indsendt, der opfyldte QC-kriterier
17. januar 2022
Først opslået (Faktiske)
31. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UJaumeI22-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Individual participant data will be available after deidentification.
IPD-delingstidsramme
The data will be available immediately following publication
IPD-delingsadgangskriterier
The data will be available to anyone who wishes to access them
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
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