A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.
17. februar 2022 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
116
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Verónica Guillén Botella, Dr
- Telefonnummer: 4386 963864386
- E-post: vguillenbotella@gmail.com
Studer Kontakt Backup
- Navn: Azucena García Palacios, Dr
- Telefonnummer: 7640 964387640
- E-post: azucena@uji.es
Studiesteder
-
-
Castellón
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Castellón De La Plana, Castellón, Spania, 12071
- Universitat Jaume I
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Ta kontakt med:
- Azucena García Palacios, Dr
- Telefonnummer: 7640 964387640
- E-post: azucena@uji.es
-
Hovedetterforsker:
- Isabel Fernández Felipe, PhD Student
-
Ta kontakt med:
- Verónica Guillén Botella, Dr
- Telefonnummer: 4386 964864386
- E-post: fernandi@uji.es
-
Hovedetterforsker:
- Diana Castilla López, Dr
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Hovedetterforsker:
- Mariví Navarro Haro, Dr
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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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.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Isabel Fernández Felipe, PhD Student, Universitat Jaume I
- Hovedetterforsker: Diana Castilla López, Dr, University of Valencia
- Hovedetterforsker: Mariví Navarro Haro, Dr, Universidad de Zaragoza
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. september 2022
Primær fullføring (Forventet)
31. desember 2022
Studiet fullført (Forventet)
15. januar 2023
Datoer for studieregistrering
Først innsendt
17. januar 2022
Først innsendt som oppfylte QC-kriteriene
17. januar 2022
Først lagt ut (Faktiske)
31. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UJaumeI22-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Individual participant data will be available after deidentification.
IPD-delingstidsramme
The data will be available immediately following publication
Tilgangskriterier for IPD-deling
The data will be available to anyone who wishes to access them
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .