A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.
17 de febrero de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
116
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Verónica Guillén Botella, Dr
- Número de teléfono: 4386 963864386
- Correo electrónico: vguillenbotella@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Azucena García Palacios, Dr
- Número de teléfono: 7640 964387640
- Correo electrónico: azucena@uji.es
Ubicaciones de estudio
-
-
Castellón
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Castellón De La Plana, Castellón, España, 12071
- Universitat Jaume I
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Contacto:
- Azucena García Palacios, Dr
- Número de teléfono: 7640 964387640
- Correo electrónico: azucena@uji.es
-
Investigador principal:
- Isabel Fernández Felipe, PhD Student
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Contacto:
- Verónica Guillén Botella, Dr
- Número de teléfono: 4386 964864386
- Correo electrónico: fernandi@uji.es
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Investigador principal:
- Diana Castilla López, Dr
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Investigador principal:
- Mariví Navarro Haro, Dr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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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Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)
Periodo de tiempo: 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).
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Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)
Periodo de tiempo: 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).
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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)
Periodo de tiempo: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
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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).
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Changes will be assessed from pre-treatment to immediately after the intervention (3 months)
|
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Resilience (CD-RISC; Connor & Davidson, 2003)
Periodo de tiempo: 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)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
System Usability Scale (SUS; Brooke, 2013).
Periodo de tiempo: 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).
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Changes will be assessed immediately after the intervention (3 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Isabel Fernández Felipe, PhD Student, Universitat Jaume I
- Investigador principal: Diana Castilla López, Dr, University of Valencia
- Investigador principal: Mariví Navarro Haro, Dr, Universidad de Zaragoza
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de septiembre de 2022
Finalización primaria (Anticipado)
31 de diciembre de 2022
Finalización del estudio (Anticipado)
15 de enero de 2023
Fechas de registro del estudio
Enviado por primera vez
17 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
17 de enero de 2022
Publicado por primera vez (Actual)
31 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
17 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UJaumeI22-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data will be available after deidentification.
Marco de tiempo para compartir IPD
The data will be available immediately following publication
Criterios de acceso compartido de IPD
The data will be available to anyone who wishes to access them
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .