- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02316158
PsYoungSupport - Web-based Support to Young Careers to Persons With Mental Illness (PSYS)
PsYoungSupport Internet and Communication Technology Based Health Programmes - Information, Education and Support to Young People Close to Persons With Mental Illness
The overall aim with the project PsYoungSupport is to evaluate Internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults (16-25 years) who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention.
The participatory design is one of the foundations of this project, and young adult participants will be consulted through out the research project. PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The aim of phase III is to evaluate the effect of an internet based intervention containing information, education and support for young adults in families where a family member suffers from mental illness or functional disability. The participants (N=400) will be randomised to two groups with different kinds of support. The participants will be evaluated using self-questionnaires and web interviews at the following occasions: baseline at the start of the intervention, after 4 months and after 8 months. This project will have implications for persons suffering from mental illness as well as for their relatives and close friends.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In the last decades it has been stated that the mental health of young people has deteriorated. Nowadays, the main part of the psychiatric care are out-patient care, family, relatives and close friends get involved and needs to take large responsibility for their relative or friend with mental illness. Therefore it is important to acquire knowledge that could benefit the patients and their families. There is still a gap in the knowledge as to which social support, such as information and education processes, are of value to the patient and family struggling with depression, and as to how individuals benefits from these components in their functional recovery from depression. Accordingly, pedagogic processes as an integrated part of patient-centred care and treatment may be increasingly important to study.
The overall aim is to evaluate internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention.
PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The investigators have a participatory design, including young persons in the whole research process. Primary outcome measures are social interaction, the degree of subjective and objective burden, stigmatisation and illness. Data are going to be based on both qualitative and quantitative approaches. The results are also going to evaluate cost effectiveness and the process of learning.
Within three years this project will describe different kind of implications for relatives and close friends who are caring for persons suffering from mental illness. Increased accessibility to knowledge about how mental health can benefit them and their relatives and close friends will facilitate for and empower these persons, and also increase their participation in society and with that increase the democracy for these persons in the society. Within five years this study can be integrated within the Swedish national website Care on line.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Göteborg, Suecia, 405 30
- Vårdalinstitutet - The Swedish Institute for Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age 16-25 years
- seeing themselves as a relative or close friend who supports a person with mental illness
Exclusion Criteria:
- persons who do not understand, read or express him-/herself in Swedish
- persons with acute severe mental illness or acute suicidal risk
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Webb-based support and education
It contains of two parts 1) evidence based information (about mental diseases, early signs, coping strategies, what you can do for your relative or close friend, what you can do for yourself, addresses to networks and web sites, relevant juridical issues, etc), 2) FAQ, where you directly can find answers to common questions.
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Comparison between the efficacy between webb-based support and informational support
Otros nombres:
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Comparador activo: Available support in society
Available support in society for young persons presented in a brochure
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Comparison between the efficacy between webb-based support and informational support
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Decreased change in Burden
Periodo de tiempo: 8 months
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Cope Index (McKee, Philp, Lamura et al 2003.
The Cope Index measures components such as negative effect of caring, positive values and the quality of support aspects of supporting a relative or close friend.
Each question is answered on a 4-point scale with the alternative 'never' ,'sometimes', 'often' and 'always'.
Some questions have the alternative of 'not applicable'.
All scores are added within each area and high scores indicate a high level of negative effect, positive value and quality of support.
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8 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Decreased Stress
Periodo de tiempo: Eight months
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Perceived Stress Scale (Cohen Kamch, Meremelstein, 1983).
Measures the degree to which situations in individuals' daily life are appraised as stressful.
The questions cover how the informant felt and thought during the last month.
The questionaire consist of 10 items and each item is answered on a 5-point scale 0=never; 1=almost never; 2=sometimes; 3=faily often and 5=very often.
PSS scores are obtained by reversing responses (e.g., 0=4; 1=3; 2=2; 3=1 and 4=0 to the 4 positively stated items (items 4,5,7 & 8) and then summing across all scale items
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Eight months
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Ingela Skärsäter, PhD, University of Gothenburg, 405 30 Göteborg, Sweden
- Investigador principal: Barbro Krevers, PhD, Linköping University, 581 83 Linköping, Sweden
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A2007003
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