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INTERSTRESSINTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Coping skills and relaxation training with new technologies

+ Traditional coping skills and relaxation training

Conductual
Quiénes están siendo reclutados

De 25 a 60 años
+7 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: mayo de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalIstituto Auxologico Italiano
Última actualización: 29 de agosto de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de mayo de 2012

Fecha en la que se inscribió al primer participante.

The present trial is based on a randomized controlled study. We will recruited at least 100 participants, that will be split into two groups of at least 50 subjects who suffer from psychological stress: 1) the experimental group 2) the control group. Participants included in the experimental condition will receive a treatment based on cognitive behavioral techniques combined to virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as qualitative dependent variable. Different settings are planned for the training: Clinical, Home and Mobile Setting. Following, a description of the protocol in details, both for the experimental and the control group, in the three different settings. 1) In the experimental condition, participants will first take part to an intake session with the introduction to the training (clinical setting) and to an assessment week to detect stressful situations in daily life through portable biosensors and a smart phone (home setting); then they will be exposed to an assessment session for detecting the psycho-physiological variations occurred during the different stressful environments exposure (clinical setting). Afterwards, participants will receive a training for psychological stress management based on cognitive behavioral techniques combined to virtual reality, biofeedback and mobile phone. The training will be structured into ten sessions (two per week, each one lasting about one hour), which will be divided into four parts: homework checking exposition to a stressful scenario and following cognitive restructuring with the clinician relaxation home assignment During the training, biosensors will be worn to monitor physiological parameters, to track the emotional/heath status and to directly influence experience in the virtual world. Relaxation will be induced through the immersion in different virtual environments (e.g., lake) which will be customized with different pre-recorded audio narratives that describe the specific setting and that guide the execution of a series of relaxation exercises. Experimental group will be exposed both to relaxing VR environments and to VR biofeedback, in alternate way during sessions. 18-months follow up is planned in order to verify the efficacy of the training over a long-term period. 2) In the control condition, participants will receive a training based on a protocol with the same structure of the experimental group's one, without the use of new technologies and biofeedback. In particular, guided imagery will be employed as a stress exposition and for relaxation exercises. The smart phone for stress assessment will be replaced by a traditional diary, where to mark stressful event during the assessment week. In order to obtain comparable measures with the experimental group, participants in the control condition will be assessed during the training with the same questionnaires and their physiological measures will be recorded during each session. As to home setting, instead of Second Life participants will receive a book about psychological stress, with the same contents included in that virtual island.18-months follow up is planned in order to verify the efficacy of the training over a long-term period.

NCT01683617
Patrocinador PrincipalIstituto Auxologico Italiano
Última actualización: 29 de agosto de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 100 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 25 a 60 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

2 criterios de inclusión requeridos para participar
Age between 25 and 60 years

Individual who suffer from psychological stress

5 criterios de exclusión impiden participar
DSM_IV-TR Axis I disorders

history of neurological diseases, mental retardation, psychosis, alcohol or drug dependence

migraine, headache, or vestibular abnormalities

pharmacotherapy received for their psychological stress

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Individuals will receive a treatment based on cognitive behavioral therapy and new technologies (virtual reality, virtual reality combined to biofeedback and mobile phones). Relaxation will be induced through the immersion in different virtual environments (e.g., lake) which will be customized with different pre-recorded audio narratives that describe the specific setting and that guide the execution of a series of relaxation exercises. During biofeedback exercises a wearable biosensor system will provide suggestions to the trainer based on the reactions of the participants, and the biosensor data will directly modify the virtual reality experience in real time.

Grupo II

Comparador Activo
Participants will receive a treatment based on traditional cognitive behavioral therapy techniques for stress management, without the use of new technologies. Relaxation will be induced by guided imagery, through auditory narratives.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Istituto Auxologico Italiano

Milan, ItalyAbrir Istituto Auxologico Italiano en Google Maps
Completado1 Centros de Estudio