Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Psychological
  • Psychosis
  • Therapy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an experimental, randomized and longitudinal study of repeated measures with independent groups (Treatment group or experimental group: EG and control group: CG) which includes pre and post treatment. This randomized clinical trial includes blind evaluators.Masking: Single (Investigator)Masking Description: blind evaluatorsPrimary Purpose: Treatment

Participation Requirements

Age
Between 14 years and 19 years
Gender
Both males and females

Description

Clinical assessment criteria Data on the major clinical and demographic variables are entered in a data collection form. All patients are assessed at baseline and have been or will be assessed at 3 months after inclusion in the study. All the instruments used in the study have demonstrated appropria...

Clinical assessment criteria Data on the major clinical and demographic variables are entered in a data collection form. All patients are assessed at baseline and have been or will be assessed at 3 months after inclusion in the study. All the instruments used in the study have demonstrated appropriate psychometric properties, and were used in many studies Demographic data Data are collected on age, sex, level of education, living arrangements and employment or educational status. Assessment of psychotic symptoms are assessed using the Positive and Negative Syndrome Scale. The scale for the assessment of positive symptoms and negative symptoms. Trait and state anxiety will be measured using the State-Trait Anxiety Inventory. The mood is evaluated using the Hamilton Rating Scale for Depression. We measure patient insight into their illness using the Scale to Assess Unawareness of Mental Disorders. We use the Strauss and Carpenter Prognostic Scale. We also assess the overall function of patients using a Spanish version of the Global Assessment of Functioning Scale. The level of functioning was measured using the Children's Global Assessment Scale. We measure this variable using the "Morisky" Medication Adherence Scale. We measure patient functional status using the Functioning Assessment Short Test. The consumption is measured using the ASI (Addition severity index) scale. The quality of life is measured using the World Health Organization Quality of Life WHOQOL-BREF Questionnaire .In addition, we assess quality of life using the EuroQoL questionnaire. Mobile Application Android Mobile app with a web support and administration application, along with a cloud based backend database, which will register fine-grain interactions between the users and the app, in order to make possible the generation of relevant granular data and key performance indicators to support a wide range of further analysis. This application will be designed and developed using Software Engineering-based Agile Methodologies, under SCRUM principles (empiric control of the development process, using continuous feedback processes). The whole mobile app functionality and its user interfaces and interactions will be designed under the premises of maximizing the User experience, as a factor contributing to the adherence of users to the treatment. On the security side, all of the communications between the mobile app and the supporting backend will be protected by means of a "SSL" digital certificate on the server, providing end to end encrypted communications Data Management For security, all data introduce in database will have an internal code, and will be checked by another data manager, in order to guarantee the data security. Intervention programme Mobile phone App treatment The psychoeducational app programme is composed of 5 modules: Psychoeducative Module (12 sessions) Module of recognition of symptomatology and prevention of relapses Module Troubleshooting Mindfulness Module Module of social skills

Tracking Information

NCT #
NCT03161249
Collaborators
Not Provided
Investigators
Principal Investigator: Ana Calvo, PI UNIR