Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the effectiveness of an online intervention through a mobile application, specifically designed for adolescents with a First Psychotic Episode (FEP), as a complement to the pharmacological and therapeutic interventions they receive at their referral center (Treatment as usual). To do this, a longitudinal study will be carried out on patients with FEP and between the ages of 14 and 30, who come to the Child and Adolescent Psychiatry Service of the General Universitarian Hospital "Gregorio Marañón", Psychiatry Department of the Ramon y Cajal Hospital in Madrid and Psychiatry Department of San Joan de Déu in Catalonia. Adolescents and young will be randomly assigned to an experimental group, where they will receive standard treatment plus online intervention, or a control group, where they will receive standard treatment.
This online intervention, the continuation of the work of this same team researcher in the "PIENSA program", aims to address little of the more traditional treatments and treatments such as community functioning, quality of life or affective symptoms. In addition, it will increase disease awareness, which will lead to greater adherence to treatment and fewer relapses and rehospitalizations.
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 and at 6 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/Ios 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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Mobile psychotherapy (5 modules) plus treatment as usual |
|
| Control group | Other | Control group: Treatment as usual The description of this group, the control group, corresponds to the treatment to receive the usual treatment that is received on a regular basis, we will not perform any additional intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group | Behavioral | The experimental group receiving mobile treatment: treatment as usual plus a psychotherapy intervention by the telephone app (a total of 5 modules of psychotherapy: psychoeducation plus mindfulness plus alerts plus social wall plus problems solving) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in psychotic symptoms | Assessment of psychotic symptoms are assessed using the Positive and Negative Syndrome Scale | Change from Baseline psychotic symptoms at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in affective symptoms | The mood was evaluated using the Hamilton Rating Scale for Depression | Change from baseline affective symptoms at 3 months |
| Change from Baseline in anxiety level |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in adherence | The adherence is measured using Morisky Medication Adherence Scale | Change from baseline adherence level at 3 months |
| Change from baseline in quality of life | The quality of life is measured using the World Health Organization Quality of Life WHOQOL |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Calvo, PI | UNIR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana Belén Calvo | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30804818 | Derived | Barbeito S, Sanchez-Gutierrez T, Mayoral M, Moreno M, Rios-Aguilar S, Arango C, Calvo A. Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial. Front Psychiatry. 2019 Feb 5;10:27. doi: 10.3389/fpsyt.2019.00027. eCollection 2019. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| D035061 | Control Groups |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D015340 | Epidemiologic Research Design |
Not provided
Not provided
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 and 6 months follow-up. This randomized clinical trial includes blind evaluators.
Not provided
Not provided
blind evaluators
|
|
| Control group | Other | Group that does not receive any treatment added to its usual treatment |
|
|
Anxiety is measured using the State-Trait Anxiety Inventory
| Change from baseline anxiety symptoms at 3 months |
| Change From Baseline in functionality | The functionality is measure using Children's Global Assessment Scale | Change from Baseline functionality at 3 months |
| Change From Baseline in functionality II | The functionality is measure using Global Assessment of Functioning Scale | Change from baseline functionality at 3 months |
| Change From Baseline in functionality III | The functionality is measure using Strauss Carpenter Rating Scale | Change from baseline functionality at 3 months |
| Change from baseline in prognosis I | Number of relapses, hospitalizations and visits to the ER. | Change from baseline prognosis at 3 months |
| Change from baseline in drug´s use | The consumption is measured using the ASI (ASI-6 scale) | Change from baseline drug´s use at 3 months |
| Change from baseline quality of life at 3 months |
| Change from baseline in quality of life II | The quality of life is measured using EuroQoL scale | Change from baseline quality of life at 3 months |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |