Clinical trial NCT03161249: Psychoeducative Treatment of FEP With Mobile Training. ThinkApp
Official title: Psychoeducative Treatment of First Episode Psychosis With Mobile Training (ThinkApp):Study Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Psychological
Therapy
Keywords: first psychotic episode
mobile app intervention
Lead sponsor: International University of La Rioja
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 and 6 months follow-up. This randomized clinical trial includes blind evaluators.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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:

* Psychoeducative Module (12 sessions)
* Module of recognition of symptomatology and prevention of relapses
* Module Troubleshooting
* Mindfulness Module
* Module of social skills

Eligibility criteria: Inclusion Criteria:

* Age of the patient between 14-30 years
* The presence of at least 1 positive psychotic symptom (delusions or hallucinations) and 1 of the following diagnoses from DSM-5 (Apa., 2013): schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, major depressive disorder with psychotic features, brief psychotic disorder, or psychosis not otherwise specified.
* Be at least two months without presenting acute psychotic symptoms (delusions or hallucination).
* Written consent given by the patient, parents and / or legal representative.(n this case they must accept to participate both, minor and tutor, concretely, the minors since from the age of 14 also have to accept to participate. )
* Access to a smartphone

Exclusion Criteria:

* Abuse and dependence on toxicants (use is accepted).
* Presence of organic diseases of the central nervous system, mental retardation or generalized developmental disorders

Primary outcomes:
measure: Change from Baseline in psychotic symptoms
timeFrame: Change from Baseline psychotic symptoms at 3 months
Secondary outcomes:
measure: Change from Baseline in affective symptoms
timeFrame: Change from baseline affective symptoms at 3 months
measure: Change from Baseline in anxiety level
timeFrame: Change from baseline anxiety symptoms at 3 months
measure: Change From Baseline in functionality
timeFrame: Change from Baseline functionality at 3 months
measure: Change From Baseline in functionality II
timeFrame: Change from baseline functionality at 3 months
measure: Change From Baseline in functionality III
timeFrame: Change from baseline functionality at 3 months
measure: Change from baseline in prognosis I
timeFrame: Change from baseline prognosis at 3 months
measure: Change from baseline in drug´s use
timeFrame: Change from baseline drug´s use at 3 months
Other outcomes:
measure: Change from baseline in adherence
timeFrame: Change from baseline adherence level at 3 months
measure: Change from baseline in quality of life
timeFrame: Change from baseline quality of life at 3 months
measure: Change from baseline in quality of life II
timeFrame: Change from baseline quality of life at 3 months
Locations:
city: Madrid
country: Spain
facility: Ana Belén Calvo
Study officials:
affiliation: UNIR
name: Ana Calvo, PI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.