Psychoeducative Treatment of FEP With Mobile Training

Psychosis Clinical Trial

Official title:

Psychoeducative Treatment of First Episode Psychosis With Mobile Training:Study Protocol for a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03161249
• Other study ID #: PsicoApp
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: International University of La Rioja
• Contact: Ana Calvo, PI
• Phone: +34941210211
• Email: anabcalv[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychological
• Psychosis
• Psychotic Disorders
• Therapy

Intervention

Behavioral:
• Experimental group
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)

Other:
• Control group
Group that does not receive any treatment added to its usual treatment

Locations

Country	Name	City	State
Spain	Ana Belén Calvo	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
International University of La Rioja

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in adherence	The adherence is measured using Morisky Medication Adherence Scale	Change from baseline adherence level at 3 months
Other	Change from baseline in quality of life	The quality of life is measured using the World Health Organization Quality of Life WHOQOL	Change from baseline quality of life at 3 months
Other	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
Primary	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
Secondary	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
Secondary	Change from Baseline in anxiety level	Anxiety is measured using the State-Trait Anxiety Inventory	Change from baseline anxiety symptoms at 3 months
Secondary	Change From Baseline in functionality	The functionality is measure using Children's Global Assessment Scale	Change from Baseline functionality at 3 months
Secondary	Change From Baseline in functionality II	The functionality is measure using Global Assessment of Functioning Scale	Change from baseline functionality at 3 months
Secondary	Change From Baseline in functionality III	The functionality is measure using Strauss Carpenter Rating Scale	Change from baseline functionality at 3 months
Secondary	Change from baseline in prognosis I	Number of relapses, hospitalizations and visits to the ER.	Change from baseline prognosis at 3 months
Secondary	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