Psychoeducative Treatment of FEP With Mobile Training. ThinkApp

NCT03161249 | Completed

• 1 other identifier: PsicoApp
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Psychological; Therapy

Keywords

first psychotic episode; mobile app intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from Baseline in affective symptoms

  Change from baseline affective symptoms at 3 months

• Change from Baseline in anxiety level

  Change from baseline anxiety symptoms at 3 months

• Change From Baseline in functionality

  Change from Baseline functionality at 3 months

• Change From Baseline in functionality II

  Change from baseline functionality at 3 months

• Change From Baseline in functionality III

  Change from baseline functionality at 3 months

Other Outcomes (3)

• Change from baseline in adherence

  Change from baseline adherence level at 3 months

• Change from baseline in quality of life

  Change from baseline quality of life at 3 months

• Change from baseline in quality of life II

  Change from baseline quality of life at 3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Mobile psychotherapy (5 modules) plus treatment as usual

Behavioral: Experimental group

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

Other: Control group

Interventions

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)

Also known as: Psychotherapy group (5 modules)

Experimental group

Control group OTHER

Group that does not receive any treatment added to its usual treatment

Also known as: Control group, or treatment as usual group

Control group

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• International University of La Rioja: lead

Study Sites (1)

Ana Belén Calvo

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 30804818 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Psychotherapy, Group; Control Groups; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ana Calvo, PI

  UNIR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: blind evaluators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 19, 2017
• Study Start: June 1, 2020
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)