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Psychoeducative Treatment of FEP With Mobile Training

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ClinicalTrials.gov Identifier: NCT03161249
Recruitment Status : Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
International University of La Rioja

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 19, who come to the Child and Adolescent Psychiatry Service of the General Universitarian Hospital "Gregorio Marañón" in Madrid. Adolescents 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.


Condition or disease Intervention/treatment Phase
Psychosis Psychology, Social Therapy Behavioral: Experimental group Other: Control group Not Applicable

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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. This randomized clinical trial includes blind evaluators.
Masking: Single (Investigator)
Masking Description: blind evaluators
Primary Purpose: Treatment
Official Title: Psychoeducative Treatment of First Episode Psychosis With Mobile Training:Study Protocol for a Randomised Controlled Trial
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Mobile psychotherapy (5 modules) plus treatment as usual
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 Name: Psychotherapy group (5 modules)

Control group

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
Group that does not receive any treatment added to its usual treatment
Other Name: Control group, or treatment as usual group




Primary Outcome Measures :
  1. Change from Baseline in psychotic symptoms [ Time Frame: Change from Baseline psychotic symptoms at 3 months ]
    Assessment of psychotic symptoms are assessed using the Positive and Negative Syndrome Scale


Secondary Outcome Measures :
  1. Change from Baseline in affective symptoms [ Time Frame: Change from baseline affective symptoms at 3 months ]
    The mood was evaluated using the Hamilton Rating Scale for Depression

  2. Change from Baseline in anxiety level [ Time Frame: Change from baseline anxiety symptoms at 3 months ]
    Anxiety is measured using the State-Trait Anxiety Inventory

  3. Change From Baseline in functionality [ Time Frame: Change from Baseline functionality at 3 months ]
    The functionality is measure using Children's Global Assessment Scale

  4. Change From Baseline in functionality II [ Time Frame: Change from baseline functionality at 3 months ]
    The functionality is measure using Global Assessment of Functioning Scale

  5. Change From Baseline in functionality III [ Time Frame: Change from baseline functionality at 3 months ]
    The functionality is measure using Strauss Carpenter Rating Scale

  6. Change from baseline in prognosis I [ Time Frame: Change from baseline prognosis at 3 months ]
    Number of relapses, hospitalizations and visits to the ER.

  7. Change from baseline in drug´s use [ Time Frame: Change from baseline drug´s use at 3 months ]
    The consumption is measured using the ASI (ASI-6 scale)


Other Outcome Measures:
  1. Change from baseline in adherence [ Time Frame: Change from baseline adherence level at 3 months ]
    The adherence is measured using Morisky Medication Adherence Scale

  2. Change from baseline in quality of life [ Time Frame: Change from baseline quality of life at 3 months ]
    The quality of life is measured using the World Health Organization Quality of Life WHOQOL

  3. Change from baseline in quality of life II [ Time Frame: Change from baseline quality of life at 3 months ]
    The quality of life is measured using EuroQoL scale



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of the patient between 14-19 years
  • The presence of at least 1 positive psychotic symptom (delusions or hallucinations) before age 19 years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161249


Contacts
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Contact: Ana Calvo, PI 941210211 anabelen.calvo@unir.net

Sponsors and Collaborators
International University of La Rioja
Investigators
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Principal Investigator: Ana Calvo, PI UNIR

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International University of La Rioja
ClinicalTrials.gov Identifier: NCT03161249     History of Changes
Other Study ID Numbers: PsicoApp
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by International University of La Rioja:
first psychotic episode, mobile app intervention

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders