PsychosisNCT03161249
Psychoeducative Treatment of FEP With Mobile Training. ThinkApp
A study testing Experimental group in people with Psychosis and Psychological, run by International University of La Rioja at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Psychosis, Psychological, Therapy
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Abuse and dependence on toxicants (use is accepted).
- Presence of organic diseases of the central nervous system, mental retardation or generalized developmental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychoeducative Treatment of First Episode Psychosis With Mobile Training (ThinkApp):Study Protocol for a Randomised Controlled Trial
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.
Read the 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
- Conditions
- Psychosis, Psychological, Therapy
- Being tested
- Experimental group, Control group
- Keywords
- first psychotic episode, mobile app intervention
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Also called Psychotherapy group (5 modules)
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)
Control groupOther
Also called Control group, or treatment as usual group
Group that does not receive any treatment added to its usual treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Mobile psychotherapy (5 modules) plus treatment as usual Receives: 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 Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in psychotic symptoms
Assessment of psychotic symptoms are assessed using the Positive and Negative Syndrome Scale
Measured: Change from Baseline psychotic symptoms at 3 months
Secondary outcomes (7)
Change from Baseline in affective symptoms
The mood was evaluated using the Hamilton Rating Scale for Depression
Measured: Change from baseline affective symptoms at 3 months
Change from Baseline in anxiety level
Anxiety is measured using the State-Trait Anxiety Inventory
Measured: Change from baseline anxiety symptoms at 3 months
Change From Baseline in functionality
The functionality is measure using Children's Global Assessment Scale
Measured: Change from Baseline functionality at 3 months
Change From Baseline in functionality II
The functionality is measure using Global Assessment of Functioning Scale
Measured: Change from baseline functionality at 3 months
Change From Baseline in functionality III
The functionality is measure using Strauss Carpenter Rating Scale
Measured: Change from baseline functionality at 3 months
Change from baseline in prognosis I
Number of relapses, hospitalizations and visits to the ER.
Measured: Change from baseline prognosis at 3 months
Change from baseline in drug´s use
The consumption is measured using the ASI (ASI-6 scale)
Measured: Change from baseline drug´s use at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jun 2020
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- International University of La Rioja
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Calvo, PI, Principal investigator, UNIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161249
- Sponsor's protocol ID
- PsicoApp
- Status last verified
- May 2025
- First submitted
- 2 May 2017
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30804818
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducative Treatment of First Episode Psychosis With Mobile Training (ThinkApp):Study Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03161249
- Acronym / sponsor ID
- PsicoApp
- Conditions
- Psychosis, Psychological, Therapy
- Keywords
- first psychotic episode, mobile app intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- International University of La RiojaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Experimental groupMobile psychotherapy (5 modules) plus treatment as usual |
| Control group | Other | Other: Control groupControl 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 |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Abuse and dependence on toxicants (use is accepted).
- Presence of organic diseases of the central nervous system, mental retardation or generalized developmental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupAlso: Psychotherapy group (5 modules)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) | Behavioural | Experimental group |
| Control groupAlso: Control group, or treatment as usual groupGroup that does not receive any treatment added to its usual treatment | Other | Control group |
Primary outcome
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
7 secondary outcomes
Change from Baseline in affective symptoms
Time frame: Change from baseline affective symptoms at 3 months
Change from Baseline in anxiety level
Time frame: Change from baseline anxiety symptoms at 3 months
Change From Baseline in functionality
Time frame: Change from Baseline functionality at 3 months
Change From Baseline in functionality II
Time frame: Change from baseline functionality at 3 months
Change From Baseline in functionality III
Time frame: Change from baseline functionality at 3 months
Change from baseline in prognosis I
Time frame: Change from baseline prognosis at 3 months
Change from baseline in drug´s use
Time frame: Change from baseline drug´s use at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Derived from this study: PubMed 30804818Barbeito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Calvo, PI principal investigator
UNIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Psychosis and Psychological, run by International University of La Rioja at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in psychotic symptoms (time frame: Change from Baseline psychotic symptoms at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.