eMotiph: E-mental Health Solution for Patients With Schizophrenia

NCT ID: NCT05345977

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-02-28

Brief Summary

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Although the main objective of current schizophrenia intervention programs is the reduction of symptoms, its rates are around 36%, and recovery rates are 16.5%. Between 30 and 50% of people with schizophrenia obtain little benefit with conventional therapy. They are considered resistant to treatment. Therefore, the development of innovative evidence-based interventions adjunctive to pharmacological and psychological treatment are necessary for improving results in patients with treatment-resistant schizophrenia (TRS). Studies with digital solutions have shown feasibility, acceptability and even preliminary efficacy data. But no earlier published study has focused on TRS.

The eMOTIPH is an innovative solution addressed to TRS and born from the outcomes of the previous study eMOTIPH Part 1 (study of beliefs, needs, and limitations associated with current intervention in TRS patients).

Detailed Description

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A prospective non-randomised feasibility trial will be performed. People with a diagnosis of treatment-resistant schizophrenia and their informal caregivers will test the digital mental health solution eMOTIPH for 6 months. Psychiatric treatment and psychological intervention (based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Farchione et al., 2012) will be delivered to patients.

The aim of the study is to evaluate the feasibility, acceptability, usability, satisfaction and perceived quality of life after using the eMOTIPH digital solution.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective non-randomised feasibility trial
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Unified Protocol

The psychotherapy Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.

Group Type EXPERIMENTAL

eMotiph

Intervention Type DEVICE

Mobile application for patients with schizophrenia.

Interventions

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eMotiph

Mobile application for patients with schizophrenia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age between 18-55 years old.
* Diagnosis of schizophrenia following the Diagnostic and Statistical Manual of Mental Disorders-5 criteria.
* Meet criteria for treatment-resistant schizophrenia.
* Used to information and communication technology and with the physical capability to use them.

Exclusion Criteria

* Meet criteria for remission according to the Remission of Schizophrenia Working Group (Andreasen et al., 2005).
* The presence of delusions mainly related to their therapists or with new technologies.
* Hearing, vision or motor impairment that makes it impossible to operate a smartphone.
* Intellectual Developmental Disability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Sant Pau

OTHER

Sponsor Role collaborator

Nurogames GmbH

UNKNOWN

Sponsor Role collaborator

Fundació Tic Salut i Social

UNKNOWN

Sponsor Role collaborator

Grupo Pulso

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iluminada Corripio, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sant Pau

Locations

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Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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12470-2

Identifier Type: -

Identifier Source: org_study_id

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