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eMotiph: E-mental Health Solution for Patients With Schizophrenia

G

Grupo Pulso

Status

Completed

Conditions

Schizophrenia

Treatments

Device: eMotiph

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05345977
12470-2

Details and patient eligibility

About

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).

Full description

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.

Enrollment

7 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Unified Protocol
Experimental group
Description:
The psychotherapy Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
Treatment:
Device: eMotiph

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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