eMotiph: E-mental Health Solution for Patients With Schizophrenia

NCT05345977 | Completed

• 1 other identifier: 12470-2
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Schizophrenia

Keywords

mHealth; Treatment resistent schizophrenia

Outcome Measures

Primary Outcomes (3)

• Technology Acceptance Model Scale (TAM)

  Degree of acceptance of the digital solution and the intervention delivered. The scale provides scores in 8 dimensions: Perceived Usefulness (score ranges from 5 to 35), Perceived Ease of Use (score ranges from 6 to 42), Attitude (score ranges from 2 to 14), Facilitators (score ranges from 4 to 28), Barriers (score ranges from 2 to 14), Subjective Norm (score ranges from 3 to 21), Intention to Use (score ranges from 1 to 7) and Habits (score ranges from 2 to 14). As much the response trend is located in the positive pole for most of the items, higher acceptability.

  Data will be collected immediately after the intervention.

• User experience questionnaire

  A questionnaire ad hoc will be created where the degree of usability and lived experience after using the digital solution will be measured. This scale has not cut off points. Higher values mean higher usability.

  Data will be collected immediately after the intervention

• Client Satisfaction Questionnaire (CSQ-8)

  The opinions and conclusions about the digital solution delivered will be asked. The scale has not cut off points. Higher values mean higher satisfaction.

  Data will be collected immediately after the intervention

Secondary Outcomes (27)

• Positive and Negative Syndrome Scale (PANSS)

  Change from Baseline Positive and Negative Syndrome Scale at 6 months.

• Calgary Depresion Scale for Schizophrenia (CDS)

  Change from Baseline Calgary Depresion Scale for Schizophrenia at 6 months.

• Beck Anxiety Inventory (BAI)

  Change from Baseline Beck Anxiety Inventory at 6 months.

• Clinical Global Impression (CGI)

  Change from Baseline Clinical Global Impression at 6 months.

• NEO Five-Factor Inventory

  Change from Baseline NEO Five-Factor Inventory at 6 months.

Study Arms (1)

Unified Protocol

EXPERIMENTAL

The psychotherapy Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.

Device: eMotiph

Interventions

eMotiph DEVICE

Mobile application for patients with schizophrenia.

Unified Protocol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Pulso: lead
• Hospital de Sant Pau: collaborator
• Nurogames GmbH: collaborator
• Fundació Tic Salut i Social: collaborator

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (1)

• Grasa E, Forment A, Alonso-Solis A, Ramalho L, Roldan A, Pousa E, Ausso S, Berdun J, Genova Tesoro A, Escudero J, Corripio I. Defining the Patient Journey and Identifying Digital Health Solutions in Treatment-Resistant Schizophrenia. Actas Esp Psiquiatr. 2025 Dec;53(6):1208-1222. doi: 10.62641/aep.v53i6.1959.

  PMID: 41437755 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Iluminada Corripio, PhD

  Hospital de Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective non-randomised feasibility trial

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 26, 2022
• Study Start: June 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

ES (1)