Clinical trial NCT05345977: eMotiph: E-mental Health Solution for Patients With Schizophrenia
Official title: eMotiph: Smart and Innovative E-mental Health Solution to Manage Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: mHealth
Treatment resistent schizophrenia
Lead sponsor: Grupo Pulso
Sponsor class: INDUSTRY
Collaborators: name: Hospital de Sant Pau
name: Nurogames GmbH
name: Fundació Tic Salut i Social
First posted: 2022-04-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective non-randomised feasibility trial
Primary purpose: DEVICE_FEASIBILITY

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technology Acceptance Model Scale (TAM)
timeFrame: Data will be collected immediately after the intervention.
measure: User experience questionnaire
timeFrame: Data will be collected immediately after the intervention
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Data will be collected immediately after the intervention
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from Baseline Positive and Negative Syndrome Scale at 6 months.
measure: Calgary Depresion Scale for Schizophrenia (CDS)
timeFrame: Change from Baseline Calgary Depresion Scale for Schizophrenia at 6 months.
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from Baseline Beck Anxiety Inventory at 6 months.
measure: Clinical Global Impression (CGI)
timeFrame: Change from Baseline Clinical Global Impression at 6 months.
measure: NEO Five-Factor Inventory
timeFrame: Change from Baseline NEO Five-Factor Inventory at 6 months.
measure: Toronto Alexithymia Scale (TAS)
timeFrame: Change from Baseline Toronto Alexithymia Scale at 6 months.
measure: Global Assessment Functioning (GAF)
timeFrame: Change from Baseline Global Assessment Functioning at 6 months.
measure: Personal and Social Performance scale (PSP)
timeFrame: Change from Baseline Personal and Social Performance scale at 6 months.
measure: EuroQuol-VAS (EQ-VAS)
timeFrame: Change from Baseline EQ-VAS at 6 months.
measure: Boston University Empowerment Scale (BUES)
timeFrame: Change from Baseline Boston University Empowerment Scale at 6 months.
measure: Questionnaire about the Process of Recovery
timeFrame: Change from Baseline Questionnaire about the Process of Recovery at 6 months.
measure: Visual numerical scale of recovery
timeFrame: Change from Baseline Visual numerical scale of recovery at 6 months.
measure: Psychotic Symptom Rating Scales-hallucinations (PSYRATS-H)
timeFrame: Change from Baseline Psychotic Symptom Rating Scales at 6 months.
measure: Peters Delusions Inventory (PDI)
timeFrame: Change from Baseline Peters Delusions Inventory at 6 months.
measure: Scale Unawareness of Mental Disorders (SUMD)
timeFrame: Change from Baseline Scale Unawareness of Mental Disorders at 6 months.
measure: Beck Cognitive Insight Scale
timeFrame: Change from Baseline Beck Cognitive Insight Scale at 6 months.
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.
measure: Baron Cohen's Face Test
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Involuntary Autobiographical Memory Inventory (IAMI)
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Voluntary Control Questions (VCQ)
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Cognitive Biases Questionnaire for Psychosis (CBQp)
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Brief Core Schema Scales
timeFrame: Data will be collected at the baseline and immediately after the intervention.
measure: Brief Experiential Avoidance Questionnaire Questionnaire
timeFrame: Data will be collected at the baseline and immediately after the intervention.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Hospital de Sant Pau
name: Iluminada Corripio, PhD
role: PRINCIPAL_INVESTIGATOR
References: