eMotiph: E-mental Health Solution for Patients With Schizophrenia

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).

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.

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.

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.

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

Positive, negative and general symptoms of schizophrenia will be assessed. There are not cut off points, direct scores are converted to percentiles. Higher values mean higher presence of positive, negative and general symptoms.

The level of depression severity in schizophrenia will be assessed. Cut off points: 0-5, no depression; 6-27, depression.

The severity of positive, negative, depressive and cognitive symptoms and the overall severity of the disorder will be evaluated.

Measurement of the patient's condition based on the dimensions: Subjective well-being, Problems / Symptoms, General functioning, Risk

Assessment of insight into cognitive processes involved in anomalous experiences and misinterpretations.

Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.

Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.

Measurement of the frequency of involuntary autobiographical memories and involuntary future thoughts.

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.