eMotiph: E-mental Health Solution for Patients With Schizophrenia

Study Overview
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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.

Official Title
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eMotiph: Smart and Innovative E-mental Health Solution to Manage Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: eMotiph


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective non-randomised feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol<br>The psychotherapy Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. | Device: eMotiph<br>* Mobile application for patients with schizophrenia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) | 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. | Change from Baseline Positive and Negative Syndrome Scale at 6 months. | 
| Calgary Depresion Scale for Schizophrenia (CDS) | The level of depression severity in schizophrenia will be assessed. Cut off points: 0-5, no depression; 6-27, depression. | Change from Baseline Calgary Depresion Scale for Schizophrenia at 6 months. | 
| Beck Anxiety Inventory | The level of anxiety will be assessed. | Change from Baseline Beck Anxiety Inventory at 6 months. | 
| Clinical Global Impression | The severity of positive, negative, depressive and cognitive symptoms and the overall severity of the disorder will be evaluated. | Change from Baseline Clinical Global Impression at 6 months. | 
| NEO Five-Factor Inventory | Measurement of personality traits. | Change from Baseline NEO Five-Factor Inventory at 6 months. | 
| Toronto Alexithymia Scale | Measurement of alexithymia personality trait. | Change from Baseline Toronto Alexithymia Scale at 6 months. | 
| Global Assessment Functioning | The overall functioning of the patient will be evaluated. | Change from Baseline Global Assessment Functioning at 6 months. | 
| Personal and Social Performance scale | The specific functioning in 4 main areas will be evaluated. | Change from Baseline Personal and Social Performance scale at 6 months. | 
| EuroQol-5 Dimensions-5 Levels | Measurement of quality of life according to the patient's perception. | Change from Baseline EuroQol-5 Dimensions-5 Levels at 6 months. | 
| Adherence to Refills and Medications Scale | Measurement of adherence to pharmacological treatment in multiple pathological patients. | Change from Baseline Adherence to Refills and Medications Scale at 6 months. | 
| Boston University Empowerment Scale | Measurement of the personal construct of empowerment. | Change from Baseline Boston University Empowerment Scale at 6 months. | 
| Questionnaire about the Process of Recovery | Measurement of patient's viewpoint about recovery from psychosis. | Change from Baseline Questionnaire about the Process of Recovery at 6 months. | 
| Clinical Outcomes in Routine Evaluation-Outcome Measure | Measurement of the patient's condition based on the dimensions: Subjective well-being, Problems / Symptoms, General functioning, Risk | Change from Baseline Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months. | 
| Functional social support questionnaire (The Duke- UNC-11) | Measurement of perceived functional social support. | Change from Baseline Functional social support questionnaire at 6 months. | 
| Personal Resilience | Measurement of personal resilience. | Change from Baseline Personal Resilience at 6 months. | 
| Visual numerical scale of recovery | Subjective measurement of recovery. | Change from Baseline Visual numerical scale of recovery at 6 months. | 
| Psychotic Symptom Rating Scales | Measurement of severity of each hallucination's dimensions. | Change from Baseline Psychotic Symptom Rating Scales at 6 months. | 
| Peterson Delusions Inventory | Assessment of delusional symptoms | Change from Baseline Peterson Delusions Inventory at 6 months. | 
| Scale Unawareness of Mental Disorders | Assessment of insight into illness. | Change from Baseline Scale Unawareness of Mental Disorders at 6 months. | 
| Beck Cognitive Insight Scale | Assessment of insight into cognitive processes involved in anomalous experiences and misinterpretations. | Change from Baseline Beck Cognitive Insight Scale at 6 months. | 
| Overall Depression Severity and Impairment Scale | The level of depression severity will be assessed. | Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention. | 
| Overall Anxiety Severity and Impairment Scale | The level of anxiety severity will be assessed. | Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention. | 
| Faces Test | Measurement of capacity to recognise basic and complex emotions in faces. | Data will be collected at the baseline and immediately after the intervention. | 
| Emotion Regulation Questionnaire | Measurement of the tendency to regulate emotions. | Data will be collected at the baseline and immediately after the intervention. | 
| Difficulties in Emotion Regulation Scale | Measurement of emotional regulation's dimensions. | Data will be collected at the baseline and immediately after the intervention. | 
| The Safety Behavior Assessment Form | Assessment of safety behaviour usage. | Data will be collected at the baseline and and immediately after the intervention. | 
| Five Facet Mindfulness Questionnaire | Assessment of mindfulness' facets. | Data will be collected at the baseline and immediately after the intervention. | 
| Involuntary Autobiographical Memory Inventory | Measurement of the frequency of involuntary autobiographical memories and involuntary future thoughts. | Data will be collected at the baseline and immediately after the intervention. | 
| Voluntary Control Questions | Measurement of the frequency of voluntary autobiographical memories and future thoughts. | Data will be collected at the baseline and immediately after the intervention. | 
| Cognitive Biases Questionnaire for Psychosis | Assessment of bias related to psychosis. | Data will be collected at the baseline and immediately after the intervention. | 
| Brief Core Schema Scales | Measurement of schemas. | Data will be collected at the baseline and immediately after the intervention. | 
| Brief Experiential Avoidance Questionnaire Questionnaire | Measurement of the functional process to connect with emotions. | Data will be collected at the baseline and immediately after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Treatment resistent schizophrenia