eMotiph: Smart and Innovative E-mental Health Solution to Manage Patients With Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Grupo Pulso
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- User experience questionnaire
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
User experience questionnaire
Time Frame: Data will be collected immediately after the intervention
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.
Technology Acceptance Model Scale (TAM)
Time Frame: Data will be collected immediately after the intervention.
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.
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Data will be collected immediately after the intervention
The opinions and conclusions about the digital solution delivered will be asked. The scale has not cut off points. Higher values mean higher satisfaction.
Secondary Outcomes
- Clinical Global Impression (CGI)(Change from Baseline Clinical Global Impression at 6 months.)
- Toronto Alexithymia Scale (TAS)(Change from Baseline Toronto Alexithymia Scale at 6 months.)
- NEO Five-Factor Inventory(Change from Baseline NEO Five-Factor Inventory at 6 months.)
- Global Assessment Functioning (GAF)(Change from Baseline Global Assessment Functioning at 6 months.)
- Calgary Depresion Scale for Schizophrenia (CDS)(Change from Baseline Calgary Depresion Scale for Schizophrenia at 6 months.)
- Peters Delusions Inventory (PDI)(Change from Baseline Peters Delusions Inventory at 6 months.)
- Overall Anxiety Severity and Impairment Scale (OASIS)(Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.)
- Positive and Negative Syndrome Scale (PANSS)(Change from Baseline Positive and Negative Syndrome Scale at 6 months.)
- Beck Anxiety Inventory (BAI)(Change from Baseline Beck Anxiety Inventory at 6 months.)
- Questionnaire about the Process of Recovery(Change from Baseline Questionnaire about the Process of Recovery at 6 months.)
- Scale Unawareness of Mental Disorders (SUMD)(Change from Baseline Scale Unawareness of Mental Disorders at 6 months.)
- Beck Cognitive Insight Scale(Change from Baseline Beck Cognitive Insight Scale at 6 months.)
- Baron Cohen's Face Test(Data will be collected at the baseline and immediately after the intervention.)
- Visual numerical scale of recovery(Change from Baseline Visual numerical scale of recovery at 6 months.)
- Emotion Regulation Questionnaire (ERQ)(Data will be collected at the baseline and immediately after the intervention.)
- Difficulties in Emotion Regulation Scale (DERS)(Data will be collected at the baseline and immediately after the intervention.)
- Brief Core Schema Scales(Data will be collected at the baseline and immediately after the intervention.)
- Personal and Social Performance scale (PSP)(Change from Baseline Personal and Social Performance scale at 6 months.)
- Five Facet Mindfulness Questionnaire (FFMQ)(Data will be collected at the baseline and immediately after the intervention.)
- Cognitive Biases Questionnaire for Psychosis (CBQp)(Data will be collected at the baseline and immediately after the intervention.)
- EuroQuol-VAS (EQ-VAS)(Change from Baseline EQ-VAS at 6 months.)
- Boston University Empowerment Scale (BUES)(Change from Baseline Boston University Empowerment Scale at 6 months.)
- Psychotic Symptom Rating Scales-hallucinations (PSYRATS-H)(Change from Baseline Psychotic Symptom Rating Scales at 6 months.)
- Overall Depression Severity and Impairment Scale (ODSIS)(Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.)
- Involuntary Autobiographical Memory Inventory (IAMI)(Data will be collected at the baseline and immediately after the intervention.)
- Voluntary Control Questions (VCQ)(Data will be collected at the baseline and immediately after the intervention.)
- Brief Experiential Avoidance Questionnaire Questionnaire(Data will be collected at the baseline and immediately after the intervention.)