eMotiph: E-mental Health Solution for Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345977
• Other study ID #: 12470-2
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2024
• Source: Grupo Pulso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• eMotiph
Mobile application for patients with schizophrenia.

Locations

Country	Name	City	State
Spain	Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Grupo Pulso	Fundació Tic Salut i Social, Hospital de Sant Pau, Nurogames GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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.
Secondary	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.
Secondary	Beck Anxiety Inventory (BAI)	The level of anxiety will be assessed. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.	Change from Baseline Beck Anxiety Inventory at 6 months.
Secondary	Clinical Global Impression (CGI)	The severity of positive, negative, depressive and cognitive symptoms and the overall severity of the disorder will be evaluated. The scale is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A higher score indicates a higher severity level.	Change from Baseline Clinical Global Impression at 6 months.
Secondary	NEO Five-Factor Inventory	Measurement of five personality traits: five factors are named Neuroticism (N), Extraversion (E), Openness. Higher scores indicates higher presence of the trait.; (O), Agreeableness (A), and Conscientiousness (C).	Change from Baseline NEO Five-Factor Inventory at 6 months.
Secondary	Toronto Alexithymia Scale (TAS)	Measurement of alexithymia personality trait. Scoring range: 20-100 (higher scores indicate greater impairment).	Change from Baseline Toronto Alexithymia Scale at 6 months.
Secondary	Global Assessment Functioning (GAF)	The overall functioning of the patient will be evaluated. The score is between 0-100, where lower scores indicate psychosocial problems that make life difficult for the person under evaluation.	Change from Baseline Global Assessment Functioning at 6 months.
Secondary	Personal and Social Performance scale (PSP)	The specific functioning in 4 main areas will be evaluated. The final score ranges from 100 to 0, where from 100 to 70 points, the ratings refer only to mild difficulties, from 70 to 31 to manifest disabilities of various degrees, and under 30 points, the person's functioning is so poor that intensive support or supervision is needed	Change from Baseline Personal and Social Performance scale at 6 months.
Secondary	EuroQuol-VAS (EQ-VAS)	Measurement of quality of life according to the patient's perception. It is a 0-100 scale where respondents indicate their overall health status. A higher score indicates higher perceived health.	Change from Baseline EQ-VAS at 6 months.
Secondary	Boston University Empowerment Scale (BUES)	Measurement of the personal construct of empowerment. The BUES is a 28-item self-report questionnaire which consists of five factors: self-efficacy and self-esteem, power and powerlessness, community activism, righteous anger, and optimism toward and control over the future. Possible scores range from 1 to 4, with higher scores indicating more empowerment.	Change from Baseline Boston University Empowerment Scale at 6 months.
Secondary	Questionnaire about the Process of Recovery	Measurement of patient's viewpoint about recovery from psychosis. The QPR is a 15-item self-report questionnaire scored on a 4-point scale (0= disagree strongly, 4=agree strongly). Higher scores are indicative of recovery.	Change from Baseline Questionnaire about the Process of Recovery at 6 months.
Secondary	Visual numerical scale of recovery	Subjective measurement of recovery. This scale ranges from 0 to 10, and higher scores are indicative of recovery.	Change from Baseline Visual numerical scale of recovery at 6 months.
Secondary	Psychotic Symptom Rating Scales-hallucinations (PSYRATS-H)	Measurement of severity of each hallucination's dimensions. PSYRATS-H is comprised of 11 items on specific dimensions of hallucinations, with each item being rated from 0 (absent) to 4 (severe). The total score ranges from 2 to 44, with higher scores indicating more severe symptoms.	Change from Baseline Psychotic Symptom Rating Scales at 6 months.
Secondary	Peters Delusions Inventory (PDI)	Assessment of delusional symptoms. The PDI is a 21-item questionnaire. Total score is the sum of positive responses on each item, giving a maximum score of 21 points. Likewise, for each one of the items, there are three subscales that measure degree of conviction, preoccupa- tion, and distress The higher the score, the greater the delusional symptoms is.	Change from Baseline Peters Delusions Inventory at 6 months.
Secondary	Scale Unawareness of Mental Disorders (SUMD)	Assessment of insight into illness. The scale consists of 3 general items: awareness of mental disorder, awareness of the effects of medication and awareness of the social consequences of the disorder; and of 17 items related to specific symptoms, which make up two subscales: awareness and attribution. Higher scores indicate a lower level of disorder awareness or more incorrect attribution (worse awareness).	Change from Baseline Scale Unawareness of Mental Disorders at 6 months.
Secondary	Beck Cognitive Insight Scale	Assessment of insight into cognitive processes involved in anomalous experiences and misinterpretations. The BCIS is a 15-item self-report questionnaire scored on a 4-point scale (0= do not agree at all, 3= agree completely). It is comprised of two subscales, self-reflectiveness and self-certainty, and a composite Reflectiveness-Certainty Index score. The higher this index score, the greater the cognitive insight is.	Change from Baseline Beck Cognitive Insight Scale at 6 months.
Secondary	Overall Depression Severity and Impairment Scale (ODSIS)	The level of depression severity will be assessed. ODSIS is a 5-item self-report questionnaire and is scored on a Likert-type scale ranging from 0 to 4. Higher scores indicate greater severity and functional interference associated with depression.	Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.
Secondary	Overall Anxiety Severity and Impairment Scale (OASIS)	The level of anxiety severity will be assessed. OASIS is a 5-item self-report questionnaire and is scored on a Likert-type scale ranging from 0 to 4. Higher scores indicate greater anxiety-related severity and impairment.	Data will be collected at baseline, throughout the Unified Protocol sessions and immediately after the intervention.
Secondary	Baron Cohen's Face Test	Measurement of capacity to recognise basic and complex emotions in faces. consists of 20-items showing pictures of an actress displaying an emotion. Higher scores indicate a greater capacity for recognizing emotions.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Emotion Regulation Questionnaire (ERQ)	Measurement of the tendency to regulate emotions. The ERQ is a self-report questionnaire and is scored on a Likert-type scale, ranging from 1 (strongly disagree) to 7 (strongly agree). It is comprised of two subscales, cognitive reappraisal and expressive suppression. Higher scores indicate higher usage of the strategies.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Difficulties in Emotion Regulation Scale (DERS)	Measurement of emotional regulation's dimensions. The DERS is a 28-item self-report questionnaire and is scored on a Likert-type scale, ranging from 1 (almost never) to 5 (almost always). It is comprised of five subscales (inattention, confusion, rejection, interference, lack of control) and a total score. Higher scores indicate higher difficulties in emotion regulation.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Five Facet Mindfulness Questionnaire (FFMQ)	Assessment of mindfulness' facets. The FFMQ is a 39-item self-report measure and is scored on a Likert-type scale, ranging from 1 (never) to 5 (very often). It is comprised of five subscales: Observing, Describing, Acting with Awareness, Nonjudging of Inner Experience, and Nonreactivity to Inner Experience. Higher scores represent higher subscale levels of mindfulness.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Involuntary Autobiographical Memory Inventory (IAMI)	Measurement of the frequency of involuntary autobiographical memories and involuntary future thoughts. The IAMI is a 20-item self-report measure and is scored on a Likert-type scale, ranging from 0 (never) to 4 (once every hour or more). It is comprised of two subscales: frequency of future involuntary events and frequency of past involuntary events. Higher scores represent higher subscale levels of involuntary memory and thoughts.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Voluntary Control Questions (VCQ)	Measurement of the frequency of voluntary autobiographical memories and future thoughts. The VCQ is a 10-item self-report measure and is scored on a Likert-type scale, ranging from 0 (never) to 4 (once every hour or more). It is comprised of two subscales: frequency of future voluntary events and frequency of past voluntary events. Higher scores represent higher subscale levels of voluntary memory and thoughts.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Cognitive Biases Questionnaire for Psychosis (CBQp)	Assessment of bias related to psychosis. The CBQp consist of 30 descriptions of everyday situations related to anomalous perceptions or threatening events. Each group of statements covers five cognitive biases: intentionalising, catastrophising, dichotomous thinking, jumping to conclusions and emotional reasoning. Higher scores represent higher level of cognitive biases.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Brief Core Schema Scales	Measurement of schemas. The BCSS have 24 items concerning beliefs about the self and others that are assessed on a five-point rating scale (0-4). Four scores are obtained: negative-self, positive- self, negative-others and positive-others. Higher scores indicate a greater endorsement of a schema.	Data will be collected at the baseline and immediately after the intervention.
Secondary	Brief Experiential Avoidance Questionnaire Questionnaire	Measurement of the functional process to connect with emotions. The BEAQ is comprised of 15 items, with each item being rated from 1 (Strongly disagree) to 6 (Strongly agree). The total score ranges from 15 to 90, with higher scores indicating more experiential avoidance.	Data will be collected at the baseline and immediately after the intervention.