Plain English Summary
Background and study aims
Schizophrenia is a serious mental health condition in which thought and emotions are impaired, causing a person to lose touch with reality. The main symptoms include experiencing hallucinations (hearing and/or seeing things that aren’t there) and delusions (holding strong beliefs that aren’t shared by others, such as believing people are trying to harm them). In addition, people with schizophrenia often have difficulties interacting with others, such as being able to effectively recognise different emotions by people's facial expressions (emotional recognition). Some studies have shown that facial imitation can help to improve emotional recognition. The aim of this study is to look at the effectiveness of an online game of imitation of facial emotions in patients with schizophrenia.
Who can participate?
Patients aged between 18 and 55 years old with schizophrenia.
What does the study involve?
Participants are randomly allocated to one of two groups. In the first group, participants do not receive any specific training and continue as normal. In the second group, participants complete training in imitation of facial emotions, using a computerised game program. Training takes place in two 30 minute sessions per week over eight weeks. At the start of the study and after two months, participants complete tasks to assess their facial recognition skills and questionnaires to assess their symptom severity and knowledge.
What are the possible benefits and risks of participating?
Participants may benefit from better being able to recognise emotions from facial expression which could help in their day to day functioning. There are no notable risks involved with participating.
Where is the study run from?
Treatment centers Albores Monforte-Chantada (Spain)
When is the study starting and how long is it expected to run for?
September 2015 to March 2017
Who is funding the study?
Galician Public Health Service (Spain)
Who is the main contact?
Mrs Carmen Armas Barbazán
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2016/189
Study information
Scientific title
Facial emotion imitation training in outpatients with schizophrenia: Demonstrating the effectiveness of facial imitation to improve the recognition of facial emotions
Acronym
Study hypothesis
The aim of this study is to evaluate applicability as well as to obtain preliminary data on the effectiveness of an online game of imitation of facial emotions in people with schizophrenia when it comes to improving facial recognition.
Ethics approval
Clinical Research Ethics Committee of Galicia (Comité Autonómico de Ética da Investigación de Galicia), EC registry code: 2016/189
Study design
Interventional multi-centre single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Schizophrenia
Intervention
Participants are randomised into one of two group using a sequence of random numbers (N / 2) assigning that sequence to the intervention or random control group.
Intervention group: Participants attend two 30-minute sessions per week for eight weeks of imitation simulation of facial emotions, including e-Motional Training®. For training in imitation of facial emotions, facial recognition software by Sightcorp is used, which has been gamified by the research team. The software detects faces and evaluates, in real time, the intensity of each facial expression according to Ekman's six main emotions (happiness, sadness, anger, surprise, fear and disgust) through the use of a webcam. In addition, an audio tag is played automatically. The patient hears the instruction of the type of emotion that occurs while the imitation takes place. E-Motional Training® offers the patient the opportunity to play and provide feedback at the same time. This occurs by assigning values to the accuracy of the imitation (measuring range: 0-10) until the exact imitation is achieved and the errors that appear throughout the session are corrected in such a way that the patient is encouraged to play.
Control group: Participants do not receive any specific training.
Follow up takes place at reference mental health centers and involves an evaluation before and after the intervention in both groups using a set of neuropsychological tests (cited in the next section)
Intervention type
Device
Phase
Drug names
Primary outcome measure
Facial recognition of emotional expressions is measured using the Ekman 60 Faces Test (Ekman 60) and the Penn Emotion Recognition Task (ER-40 test) at baseline and 2 months.
Secondary outcome measures
1. Symptom severity is assessed using the Positive and Negative Syndrome Scale (PANSS) at baseline and 2 months
2. Verbal and non-verbal knowledge are measured using the Intelligence Test (K-BIT) at baseline and 2 months
Overall trial start date
04/09/2015
Overall trial end date
01/11/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Provision of informed consent to participate
2. Aged between 18 and 55 years old
3. Diagnosed with schizophrenia (DSM-5)
4. Clinically stable
5. Users of mental health facilities in the moment of the research
6. Treated with atypical antipsychotics
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target number of participants: 50 aprroximately
Participant exclusion criteria
1. Presence of a comorbid psychiatric or neurological disorder, intellectual disability
2. Abuse of toxic substances in the moment of the research (excluding nicotine)
Recruitment start date
24/11/2015
Recruitment end date
01/02/2017
Locations
Countries of recruitment
Spain
Trial participating centre
Asociación de Apoyo al enfermo mental ALBORES
Ronda de María Emilia Casas Baamonde, 2
Monforte de Lemos (Lugo)
27400
Spain
Trial participating centre
Asociación de Apoyo al enfermo mental ALBORES
Parque Eloísa Ribadulla.
Chantada. (Lugo)
27500
Spain
Trial participating centre
Centro de Día de Salud Mental de Torrero. Fundación Adunare
C/ Biescas, 11
Zaragoza
50007
Spain
Trial participating centre
Hospital de Día (Hospital Nicolás Peña).
Avda. Camelias, 109
Vigo
36211
Spain
Trial participating centre
Hospital de Día (Hospital Santa María Nai)
Rúa Ramón Puga, 54
Orense
32005
Spain
Sponsor information
Organisation
Servicio Gallego de Salud (SERGAS)
Sponsor details
Edif. Admtvo. San Lázaro s/n
Santiago de Compostela
15700
Spain
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Fundación Biomédica Galicia Sur
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN15190595_PIS_29Mar17_Spanish.doc Uploaded 26/04/2017