Condition category
Mental and Behavioural Disorders
Date applied
24/03/2017
Date assigned
26/04/2017
Last edited
26/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.e-motionaltraining.com/

Contact information

Type

Scientific

Primary contact

Mrs Carmen Armas Barbazán

ORCID ID

Contact details

Hospital Comarcal de Monforte
Corredoira s/n
Monforte de Lemos
27400
Spain

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 measures

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

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

http://www.sergas.es/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes