Training programme in facial emotions imitation among patients with schizophrenia

ISRCTN ISRCTN15190595
DOI https://doi.org/10.1186/ISRCTN15190595
Secondary identifying numbers 2016/189
Submission date
24/03/2017
Registration date
26/04/2017
Last edited
18/12/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Mrs Carmen Armas Barbazán
Scientific

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

Study information

Study designInterventional multi-centre single-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN15190595_PIS_29Mar17_Spanish.doc
Scientific titleFacial emotion imitation training in outpatients with schizophrenia: Demonstrating the effectiveness of facial imitation to improve the recognition of facial emotions
Study objectivesThe 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(s)Clinical Research Ethics Committee of Galicia (Comité Autonómico de Ética da Investigación de Galicia), EC registry code: 2016/189
Health condition(s) or problem(s) studiedSchizophrenia
InterventionParticipants 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureFacial 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 measures1. 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 study start date04/09/2015
Completion date01/11/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsTarget number of participants: 50 aprroximately
Key inclusion criteria1. 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
Key exclusion criteria1. Presence of a comorbid psychiatric or neurological disorder, intellectual disability
2. Abuse of toxic substances in the moment of the research (excluding nicotine)
Date of first enrolment24/11/2015
Date of final enrolment01/02/2017

Locations

Countries of recruitment

  • Spain

Study participating centres

Asociación de Apoyo al enfermo mental ALBORES
Ronda de María Emilia Casas Baamonde, 2
Monforte de Lemos (Lugo)
27400
Spain
Asociación de Apoyo al enfermo mental ALBORES
Parque Eloísa Ribadulla.
Chantada. (Lugo)
27500
Spain
Centro de Día de Salud Mental de Torrero. Fundación Adunare
C/ Biescas, 11
Zaragoza
50007
Spain
Hospital de Día (Hospital Nicolás Peña).
Avda. Camelias, 109
Vigo
36211
Spain
Hospital de Día (Hospital Santa María Nai)
Rúa Ramón Puga, 54
Orense
32005
Spain

Sponsor information

Servicio Gallego de Salud (SERGAS)
Government

Edif. Admtvo. San Lázaro s/n
Santiago de Compostela
15700
Spain

Website http://www.sergas.es/
ROR logo "ROR" https://ror.org/0591s4t67

Funders

Funder type

Research organisation

Fundación Biomédica Galicia Sur

No information available

Results and Publications

Intention to publish date18/01/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high impact peer reviewed journal.
IPD sharing planThe data has been stored in an Excel database guarded by the research team. The data controller is Carmen Armas Barbazán and the rest of the team.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 29/03/2017 26/04/2017 No Yes
Basic results 18/12/2018 18/12/2018 No No

Additional files

ISRCTN15190595_PIS_29Mar17_Spanish.doc
Uploaded 26/04/2017
ISRCTN15190595_BasicResults_18Dec18.pdf
Uploaded 18/12/2018

Editorial Notes

18/12/2018: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2017 to 18/01/2020.
2. IPD sharing statement added.
3. The basic results of this trial have been uploaded as an additional file.