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
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
Contact information
Scientific
Hospital Comarcal de Monforte
Corredoira s/n
Monforte de Lemos
27400
Spain
Study information
| Study design | Interventional multi-centre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN15190595_PIS_29Mar17_Spanish.doc |
| Scientific title | Facial emotion imitation training in outpatients with schizophrenia: Demonstrating the effectiveness of facial imitation to improve the recognition of facial emotions |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 04/09/2015 |
| Completion date | 01/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Target number of participants: 50 aprroximately |
| Key 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 |
| Key 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) |
| Date of first enrolment | 24/11/2015 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- Spain
Study participating centres
Monforte de Lemos (Lugo)
27400
Spain
Chantada. (Lugo)
27500
Spain
Zaragoza
50007
Spain
Vigo
36211
Spain
Orense
32005
Spain
Sponsor information
Government
Edif. Admtvo. San Lázaro s/n
Santiago de Compostela
15700
Spain
| Website | http://www.sergas.es/ |
|---|---|
"ROR" |
https://ror.org/0591s4t67 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 18/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan | The 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.
