Condition category
Mental and Behavioural Disorders
Date applied
02/07/2015
Date assigned
24/07/2015
Last edited
24/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background study and aims
Social cognition (SC) refers to the ability to understand what the others are thinking or feeling. SC includes perception of emotions in faces, voices and body language and interpretation of the intentions and behaviors of others in social situations. In recent years, disorders in SC have been described in patients with schizophrenia and other mental disorders. The study of these deficits is important because SC appears to have greater impact on social function than other factors. Moreover, rehabilitation of SC deficits is possible using different therapeutic models; unfortunately all systems available require a significant number of rehabilitation sessions (between 12 and 45), typically applied in a group setting and requiring specific training by the therapists, a factor that can hinder their application in clinical settings. With this aim our research group designed a SC rehabilitation online program called e-Motional Training®. Our main objective is to assess the effectiveness of e-Motional Training® in patients with schizophrenia.

Who can participate?
Patients aged 18-50 with schizophrenia.

What does the study involve?
Participants will be randomly allocated into two groups. In the intervention group patients will attend 12 weekly sessions of 1 - 1.5 hours duration where they are going to play different tutorials and computer games designed by our team. The first four sessions will involve improving recognition of emotions and the next eight sessions will involve watching a cartoon depicting different communication woes that the patient has to explain. The control group will receive treatment as usual: occupational therapy and leisure activities. All participants will be evaluated before the intervention and 1 month after completing it using psychological tests that take around two hours with a brief rest.

What are the possible benefits and risks of participating?
The possible benefit is an improved ability to understand other people’s facial expressions and intentions, and no side effects are expected.

Where is the study run from?
Complexo Hospitalario Universitario de Ourense (Spain).

When is the study starting and how long is it expected to run for?
From January 2015 to December 2015.

Who is funding the study?
Servizo Galego de Saúde (Galician Health Authority) (Spain).

Who is the main contact?
Dr Alejandro Garcia-Caballero
alejandro.garcia.caballero@sergas.es

Trial website

Contact information

Type

Public

Primary contact

Dr Alejandro Garcia-Caballero

ORCID ID

Contact details

Servicio de Psiquiatría
Complexo Hospitalario Universitario de Ourense (CHUO)
Hospital Santa Maria Nai
Rúa Ramón Puga 52-55
Ourense
32005
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AAGC-EMOESQ-2014

Study information

Scientific title

"e-Motional Training": randomized controlled trial of a novel social cognition online program for patients with schizophrenia

Acronym

E-MOSCH

Study hypothesis

E-Motional Training online program improves social cognition (emotion recognition and theory of mind) in comparison with treatment as usual.

Ethics approval

Clinical Research Ethics Committee of Galicia (Comité Autonómico de Ética da Investigación de Galicia), EC registry code: 2014/459

Study design

Interventional randomised multicenter single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia

Intervention

1. Intervention group attends 12 weekly sessions of 1 - 1.5 hours duration. The first 4 meetings (1 h each session) are dedicated to recognizing facial emotions. This includes a pretest and posttest, a number of tutorials, facial minigames that include isolated parts of the face (eyes and mouth), as well as training in recognizing microexpressions (<250 ms) and morphing (faces change from a neutral expression to a specific emotion; the user must determine as quickly as possible what emotion the face will change to).
The next 8 sessions (1 h each) include watching a short interactive animated cartoon in which a couple invites their friends to their home for a party. Over the course of the story, various communication woes occur between the actors, which cause emotions and various mental conditions such as anger, affection, appreciation, jealousy, etc. After each scene, the user is presented several questions on what happened, including questions about ToM (interpreting irony, insinuations, faux pas, 2nd-order false beliefs, etc.), social perception, attributive style and control questions. The game provides user feedback and, in the event of error, can display a hyperlink with information, whose objective is to help understand the scene the user just watched.
The e-Motional Training® has a software platform that stores the results of each session individually, storing the results in a database with access restricted to the practitioner.

2. Treatment as usual: occupational therapy and leisure activities

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Patients are going to be studied with the following battery prior to randomisation and 1 month after the intervention.
1. Ekman 60 Faces Test (Ekman, 1976): A computer test based on the facial recognition of emotional expressions. The test contains 60 photographs of faces with expressions of the 6 basic emotions: anger, disgust, sadness, fear, surprise and happiness.
2. Hinting Task (Corcoran, Mercer, & Frith, 1995) (Spanish version of Gil, 2012): The individual must identify what the story’s character really meant to say.
3. Recognition of Faux Pas (Baron-Cohen, 1997): The participant must identify the embarrassing situations or gaffes.
4. Strange Stories of F. Happé (Spanish Version of Pousa, 1999): The participant must understand the emotions, intentions and thoughts of the characters in the various stories.
5. Positive and Negative Symptom Scale (PANSS) (Kay, Fiszbein and Opler, 1987): Assesses positive and negative symptom severity.
6. Lahera G, Boada L, Pousa E, Mirapeix I, Morón-Nozaleda G, Marinas L, Gisbert L, Pamiàs M, Parellada M. Movie for the Assessment of Social Cognition (MASC): Spanish Validation. Journal of Autism and Developmental Disorders (2014).

Secondary outcome measures

Prior to randomisation and 1 month after intervention, both groups (e-Motional Training & TAU) will be studied with:
1. Ambiguous Intentions Hostility Questionnaire (AIHQ) (Combs, Penn, Wicher and Waldheter, 2007): Assesses attributional biases in 3 types of situations (ambiguous, intentional and accidental).
2. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. Br J Psychiatry. 1990 Dec;157:853-9. Spanish version: Torres A, Olivares JM. Validation of the Spanish version of the Social Functioning Scale. Actas Esp Psiquiatr. 2005 Jul-Aug;33(4):216-20.

Overall trial start date

01/01/2015

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who voluntarily agree to participate in the study
2. Aged 18-50 years
3. Diagnosis of schizophrenia (DSM-5)
4. Clinically stable
5. No comorbidity with other psychiatric or neurological diseases (International Neuropsychiatric Interview-MINI) or current substance abuse
6. Score at F. Happé´s Strange Stories test lower than 14

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

N=60, 30 patients in the intervention group and 30 in the control group

Participant exclusion criteria

1. Psychiatric, neurological comorbidity, or active substance disorder
2. Acute schizophrenic symptomatology
3. Suicidal ideation
4. ToM score in F. Happé´s Strange Stories >14

Recruitment start date

01/01/2015

Recruitment end date

30/11/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Complexo Hospitalario Universitario de Ourense
Rúa Ramón Puga 54
Ourense
32005
Spain

Trial participating centre

Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela
-
Spain

Trial participating centre

Complexo Hospitalario Universitario de A Coruña
A Coruña
-
Spain

Trial participating centre

Complexo Hospitalario Universitario de Vigo
Vigo
-
Spain

Trial participating centre

Asociación Doa
Vigo
-
Spain

Trial participating centre

Asociación APEM
A Coruña
-
Spain

Trial participating centre

Asociación Morea
Ourense
-
Spain

Trial participating centre

Asociación Virxe da Cerca
Santiago de Compostela
-
Spain

Sponsor information

Organisation

Servizo Galego de Saúde (Galician Health Authority)

Sponsor details

Edificio Administrativo San Lázaro
Santiago de Compostela
15703
Spain

Sponsor type

Government

Website

http://www.sergas.es/

Funders

Funder type

Hospital/treatment centre

Funder name

Servizo Galego de Saúde (Galician Health Authority)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Communication of preliminary results in National (Spanish) psychiatric and psychological conferences.
Communication of final results at European Congress of Psychiatry or World Congress of Psychiatry
Publication in Schizophrenia Research or Sch Res Cognition

Intention to publish date

31/05/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes