Condition category
Mental and Behavioural Disorders
Date applied
06/07/2012
Date assigned
12/09/2012
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Faces play a key role in everyday life; recognising emotions on faces is important to social functioning. This is difficult in some psychiatric disorders – for example, people with depression are unable to identify happiness in faces. We have developed a new computer-based training programme which targets the recognition of facial expression of emotions by initially assessing the threshold for detecting one emotion over another in an ambiguous expression (e.g., a blend of happiness and sadness), and then providing feedback to shift this threshold (e.g., to favour identification of happiness over sadness), promoting the perception of positive emotion over negative emotion. This study aims to establish the effects of emotion recognition training on mood in people with high levels of depressive symptoms over a 6-week follow-up period.

Who can participate?
Adults aged between 18 and 40 with high levels of depressive symptoms.

What does the study involve?
The participants will be randomly allocated to either a treatment group, who will receive feedback designed to shift their recognition of ambiguous faces as displaying happiness rather than sadness, or to a control group, who will receive feedback not designed to shift their recognition. Depressive symptoms will be measured at the end of treatment and 2 and 6 weeks after training.

What are the potential benefits and risks of participation?
Participants would not directly benefit from taking part in this study. However, the information we get from this study may help us to understand the influence of emotion perception on low mood.

Where will the study be run from?
School of Experimental Psychology, University of Bristol (UK).

When is the study starting and how long will it be expected to run for?
The study is expected to run from August 2012 to December 2013.

Who is funding the study?
Medical Research Council (UK).

Who is the main contact?
Dr Sally Adams
sally.adams@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marcus Munafò

ORCID ID

Contact details

University of Bristol
School of Experimental Psychology
12A Priory Road
Bristol
BS8 1TU
United Kingdom
+44 (0)117 954 6841
marcus.munafo@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UoB: 1701

Study information

Scientific title

Effects of Emotion Recognition Training on mood among individuals with high levels of depressive symptoms

Acronym

ERT

Study hypothesis

We hypothesise that individuals randomised to receive an intervention designed to modify emotion perception designed to increase the perception of happiness over sadness in ambiguous expressions will show reduced depressive symptoms, reduced negative affect and increased positive effect, compared with individuals randomised to receive a placebo intervention.

Ethics approval

Faculty of Science Human Ethics Research Committee, University of Bristol, 02/05/2012, ref: 211010468

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mood disorders

Intervention

We have developed a new paradigm which targets the recognition of facial expression of emotions by initially assessing the threshold for detecting one emotion over another in an ambiguous expression (e.g., a blend of happiness and sadness), and then providing feedback to shift this threshold (e.g., to favour identification of happiness over sadness). Training consists of feedback to shift the participant's balance point, estimated by presenting exemplar faces from a 15-frame morphed face image continuum using a two-alternative forced choice procedure. In the training condition, the 'correct' classification shifted two morph steps towards 'happy'; the two images nearest the balance point that the participant would have previously classified as 'angry' at baseline were considered 'happy' in terms of providing feedback.

Feedback in the control condition was based directly on baseline performance.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 17/05/2013:
Depressive symptoms: Beck Depression Inventory-ii; BDI-ii (rated over the past two weeks)

Previous primary outcome measures until 17/05/2013:
Depressive symptoms: BDI-II (Mood rated over the past week)

Secondary outcome measures

Current secondary outcome measures as of 17/05/2013:
1. Depressive symptoms: Hamilton Rating Scale for Depression; HAM-D
2. Anxiety symptoms: Beck Anxiety Inventory; BAI (rated over the past month)
3. Positive affect: Positive and Negative Affect Schedule; PANAS (rated as 'how you feel right now')
4. Negative affect: Positive and Negative Affect Schedule; PANAS (rated as 'how you feel right now')
5. Emotion sensitivity: Emotion Recognition Task (test phase); ERT
6. Approach motivation and persistence: The Fishing Game
7. Depressive interpretation bias: The Scrambled Sentences Test; SST

Previous secondary outcome measures until 17/05/2013:
1. Depressive symptoms: Hamilton Rating Scale for Depression (HAM-D)
2. Anxiety symptoms: Beck Anxiety Inventory (BAI) (mood rated over the past week)
3. Positive affect: Positive and Negative Affect Schedule (PANAS) (mood rated over the past day)
4. Negative affect: Positive and Negative Affect Schedule (PANAS) (mood rated over the past day)
5. Emotion sensitivity: Emotion Recognition Task (ERT) (test phase)
6. Approach motivation and persistence: The Fishing Game
7. Depressive interpretation bias: The Scrambled Sentences Test (SST)

Overall trial start date

25/07/2012

Overall trial end date

01/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 40 years
2. Participants who score 14 or higher on the Beck Depression Inventory (BDI)-II
3. English as first language or equivalent level of fluency
4. Able to give informed consent as judged by lead researcher

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

1. Primary anxiety disorder, psychosis, bipolar disorder or substance dependence [other than nicotine and caffeine] as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
2. Current use of illicit drug (except cannabis)
3. Being at clinically significant risk for suicidal behaviour
4. Use of psychotropic medication in last 5 weeks prior to study
5. Major somatic or neurological disorders and concurrent medication which could alter emotional processing (including active treatment with counselling, psychotherapy and cognitive behavioural therapy). We will allow intermittent use of medication, judged by the principal investigator.
6. Participants who in opinion of the lead researcher are not appropriate to participate

Recruitment start date

25/07/2012

Recruitment end date

01/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TU
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 8676
Red-Office@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bris.ac.uk/red/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) ref: MR/J011819/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23725208

Publication citations

  1. Protocol

    Adams S, Penton-Voak IS, Harmer CJ, Holmes EA, Munafò MR, Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial., Trials, 2013, 14, 161, doi: 10.1186/1745-6215-14-161.

Additional files

Editorial Notes