ISRCTN ISRCTN17767674
DOI https://doi.org/10.1186/ISRCTN17767674
Secondary identifying numbers UoB: 1701
Submission date
06/07/2012
Registration date
12/09/2012
Last edited
21/02/2020
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
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

Contact information

Prof Marcus Munafò
Scientific

University of Bristol
School of Experimental Psychology
12A Priory Road
Bristol
BS8 1TU
United Kingdom

Phone +44 (0)117 954 6841
Email marcus.munafo@bristol.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects of Emotion Recognition Training on mood among individuals with high levels of depressive symptoms
Study acronymERT
Study objectivesWe 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(s)Faculty of Science Human Ethics Research Committee, University of Bristol, 02/05/2012, ref: 211010468
Health condition(s) or problem(s) studiedMood disorders
InterventionWe 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 typeOther
Primary outcome measureCurrent 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 measuresCurrent 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 study start date25/07/2012
Completion date01/03/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants190
Total final enrolment190
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment25/07/2012
Date of final enrolment01/03/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Bristol
Bristol
BS8 1TU
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

Research and Enterprise Development
3rd Floor, Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom

Phone +44 (0)117 928 8676
Email Red-Office@bristol.ac.uk
Website http://www.bris.ac.uk/red/
ROR logo "ROR" https://ror.org/0524sp257

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) ref: MR/J011819/1
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan2018 preprint in: https://www.biorxiv.org/content/biorxiv/early/2018/11/01/335042.full.pdf
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/06/2013 Yes No
Results article results 17/02/2020 21/01/2019 Yes No
Results article results 17/02/2020 21/02/2020 Yes No

Editorial Notes

21/02/2020: Publication reference and total final enrolment number added.
21/01/2019: Publication reference added
14/11/2018: Preprint reference added.