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21 March 2013
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| [ Print-friendly version ] |
| Emotion recognition training and brain responses |
| ISRCTN | ISRCTN50125738 |
| DOI | 10.1186/ISRCTN50125738 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Emotion recognition training and brain responses |
| Scientific title | Identifying the neural substrates of emotion recognition and mood processing targets in an emotion recognition training procedure |
| Acronym | N/A |
| Serial number at source | UOB1700 |
| Study hypothesis | We hypothesise that emotional recognition training will reduce amygdala responses to negative facial expressions. We also hypothesise that training will alter activity in the occipital cortex because it is highly connected to the amygdala and is sensitive to attentional change in response to emotional stimuli and the prefrontal cortex which exerts effects on circuitry implicated in pharmacological and psychological treatment for depression. |
| Lay summary |
Background and study aims
Faces play a key role in everyday life, and the accurate recognition of emotional content in faces is critical to social functioning. This is disrupted in a range of psychiatric disorders – for example, people with depression show a negative bias whereby they fail to identify happiness in faces. We have developed a new concept which targets the recognition of facial expression of emotions by initially assessing the threshold for detecting one emotion over another in an ambiguous (unclear) 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). Preliminary results from adults recruited from the general population on the basis of high levels of depressive symptoms show that this manipulation of the perception of emotion in ambiguous facial expressions, designed to promote the perception of positive emotion over negative emotion, may have therapeutic (remedial) benefit which persists for at least two weeks. The present project aims to investigate brain responses during the emotion recognition training procedure in individuals with low mood. Who can participate? The study will recruit adults aged 18 and 40 years, either sex, from the general population who report high levels of depressive symptoms (defined as a score of 14 or more on the Beck Depression Inventory; BDI-ii). What does the study involve? The study will evaluate a computer-based training programme that is designed to modify recognition of ambiguous facial expressions, from seeing them as expressing sadness to seeing them as expressing happiness. This training is designed to promote the perception of positive emotion over negative emotion. The participants will be randomly allocated to either a treatment group, which will receive feedback designed to shift their recognition of ambiguous faces as displaying happiness rather than sadness, or a control group which will receive feedback not designed to shift their recognition. What are the potential benefits and risks of participating? Participants would not directly benefit from taking part in this research study. However, the information we get from this study may help us to understand the influence of emotion perception on low mood. There are no expected risks of taking part in this study. Where is the study run from? The study will be run in the School of Experimental Psychology, 12a Priory Road, University of Bristol and CRIC Bristol, University of Bristol. When is the study starting and how long will it be expected to run for? The study is expected to run from November 2012 to May 2013 Who is funding the study? The study is being organised by the University of Bristol, and is funded by a Medical Research Council (MRC) grant MR/J011819/1. Who is the main contact? Dr Sally Adams sally.adams@bristol.ac.uk |
| Ethics approval | Faculty of Science Human Research Ethics Committee, 13th September 2012, Reference: 130912583 |
| Study design | Double-blind placebo controlled study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Low mood / depression |
| Participants - 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. Right-handed (as assessed by Edinburgh Handedness Inventory) 5. Able to give informed consent as judged by lead researcher |
| Participants - 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, cognitive behavioural therapy or other psychotherapies). We will allow intermittent use of medication, judged by the principal investigator. 7. Participants who have contra-indication for magnetic resonance imaging (MRI) imaging 8. Participants unable to tolerate the scanner environment |
| Anticipated start date | 01/11/2012 |
| Anticipated end date | 30/05/2013 |
| Status of trial | Ongoing |
| Patient information material | Patient information material can be found at http://www.bristol.ac.uk/expsych/research/brain/targ/participants/emotionbrain.html |
| Target number of participants | 36 |
| Interventions |
Emotion Recognition Training (ERT) vs. Control
Session 1: The first session will involve a screening assessment to ensure that participants fit the requirements of the study and are in general good physical and psychological health. During this session participants will also complete questionnaire measures and will be required a computer-based emotion perception task. Participants will be randomised to one of 2 groups: treatment or control. This session would last approximately 60 minutes. Sessions 2-5: We will ask participants to attend four sessions on consecutive days (or as close as possible) to complete the computer-based emotion perception task and a series of questionnaires rating mood. These sessions should last approximately 25 minutes. Session 5: We will ask participants to undergo a MRI scan consisting of two parts. Participants will first undergo an anatomical MRI scan; this will last approximately 5 minutes and participants will just lie still. In the second part of the MRI scan participants will view images projected on a screen above their head. This session would last approximately 60 minutes. |
| Primary outcome measure(s) | Neural response to emotional cues: Blood oxygen level dependent (BOLD) responses to emotional facial expression |
| Secondary outcome measure(s) |
1. Depressive symptoms: Hamilton Rating Scale for Depression (HAM-D)
2. Anxiety symptoms: Beck Anxiety Inventory (BAI) (rated over the past week) 3. Positive affect: Positive and Negative Affect Schedule (PANAS) (rated over the past day) 4. Negative affect: Positive and Negative Affect Schedule (PANAS) (rated over the past day) |
| Sources of funding | Medical Research Council (MRC) (UK) grant ref: MR/J011819/1 |
| Trial website | http://www.bristol.ac.uk/expsych/research/brain/targ/participants/emotionbrain.html |
| Publications | |
| Contact name | Prof Marcus Munafo |
| Address |
Office 5D5
University of Bristol Experimental Psychology 12a Priory Road Clifton |
| City/town | Bristol |
| Zip/Postcode | BS8 1TU |
| Country | United Kingdom |
| Sponsor | University of Bristol (UK) |
| Address |
Research and Enterprise Development
3rd Floor, Senate House Tyndall Avenue |
| City/town | Bristol |
| Zip/Postcode | BS8 1TH |
| Country | United Kingdom |
| Sponsor website: | http://www.bris.ac.uk/red/ |
| Date applied | 19/10/2012 |
| Last edited | 21/01/2013 |
| Date ISRCTN assigned | 21/01/2013 |
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