- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847793
Attentional Bias Modification Through Eye-tracker Methodology (ABMET) (ABMET)
Changes in Selective Attentional Patterns Towards Emotional Stimuli by Using Eye-tracking Techniques: A New Intervention for Depression
Cognitive biases are a hallmark of depression but there is scarce research on whether these biases can be directly modified by using specific cognitive training techniques.
The aim of this study will be targeting and modifying specifically relevant attention biases in participants with subclinical depression using eye-tracking methodologies. This innovative approach has been proposed as a promising future line of intervention in Attention Bias Modification procedures (Koster & Hoorelbeke, 2015).
Recent findings suggest that depression is characterized by a double attentional bias (Duque & Vazquez, 2015), More specifically, depressed individuals have difficulties both to disengage from negative materials (e.g., sad faces) and to engage with positive materials (e.g., happy faces). Thus, training procedures to change attentional biases should target these two separate components.
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of this study will be to apply eye-tracking methods to modify specific components of attentional bias in depression. Eye-tracking technology enables us to train attention by following strict performance and time-based criteria as well as to specify the components of attention (i.e., disengagement from negative information, engagement and maintenance in positive information) to be targeted in the training, critical to providing a theory-driven intervention (Koster, Baert et al., 2010). In the case of depression, there is also some evidence from eye-tracking studies showing that recovery from an induced negative mood is better when individuals spontaneously direct their gaze towards positive stimuli (Sanchez et al., 2014). Thus extant evidence on attentional biases in depression suggest that modification of these biases could be a fruitful way to change participants' mood.
Although initial positive results of ABM led some authors to propose it as an alternative treatment for emotional disorders (Bar-Haim, 2010; MacLeod & Holmes, 2012), some recent meta-analysis (Mogoase et al. 2014; Cristea et al., 2015) have reduced the enthusiasm of those previous claims.Yet, it is likely that modest results of ABM procedures in depression are, in part, based on flawed methodologies. The proposed study aims to rectify several limitations of previous designs while opening a new strategy, based in training ocular movements, to modify attentional patterns. With a series of methodological and conceptual improvements (i.e., trial-by- trial feedback, use of different tasks to measure attentional bias and to do the ABM, use of a yoked-group design to control for the time exposure to the emotional stimuli in the control group, and use of a stress-test to measure transfer of the training to a different task), it is expected that some limitations found in previous studies can be overcome. The general aim of the study will be to train adaptive attentional biases (i.e., training the maintenance of gaze towards positive stimuli). The use of the new ABM in a sample of dysphoric participants will allow us to test if training visual selective attention using eye-tracking methodology could be a promising venue for future ABM procedures more solidly grounded on current theories of depression.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid, Spain, 28223
- School of Psychology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A score of >13 in the Beck Depression Inventory (BDI-II)
Exclusion Criteria:
- Impaired vision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Gaze training
Participants are required to maintain their gaze in a given picture (e.g., a happy face), for a given time (i.e., 750ms vs 1500 ms) to advance to the next trial
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Participants are required to maintain their gaze in a given picture (e.g., a happy face), for a given time (i.e., 750ms vs 1500 ms) to advance to the next trial.
(A total of 576 trials will be distributed in a 2-day intervention).
Other Names:
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Placebo Comparator: Placebo intervention
Using a matching procedure (i.e., yoked control group), participants are required to maintain their gaze in a given picture (e.g., a happy face), for the same average time that their counterparts in the Gaze training group (i.e.
Experimental group)
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Participants are exposed to the same amount of time to the experimental stimuli used in the experimental group but there is no contingency between participants' gaze patterns and the end of each of the 576 trials.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of current mood (PANAS)
Time Frame: Change from Baseline to the end of the 2-day intervention.It will be administered 12 min before the first session of training and then immediately after finishing the 2nd session of training
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A scale measuring current general positive and negative mood
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Change from Baseline to the end of the 2-day intervention.It will be administered 12 min before the first session of training and then immediately after finishing the 2nd session of training
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Assessment of current mood (EVEA)
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 12 min before the first session of training and then immediately after finishing the 2nd session of training.
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A scale measuring current anger, happiness, anxiety and depressed mood
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Change from Baseline to the end of the 2-day intervention. It will be administered 12 min before the first session of training and then immediately after finishing the 2nd session of training.
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Attentional Bias Assessment Task (ABA, Sanchez et al., 2013)
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered immediately before the first session of training and then 5 min after finishing the 2nd session of training
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An eye-tracking task to measure gaze patterns towards emotional faces
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Change from Baseline to the end of the 2-day intervention. It will be administered immediately before the first session of training and then 5 min after finishing the 2nd session of training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Beck Depression Inventory-II
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training
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Symptoms of depression
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training
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Beck Anxiety Inventory
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Symptoms of anxiety
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Ruminative Responses Scale (RRS)
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training
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Ruminative style
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training
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White Bear Suppression Inventory (WBSI)
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Tendency to suppress distressing thoughts and images
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Behavioral Activation System (BAS)- Behavioral Inhibition System (BIS) Scale
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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A single scale measuring attitudes and behaviors related to the Behavioral Activation System and the Behavioral Items related to sensitivity to punishment and rewards
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Pemberton Happiness Index
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Integrative measure of well-being
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Satisfaction with Life Scale (SWLS)
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Life satisfaction
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Life Orientation Test-Revised (LOT-R)
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Dispositional optimism
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Change from Baseline to the end of the 2-day intervention. It will be administered 20 min before the first session of training and then 20 min after finishing the 2nd session of training.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Emotional Threshold Detection Task (ETDT).
Time Frame: Change from Baseline to the end of the 2-day intervention. It will be administered 15 min before the first session of training and then 15 min after finishing the 2nd session of training
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A morphing task to assess changes in participants' participants' thresholds to detect changes in the facial expression of emotions.
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Change from Baseline to the end of the 2-day intervention. It will be administered 15 min before the first session of training and then 15 min after finishing the 2nd session of training
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Anagram Stress Task (AST)
Time Frame: Immediately after the intervention (i.e., after finishing the 2nd session of training). It will be administered 30 min after finishing the 2nd session of training
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Behavioral persistence in trying to solve anagrams with different levels of difficulty
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Immediately after the intervention (i.e., after finishing the 2nd session of training). It will be administered 30 min after finishing the 2nd session of training
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carmelo Vazquez, Ph.D:, Universidad Complutense de Madrid
Publications and helpful links
General Publications
- Emmelkamp PM. Attention bias modification: the Emperor's new suit? BMC Med. 2012 Jun 25;10:63. doi: 10.1186/1741-7015-10-63.
- Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15.
- Cristea IA, Kok RN, Cuijpers P. Efficacy of cognitive bias modification interventions in anxiety and depression: meta-analysis. Br J Psychiatry. 2015 Jan;206(1):7-16. doi: 10.1192/bjp.bp.114.146761.
- Mogoase C, David D, Koster EH. Clinical efficacy of attentional bias modification procedures: an updated meta-analysis. J Clin Psychol. 2014 Dec;70(12):1133-57. doi: 10.1002/jclp.22081. Epub 2014 Mar 20.
- Macleod C, Holmes EA. Cognitive bias modification: an intervention approach worth attending to. Am J Psychiatry. 2012 Feb;169(2):118-20. doi: 10.1176/appi.ajp.2011.11111682. No abstract available.
- Duque A, Vazquez C. Double attention bias for positive and negative emotional faces in clinical depression: evidence from an eye-tracking study. J Behav Ther Exp Psychiatry. 2015 Mar;46:107-14. doi: 10.1016/j.jbtep.2014.09.005. Epub 2014 Sep 22.
- Sanchez A, Vazquez C, Marker C, LeMoult J, Joormann J. Attentional disengagement predicts stress recovery in depression: an eye-tracking study. J Abnorm Psychol. 2013 May;122(2):303-13. doi: 10.1037/a0031529. Epub 2013 Feb 18.
- Vazquez C, Blanco I, Sanchez A, McNally RJ. Attentional bias modification in depression through gaze contingencies and regulatory control using a new eye-tracking intervention paradigm: study protocol for a placebo-controlled trial. BMC Psychiatry. 2016 Dec 8;16(1):439. doi: 10.1186/s12888-016-1150-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSI2014-61764-EXPLORA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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