Clinical trial NCT02847793: Attentional Bias Modification Through Eye-tracker Methodology (ABMET)
Official title: Changes in Selective Attentional Patterns Towards Emotional Stimuli by Using Eye-tracking Techniques: A New Intervention for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Deficits
Depression
Alteration of Cognitive Function
Keywords: Attentional Bias Modification (ABM)
Cognitive Bias Modification (CBM)
Depression
Dysphoria
Gaze patterns
Eye-tracking
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2016-07-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* A score of \>13 in the Beck Depression Inventory (BDI-II)

Exclusion Criteria:

* Impaired vision

Primary outcomes:
measure: Assessment of current mood (PANAS)
timeFrame: 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
measure: Assessment of current mood (EVEA)
timeFrame: 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.
measure: Attentional Bias Assessment Task (ABA, Sanchez et al., 2013)
timeFrame: 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
Secondary outcomes:
measure: Beck Depression Inventory-II
timeFrame: 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
measure: Beck Anxiety Inventory
timeFrame: 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.
measure: Ruminative Responses Scale (RRS)
timeFrame: 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
measure: White Bear Suppression Inventory (WBSI)
timeFrame: 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.
measure: Behavioral Activation System (BAS)- Behavioral Inhibition System (BIS) Scale
timeFrame: 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.
measure: Pemberton Happiness Index
timeFrame: 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.
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 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.
measure: Life Orientation Test-Revised (LOT-R)
timeFrame: 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.
Other outcomes:
measure: Emotional Threshold Detection Task (ETDT).
timeFrame: 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
measure: Anagram Stress Task (AST)
timeFrame: 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
Locations:
city: Madrid
country: Spain
facility: School of Psychology
Study officials:
affiliation: Universidad Complutense de Madrid
name: Carmelo Vazquez, Ph.D:
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Emmelkamp PM. Attention bias modification: the Emperor's new suit? BMC Med. 2012 Jun 25;10:63. doi: 10.1186/1741-7015-10-63.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.