Attentional Bias Modification Through Eye-tracker Methodology (ABMET) (ABMET)

October 9, 2018 updated by: Carmelo Vázquez, Universidad Complutense de Madrid

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

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

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28223
        • School of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Impaired vision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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:
  • Attentional Bias Modification (ABM)
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
A scale measuring current general positive and negative mood
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
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.
A scale measuring current anger, happiness, anxiety and depressed mood
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.
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
An eye-tracking task to measure gaze patterns towards emotional faces
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Symptoms of depression
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
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.
Symptoms of anxiety
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.
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
Ruminative style
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
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.
Tendency to suppress distressing thoughts and images
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.
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.
A single scale measuring attitudes and behaviors related to the Behavioral Activation System and the Behavioral Items related to sensitivity to punishment and rewards
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.
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.
Integrative measure of well-being
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.
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.
Life satisfaction
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.
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.
Dispositional optimism
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
A morphing task to assess changes in participants' participants' thresholds to detect changes in the facial expression of emotions.
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
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
Behavioral persistence in trying to solve anagrams with different levels of difficulty
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carmelo Vazquez, Ph.D:, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

July 28, 2017

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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