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Trial record 11 of 36 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND positive | ( Map: Spain )

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

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ClinicalTrials.gov Identifier: NCT02847793
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Carmelo Vázquez, Universidad Complutense de Madrid

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.


Condition or disease Intervention/treatment Phase
Cognitive Deficits Depression Alteration of Cognitive Function Behavioral: Gaze training Behavioral: Placebo intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Changes in Selective Attentional Patterns Towards Emotional Stimuli by Using Eye-tracking Techniques: A New Intervention for Depression
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine


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
Behavioral: 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. (A total of 576 trials will be distributed in a 2-day intervention).
Other Name: 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)
Behavioral: Placebo intervention
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Other Outcome Measures:
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Impaired vision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847793


Locations
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Spain
School of Psychology
Madrid, Spain, 28223
Sponsors and Collaborators
Universidad Complutense de Madrid
Ministerio de Economía y Competitividad, Spain
Investigators
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Principal Investigator: Carmelo Vazquez, Ph.D: Universidad Complutense de Madrid

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carmelo Vázquez, Full Professor of Psychopathology, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT02847793     History of Changes
Other Study ID Numbers: PSI2014-61764-EXPLORA
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carmelo Vázquez, Universidad Complutense de Madrid:
Attentional Bias Modification (ABM)
Cognitive Bias Modification (CBM)
Depression
Dysphoria
Gaze patterns
Eye-tracking
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Cognition Disorders
Cognitive Dysfunction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurocognitive Disorders