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

Primary Purpose

Cognitive Deficits, Depression, Alteration of Cognitive Function

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gaze training
Placebo intervention
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Deficits focused on measuring Attentional Bias Modification (ABM), Cognitive Bias Modification (CBM), Depression, Dysphoria, Gaze patterns, Eye-tracking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Impaired vision

Sites / Locations

  • School of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gaze training

Placebo intervention

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Assessment of current mood (PANAS)
A scale measuring current general positive and negative mood
Assessment of current mood (EVEA)
A scale measuring current anger, happiness, anxiety and depressed mood
Attentional Bias Assessment Task (ABA, Sanchez et al., 2013)
An eye-tracking task to measure gaze patterns towards emotional faces

Secondary Outcome Measures

Beck Depression Inventory-II
Symptoms of depression
Beck Anxiety Inventory
Symptoms of anxiety
Ruminative Responses Scale (RRS)
Ruminative style
White Bear Suppression Inventory (WBSI)
Tendency to suppress distressing thoughts and images
Behavioral Activation System (BAS)- Behavioral Inhibition System (BIS) Scale
A single scale measuring attitudes and behaviors related to the Behavioral Activation System and the Behavioral Items related to sensitivity to punishment and rewards
Pemberton Happiness Index
Integrative measure of well-being
Satisfaction with Life Scale (SWLS)
Life satisfaction
Life Orientation Test-Revised (LOT-R)
Dispositional optimism

Full Information

First Posted
July 22, 2016
Last Updated
October 9, 2018
Sponsor
Universidad Complutense de Madrid
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT02847793
Brief Title
Attentional Bias Modification Through Eye-tracker Methodology (ABMET)
Acronym
ABMET
Official Title
Changes in Selective Attentional Patterns Towards Emotional Stimuli by Using Eye-tracking Techniques: A New Intervention for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Deficits, Depression, Alteration of Cognitive Function
Keywords
Attentional Bias Modification (ABM), Cognitive Bias Modification (CBM), Depression, Dysphoria, Gaze patterns, Eye-tracking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gaze training
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo intervention
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Gaze training
Other Intervention Name(s)
Attentional Bias Modification (ABM)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Placebo intervention
Intervention Description
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 Measure Information:
Title
Assessment of current mood (PANAS)
Description
A scale measuring current general positive and negative mood
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
Title
Assessment of current mood (EVEA)
Description
A scale measuring current anger, happiness, anxiety and depressed mood
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.
Title
Attentional Bias Assessment Task (ABA, Sanchez et al., 2013)
Description
An eye-tracking task to measure gaze patterns towards emotional faces
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
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II
Description
Symptoms of depression
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
Title
Beck Anxiety Inventory
Description
Symptoms of anxiety
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.
Title
Ruminative Responses Scale (RRS)
Description
Ruminative style
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
Title
White Bear Suppression Inventory (WBSI)
Description
Tendency to suppress distressing thoughts and images
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.
Title
Behavioral Activation System (BAS)- Behavioral Inhibition System (BIS) Scale
Description
A single scale measuring attitudes and behaviors related to the Behavioral Activation System and the Behavioral Items related to sensitivity to punishment and rewards
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.
Title
Pemberton Happiness Index
Description
Integrative measure of well-being
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.
Title
Satisfaction with Life Scale (SWLS)
Description
Life satisfaction
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.
Title
Life Orientation Test-Revised (LOT-R)
Description
Dispositional optimism
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.
Other Pre-specified Outcome Measures:
Title
Emotional Threshold Detection Task (ETDT).
Description
A morphing task to assess changes in participants' participants' thresholds to detect changes in the facial expression of emotions.
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
Title
Anagram Stress Task (AST)
Description
Behavioral persistence in trying to solve anagrams with different levels of difficulty
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A score of >13 in the Beck Depression Inventory (BDI-II) Exclusion Criteria: Impaired vision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmelo Vazquez, Ph.D:
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Psychology
City
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25561486
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.
Results Reference
background
PubMed Identifier
24652823
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.
Results Reference
background
PubMed Identifier
22731990
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.
Results Reference
background
PubMed Identifier
22318791
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.
Results Reference
background
PubMed Identifier
25305417
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.
Results Reference
background
PubMed Identifier
23421524
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.
Results Reference
background
PubMed Identifier
20395400
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.
Results Reference
background
PubMed Identifier
27931196
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.
Results Reference
derived

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Attentional Bias Modification Through Eye-tracker Methodology (ABMET)

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