Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-22 @ 3:02 PM
Study NCT ID:
NCT02847793
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2016-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attentional Bias Modification Through Eye-tracker Methodology (ABMET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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', 'description': "A morphing task to assess changes in participants' participants' thresholds to detect changes in the facial expression of emotions."}, {'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', 'description': 'Behavioral persistence in trying to solve anagrams with different levels of difficulty'}], 'primaryOutcomes': [{'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', 'description': 'A scale measuring current general positive and negative mood'}, {'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.', 'description': 'A scale measuring current anger, happiness, anxiety and depressed mood'}, {'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', 'description': 'An eye-tracking task to measure gaze patterns towards emotional faces'}], 'secondaryOutcomes': [{'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', 'description': 'Symptoms of depression'}, {'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.', 'description': 'Symptoms of anxiety'}, {'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', 'description': 'Ruminative style'}, {'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.', 'description': 'Tendency to suppress distressing thoughts and images'}, {'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.', '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'}, {'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.', 'description': 'Integrative measure of well-being'}, {'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.', 'description': 'Life satisfaction'}, {'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.', 'description': 'Dispositional optimism'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attentional Bias Modification (ABM)', 'Cognitive Bias Modification (CBM)', 'Depression', 'Dysphoria', 'Gaze patterns', 'Eye-tracking'], 'conditions': ['Cognitive Deficits', 'Depression', 'Alteration of Cognitive Function']}, 'referencesModule': {'references': [{'pmid': '25561486', 'type': 'BACKGROUND', '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.'}, {'pmid': '24652823', 'type': 'BACKGROUND', '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.'}, {'pmid': '22731990', 'type': 'BACKGROUND', '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."}, {'pmid': '22318791', 'type': 'BACKGROUND', '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.'}, {'pmid': '25305417', 'type': 'BACKGROUND', '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.'}, {'pmid': '23421524', 'type': 'BACKGROUND', '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.'}, {'pmid': '20395400', 'type': 'BACKGROUND', '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.'}, {'pmid': '27931196', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).\n\nRecent 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.', 'detailedDescription': "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.\n\nAlthough 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A score of \\>13 in the Beck Depression Inventory (BDI-II)\n\nExclusion Criteria:\n\n* Impaired vision'}, 'identificationModule': {'nctId': 'NCT02847793', 'acronym': 'ABMET', 'briefTitle': 'Attentional Bias Modification Through Eye-tracker Methodology (ABMET)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Changes in Selective Attentional Patterns Towards Emotional Stimuli by Using Eye-tracking Techniques: A New Intervention for Depression', 'orgStudyIdInfo': {'id': 'PSI2014-61764-EXPLORA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gaze training', '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', 'interventionNames': ['Behavioral: Gaze training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo intervention', '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)', 'interventionNames': ['Behavioral: Placebo intervention']}], 'interventions': [{'name': 'Gaze training', 'type': 'BEHAVIORAL', 'otherNames': ['Attentional Bias Modification (ABM)'], '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).', 'armGroupLabels': ['Gaze training']}, {'name': 'Placebo intervention', 'type': 'BEHAVIORAL', '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.", 'armGroupLabels': ['Placebo intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28223', 'city': 'Madrid', 'country': 'Spain', 'facility': 'School of Psychology', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carmelo Vazquez, Ph.D:', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Economía y Competitividad, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Psychopathology', 'investigatorFullName': 'Carmelo Vázquez', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}