NCT02847793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

July 22, 2016

Last Update Submit

October 9, 2018

Conditions

Keywords

Attentional Bias Modification (ABM)Cognitive Bias Modification (CBM)DepressionDysphoriaGaze patternsEye-tracking

Outcome Measures

Primary Outcomes (3)

  • Assessment of current mood (PANAS)

    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)

    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)

    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 Outcomes (8)

  • Beck Depression Inventory-II

    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

    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)

    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)

    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

    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.

  • +3 more secondary outcomes

Other Outcomes (2)

  • Emotional Threshold Detection Task (ETDT).

    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)

    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

Study Arms (2)

Gaze training

ACTIVE COMPARATOR

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

Placebo intervention

PLACEBO COMPARATOR

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

Interventions

Gaze trainingBEHAVIORAL

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).

Also known as: Attentional Bias Modification (ABM)
Gaze training

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.

Placebo intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Impaired vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology

Madrid, 28223, Spain

Location

Related Publications (8)

  • 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: 25561486BACKGROUND
  • 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: 24652823BACKGROUND
  • 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: 22731990BACKGROUND
  • 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: 22318791BACKGROUND
  • 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: 25305417BACKGROUND
  • 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: 23421524BACKGROUND
  • 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: 20395400BACKGROUND
  • 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.

MeSH Terms

Conditions

Cognition DisordersDepression

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Carmelo Vazquez, Ph.D:

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Psychopathology

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 28, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

July 28, 2017

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations