NCT02931487

Brief Summary

Selective biases in attention can be modified by a simple computerized technique: The Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be one reason depression recurs, and altering these biases should reduce risk of recurrence. Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not well understood. More research is needed to explore how altering an implicit attentional bias can lead to changes in subjective mood. One possible explanation is that positive attentional biases are an important component of explicit methods of emotion regulation. The ability to effectively regulate one's emotions is a fundamental component of mental health and this ability is impaired in depression. It has also been shown that recovered depressed people spontaneously show a more dysfunctional pattern of emotion regulation as compared to never depressed controls. Supporting this, growing evidence implicates dysregulation of a medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial thalamus. Components of this circuit are reciprocally connected with the amygdala, which is implicated in emotional processing in the healthy brain and dysregulated in depression. Negative emotion processing biases depend on both enhanced "bottom-up" responses to emotionally salient stimuli and reduces "top-down" cognitive control mechanisms, required to suppress responses to emotionally salient but task irrelevant information. Cognitive reappraisal and distancing are common strategies to down- or upregulate emotional responses. Reappraisal is an emotion regulation strategy that involves reinterpretation and changing the way one thinks about an event or stimulus with the goal of changing its affective impact. Distancing is a type of reappraisal that involves creating mental space between oneself and the emotional event in order to see things from a different, less self-focused perspective. It has been shown that distancing is a strategy that people can improve at over time compared to reinterpretation. The neural systems which support the explicit regulation of emotion have previously been characterized and include both lateral- and prefrontal cortex. This frontal activity is predicted to downregulate limbic circuitry involving the amygdala during passive viewing of emotional salient stimuli.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

July 8, 2016

Last Update Submit

April 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • BOLD response in prefrontal cortical regions

    Stronger fMRI BOLD response in prefrontal cortical regions in ABMT compared to neutral AMB placebo condition.

    Two weeks after after ABM-training

Secondary Outcomes (8)

  • BOLD response within the amygdala

    Two weeks after ABM-training

  • DTI

    Two weeks after ABM-training

  • RSFC

    Two weeks after ABM-training

  • 5-HTTLPR + A>G polymorphic variation divided by the triallelic functional "high expressive" versus "low expressive" genotype will moderate the impact from ABMT as measured by whole brain BOLD responses.

    Two weeks after ABM-training

  • BDNF

    Two week after ABM-training

  • +3 more secondary outcomes

Study Arms (2)

Attentional Bias Modification

EXPERIMENTAL

ABM dot-probe task with image stimuli (faces) of three valences: positive (happy), neutral, or negative (angry and fearful). In the ABM condition, probes were located behind positive stimuli in 87 % of the trials (valid trials), as opposed to 13% with probes located behind the more negative stimuli (invalid trials). Consequently, participants should implicitly learn to deploy their attention toward positive stimuli, and in this way develop a more positive AB when completing the task.

Behavioral: Attentional Bias Modification

Sham comparator

SHAM COMPARATOR

Sham condition without modification of attentional bias. These trials are identical in structure to the ABM trials with the exception that target probes replaced negative and positive images with equal frequency.

Behavioral: Sham Comparator

Interventions

Computerized

Attentional Bias Modification
Sham ComparatorBEHAVIORAL

Computerized

Sham comparator

Eligibility Criteria

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

You may qualify if:

  • Currently no-depressed subjects with a history of major depression.

You may not qualify if:

  • Current or past neurological illness, bipolar disorder, psychosis or drug addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo, Department of Psychology

Oslo, 0317, Norway

Location

Related Publications (2)

  • Hilland E, Landro NI ;, Harmer CJ, Browning M, Maglanoc LA, Jonassen R. Attentional bias modification is associated with fMRI response toward negative stimuli in individuals with residual depression: a randomized controlled trial. J Psychiatry Neurosci. 2020 Jan 1;45(1):23-33. doi: 10.1503/jpn.180118.

  • Hilland E, Landro NI, Harmer CJ, Maglanoc LA, Jonassen R. Within-Network Connectivity in the Salience Network After Attention Bias Modification Training in Residual Depression: Report From a Preregistered Clinical Trial. Front Hum Neurosci. 2018 Dec 21;12:508. doi: 10.3389/fnhum.2018.00508. eCollection 2018.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Nils I Landrø, phd

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. philos

Study Record Dates

First Submitted

July 8, 2016

First Posted

October 13, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations