Restoring Emotion Regulation Networks in Depression Vulnerability
1 other identifier
interventional
134
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 30, 2019
April 1, 2019
1.6 years
July 8, 2016
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
EXPERIMENTALABM 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.
Sham comparator
SHAM COMPARATORSham 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.
Interventions
Eligibility Criteria
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
- University of Oslolead
- Oslo University Hospitalcollaborator
- University of Oxfordcollaborator
Study Sites (1)
University of Oslo, Department of Psychology
Oslo, 0317, Norway
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.
PMID: 31397551DERIVEDHilland 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.
PMID: 30622463DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nils I Landrø, phd
University of Oslo
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