- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02931487
Restoring Emotion Regulation Networks in Depression Vulnerability
April 25, 2019 updated by: Nils Inge Landrø, University of Oslo
Restoring Emotion Regulation Networks in Depression Vulnerability: An Experimental Study Applying an Attention Bias Modification Procedure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway, 0317
- University of Oslo, Department of Psychology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently no-depressed subjects with a history of major depression.
Exclusion Criteria:
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Attentional Bias Modification
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.
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Computerized
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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.
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Computerized
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD response in prefrontal cortical regions
Time Frame: Two weeks after after ABM-training
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Stronger fMRI BOLD response in prefrontal cortical regions in ABMT compared to neutral AMB placebo condition.
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Two weeks after after ABM-training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD response within the amygdala
Time Frame: Two weeks after ABM-training
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Lower ABM fMRI BOLD response within the amygdala in ABMT compared to neutral ABM placebo condition.
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Two weeks after ABM-training
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DTI
Time Frame: Two weeks after ABM-training
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Increased neural integrity as measured by fractional anisotropy values in the uncinate fasciculi (UF) in the active AMBT compared to neutral ABM placebo condition.
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Two weeks after ABM-training
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RSFC
Time Frame: Two weeks after ABM-training
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Increased integrity within the attentional networks at rest as measured by independent component analysis (ICA) in ABMT compared to neutral ABM training.
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Two weeks after ABM-training
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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.
Time Frame: Two weeks after ABM-training
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The low expressive variant will be associated with more frontal BOLD activation and lower amygdala activation after ABMT
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Two weeks after ABM-training
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BDNF
Time Frame: Two week after ABM-training
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Brain Derived Neurotropic Factor (BDNF) val66met polymorphic variation linked to Brain Derived Neurotropic Factor (BDNF) variation will differentiate between ABMT and neutral AMB placebo as measured by fMRI whole brain BOLD responses.
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Two week after ABM-training
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Serotonergic cumulative genetic score and fMRI
Time Frame: Two weeks after ABM-training
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A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on fMRI BOLD signal compared to a neutral placebo condition.
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Two weeks after ABM-training
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Serotonergic cumulative genetic score and morphompetry
Time Frame: Two weeks after ABM-training
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A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on structural MRI as measured by total grey matter volume compared to a neutral placebo condition.
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Two weeks after ABM-training
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Serotonergic cumulative genetic score and fMRI and DTI
Time Frame: Two weeks after ABM-training
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A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on DTI MRI as measured by fractional anisotropy compared to a neutral placebo condition.
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Two weeks after ABM-training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nils I Landrø, phd, University of Oslo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 8, 2016
First Submitted That Met QC Criteria
October 10, 2016
First Posted (Estimate)
October 13, 2016
Study Record Updates
Last Update Posted (Actual)
April 30, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSØ-2015052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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