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Neuroplasticity in an Extended Amygdala Network as a Target Mechanism for Attention Bias Modification Outcome

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ClinicalTrials.gov Identifier: NCT03092609
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Northern Michigan University

Brief Summary:
Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is an increased attentional bias to threat, which has been identified as a causal contributor in the development of anxiety. Given this causal relationship, attention bias modification was introduced as a treatment option where anxiety is reduced by training individuals to direct their attention away from threat and thereby decreasing anxiety. Over a decade of research using this approach, called attention bias modification (ABM), suggests that overall the approach is effective in reducing anxiety. Although ABM appears to be a very promising treatment option for anxiety, there are several factors limiting the effectiveness of ABM. These include the recognition of individual-level needs and a known underlying mechanism of action by which ABM is effective. Neuroimaging evidence suggests that attentional bias to visual threat is associated with a network of brain regions including the amygdala, anterior cingulate cortex, and visual cortex. In human participants, experience-dependent neuroplasticity is visible in voxel-based morphometry based measures of gray matter volume following training. Recently, voxel-based morphometry measures of gray matter volume have been linked to dendritic spine density—a known cellular mechanism for learning-related neuroplasticity. Thus, voxel-based morphometry measures are ideally suited to measure learning-related neuroplasticity following attention bias modification. In this proposal participants' level of attentional bias, anxiety, and gray matter volume will be measured before and after completing six weeks of attention bias modification training (N = 50) or attention control training (N= 50). The proposal aims to (1) establish that pre-treatment bias predicts variability in gray matter volume in the extended amygdala and anterior cingulate cortex, (2) assess the extent to which reduced extended amygdala and anterior cingulate cortex gray matter volume following ABM underlies reductions in attentional bias and anxiety, and (3) Establish pre-treatment bias as a predictor of successful ABM as measured by reduced bias, reduced anxiety, and reduced gray matter volume in the extended amygdala and anterior cingulate cortex. Consistent with the objectives of the AREA grant and NIMH's focus on identifying and validating new targets for treatment development that underlie disease mechanisms, the current proposal plans to involve students at a rural primarily undergraduate university in a research project aimed at establishing neuroplasticity in the extended amygdala and anterior cingulate cortex as a target mechanism for ABM training outcome, which could be used to objectively track training-related outcomes in anxiety treatment.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Attention Bias Modification Behavioral: Attention Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neuroplasticity in an Extended Amygdala Network as a Target Mechanism for Attention Bias Modification Outcome
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : September 14, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Attention Bias Modification Behavioral: Attention Bias Modification
Attention bias modification (ABM) sessions will consist of a modified dot-probe task that only contains incongruent trials (i.e., target-dot - neutral stimulus 100% pairing).

Active Comparator: Attention Control Behavioral: Attention Control
Attention control (AC) sessions, will consist of a standard dot-probe task (i.e., target-dot - neutral/threat stimulus 50% pairing). Thus, for AC participants, bias should remain the same, while ABM participants should show a reduced bias to threat.




Primary Outcome Measures :
  1. Attentional Bias [ Time Frame: Baseline and after 6 weeks of the intervention ]
    Reaction time difference to congruent and incongruent trials in the dot-probe task, which measure heightened attentional bias to threat.


Secondary Outcome Measures :
  1. State and Trait Anxiety [ Time Frame: Baseline and after 6 weeks of the intervention ]
    Anxiety as measured by the Speilberger State-Trait Anxiety Inventory


Other Outcome Measures:
  1. MRI measures of gray matter volume [ Time Frame: Baseline and after 6 weeks of the intervention ]
    T1-weighted MRI measures of gray matter volume

  2. MRI measures of structural and functional connectivity [ Time Frame: Baseline and after 6 weeks of the intervention ]
    Diffusion-tensor weighted MRI based measures of structural connectivity and functional MRI based measures of functional connectivity.



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Handedness (right handed)
  • Normal Vision
  • High Anxiety
  • Preexisting Attentional Bias

Exclusion Criteria:

  • No MRI contraindications
  • No History of Head Injury
  • No Neurological History
  • Psychological History
  • Limited Recreational Drug Use, No Abuse
  • Limited Prescription Drug Use, No Abuse
  • No Claustrophobia
  • Not Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092609


Contacts
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Contact: Lin Fang, PhD 906-227-2954 lfang@nmu.edu

Locations
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United States, Michigan
Northern Michigan University Recruiting
Marquette, Michigan, United States, 49855
Contact: Lin Fang, PhD    906-227-2954    lfang@nmu.edu   
Sponsors and Collaborators
Northern Michigan University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Joshua M Carlson, PhD Northern Michigan University

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Responsible Party: Northern Michigan University
ClinicalTrials.gov Identifier: NCT03092609     History of Changes
Other Study ID Numbers: HS13-555
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be uploaded to the NIMH Data Archive

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northern Michigan University:
Attentional Bias to Threat