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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

Tracking Information
First Submitted Date  ICMJE March 14, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date September 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03092609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
State and Trait Anxiety [ Time Frame: Baseline and after 6 weeks of the intervention ]
Anxiety as measured by the Speilberger State-Trait Anxiety Inventory
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2017)
  • MRI measures of gray matter volume [ Time Frame: Baseline and after 6 weeks of the intervention ]
    T1-weighted MRI measures of gray matter volume
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Neuroplasticity in an Extended Amygdala Network as a Target Mechanism for Attention Bias Modification Outcome
Official Title  ICMJE Neuroplasticity in an Extended Amygdala Network as a Target Mechanism for Attention Bias Modification Outcome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Experimental: Attention Bias Modification
    Intervention: Behavioral: Attention Bias Modification
  • Active Comparator: Attention Control
    Intervention: Behavioral: Attention Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 14, 2020
Estimated Primary Completion Date September 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lin Fang, PhD 906-227-2954 lfang@nmu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03092609
Other Study ID Numbers  ICMJE HS13-555
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be uploaded to the NIMH Data Archive
Responsible Party Northern Michigan University
Study Sponsor  ICMJE Northern Michigan University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Joshua M Carlson, PhD Northern Michigan University
PRS Account Northern Michigan University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP