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Development of Attention Bias Modification for Depression

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified July 2017 by University of Texas at Austin
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT02880215
First received: August 17, 2016
Last updated: July 18, 2017
Last verified: July 2017
  Purpose
Although negatively biased attention has a central theoretical and empirical role in the maintenance of depression, there are few behavioral treatments that successfully target and improve this deficit. The current proposal builds upon prior work and aims to further develop an attention bias modification intervention. The investigators propose to develop a highly specific intervention that directly targets negative attention bias and the neurobiology that supports it, using cutting-edge cognitive neuroscience to inform treatment development and improve quality of life of patients whose psychopathology is maintained by negative attention bias.

Condition Intervention
Depression Behavioral: Attention Bias Modification Behavioral: Cognitive Control Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Development of Attention Bias Modification for Depression

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Quick Inventory of Depression - Self Report (QIDS-SR) [ Time Frame: Change in QIDS-SR from baseline to Week 4 to measure change in self-reported depression. ]
    16-item self-report measure of depression symptom severity


Secondary Outcome Measures:
  • Mood and Anxiety Symptoms Questionnaire-Short Form (MASQ-SF) [ Time Frame: Change in MASQ-SF from baseline to Week 4 to measure change in self-reported depression. ]
    30-item self-report measure of negative affect symptoms

  • Hamilton Depression Rating Scale - 17 Item (HAMD-17) [ Time Frame: Change in HAMD-17 from baseline to Week 4 to measure change in interviewer-rated depression. ]
    17-item clinician-administered measure of depression symptom severity


Other Outcome Measures:
  • Attention bias (eye tracking) [ Time Frame: Change in attention bias from baseline to Week 4 to measure change in negative attention bias. ]
    Primary ABM treatment target

  • Resting State (fMRI) [ Time Frame: Change in resting state fMRI from baseline to Week 4 to measure change connectivity in frontal-parietal brain circuitry. ]
    Resting state functional connectivity

  • Psychomotor vigilance test (PVT) [ Time Frame: Change in PVT from baseline to Week 4 to measure change in sustained attention. ]
    Behavioral assessment of sustained attention


Estimated Enrollment: 150
Anticipated Study Start Date: August 15, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Bias Modification
Behavioral intervention designed to improved negative attention bias.
Behavioral: Attention Bias Modification
Behavioral intervention designed to decrease negative attention bias.
Experimental: Cognitive Control Training
Behavioral intervention designed to improve sustained attention.
Behavioral: Cognitive Control Training
Behavioral intervention designed to improve sustained attention.
No Intervention: Assessment Only
Assessment only with no active intervention.

Detailed Description:
The overall goal of this project is to continue development of an attention bias modification (ABM) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. The investigators' prior work indicates that attention bias for negative information is associated with the maintenance of depression and that neural circuitry within frontal-parietal brain networks supports biased attention for negative information, thus allowing us to develop specific and targeted interventions that directly alter the neurobiology of negative attention bias. The proposed R33 study builds upon the investigators' prior National Institute of Mental Health (NIMH) funded work (R21MH092430), which examined whether ABM reduces negative attention bias and improves symptoms of depression. Findings indicate that compared to placebo ABM, active ABM reduced negative attention bias and increased resting state connectivity within a neural circuit (i.e., middle frontal gyrus and dorsal anterior cingulate cortex) that supports control over emotional information. Further, change in negative attention bias from pre- to post-ABM was significantly correlated with depression symptom change but only in the active training condition. Importantly, a 40% decrease in symptoms was observed in the active training condition; however, similar symptom reduction was also observed in the "placebo ABM" condition. Exploratory analyses indicated that placebo training may have promoted depression improvement by enhancing sustained attention. Although these preliminary findings are encouraging and demonstrate that ABM successfully alters the treatment target (i.e., negative attention bias), the investigators' prior work is among the first to document efficacy of ABM among adults with clinically significant depression. It is now prudent and necessary to obtain additional efficacy evidence for ABM before moving forward with large-scale clinical trials of ABM for depression. Aim 1 is to conduct a randomized clinical trial among adults with elevated symptoms of depression and a negative attention bias that compares the efficacy of active ABM to cognitive control training and an assessment-only control condition that does not involve any ABM procedures. Aim 2 is to examine whether ABM alters negative attention bias and functional connectivity within frontal-parietal neural circuitry that support negative attention bias. Aim 3 is to identify mechanisms responsible for the putative efficacy of active ABM and cognitive control training. Study Impact: The current project proposes to target and reduce negative attention bias with a novel intervention grounded in basic psychopathology research. The investigators believe this experimental medicine approach will lead to the development of a highly specific and targeted intervention, using cutting-edge cognitive neuroscience to inform treatment development, and improve the quality of life of people whose psychopathology is maintained by negative attention bias.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able and willing to provide informed consent;
  • fluent in English;
  • moderate or greater depression symptoms;
  • attention bias for negative stimuli;
  • stable psychiatric and neurological medication usage.

Exclusion Criteria:

  • meets criteria for current substance use disorder (mild or greater severity), current or past psychotic disorder, bipolar disorder, or schizophrenia;
  • has any medical or physical conditions that would preclude participation in an fMRI study (e.g., orthodontic braces);
  • is currently receiving psychotherapy or electroconvulsive therapy (ECT);
  • current opioid analgesics or systemic corticosteroid use for an acute medical condition or taken as needed;
  • has had suicidal behaviors or significant suicidal ideation within the last six months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880215

Contacts
Contact: Kean J Hsu, PhD (512) 232-2366 mdl@utexas.edu

Sponsors and Collaborators
University of Texas at Austin
National Institute of Mental Health (NIMH)
  More Information

Publications:
Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02880215     History of Changes
Other Study ID Numbers: 201600258
R33MH109600-01A1 ( U.S. NIH Grant/Contract )
Study First Received: August 17, 2016
Last Updated: July 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available upon study completion.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2017