search
Back to results

Development of Attention Bias Modification for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification
Cognitive Control Training
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mood Disorders Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Attention Bias Modification

Cognitive Control Training

Assessment Only

Arm Description

Behavioral intervention designed to improved negative attention bias.

Behavioral intervention designed to improve sustained attention.

Assessment only with no active intervention.

Outcomes

Primary Outcome Measures

Quick Inventory of Depression - Self Report (QIDS-SR)
16-item self-report measure of depression symptom severity

Secondary Outcome Measures

Mood and Anxiety Symptoms Questionnaire-Short Form (MASQ-SF)
30-item self-report measure of negative affect symptoms
Hamilton Depression Rating Scale - 17 Item (HAMD-17)
17-item clinician-administered measure of depression symptom severity

Full Information

First Posted
August 17, 2016
Last Updated
October 14, 2019
Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02880215
Brief Title
Development of Attention Bias Modification for Depression
Official Title
Development of Attention Bias Modification for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
September 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Bias Modification
Arm Type
Experimental
Arm Description
Behavioral intervention designed to improved negative attention bias.
Arm Title
Cognitive Control Training
Arm Type
Experimental
Arm Description
Behavioral intervention designed to improve sustained attention.
Arm Title
Assessment Only
Arm Type
No Intervention
Arm Description
Assessment only with no active intervention.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification
Intervention Description
Behavioral intervention designed to decrease negative attention bias.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Control Training
Intervention Description
Behavioral intervention designed to improve sustained attention.
Primary Outcome Measure Information:
Title
Quick Inventory of Depression - Self Report (QIDS-SR)
Description
16-item self-report measure of depression symptom severity
Time Frame
Change in QIDS-SR from baseline to Week 4 to measure change in self-reported depression.
Secondary Outcome Measure Information:
Title
Mood and Anxiety Symptoms Questionnaire-Short Form (MASQ-SF)
Description
30-item self-report measure of negative affect symptoms
Time Frame
Change in MASQ-SF from baseline to Week 4 to measure change in self-reported depression.
Title
Hamilton Depression Rating Scale - 17 Item (HAMD-17)
Description
17-item clinician-administered measure of depression symptom severity
Time Frame
Change in HAMD-17 from baseline to Week 4 to measure change in interviewer-rated depression.
Other Pre-specified Outcome Measures:
Title
Attention bias (eye tracking)
Description
Primary ABM treatment target
Time Frame
Change in attention bias from baseline to Week 4 to measure change in negative attention bias.
Title
Resting State (fMRI)
Description
Resting state functional connectivity
Time Frame
Change in resting state fMRI from baseline to Week 4 to measure change connectivity in frontal-parietal brain circuitry.
Title
Psychomotor vigilance test (PVT)
Description
Behavioral assessment of sustained attention
Time Frame
Change in PVT from baseline to Week 4 to measure change in sustained attention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mood Disorders Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available upon study completion.
Citations:
PubMed Identifier
25894440
Citation
Beevers CG, Clasen PC, Enock PM, Schnyer DM. Attention bias modification for major depressive disorder: Effects on attention bias, resting state connectivity, and symptom change. J Abnorm Psychol. 2015 Aug;124(3):463-75. doi: 10.1037/abn0000049.
Results Reference
result
PubMed Identifier
34807657
Citation
Beevers CG, Hsu KJ, Schnyer DM, Smits JAJ, Shumake J. Change in negative attention bias mediates the association between attention bias modification training and depression symptom improvement. J Consult Clin Psychol. 2021 Oct;89(10):816-829. doi: 10.1037/ccp0000683.
Results Reference
derived

Learn more about this trial

Development of Attention Bias Modification for Depression

We'll reach out to this number within 24 hrs