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DepressionNCT02880215

Development of Attention Bias Modification for Depression

A study testing Attention Bias Modification in people with Depression, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Depression
What is being tested?
Attention Bias Modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteUnited States
Study dates
1 Sep 2017to 26 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mood Disorders Laboratory

    Austin, Texas, 78712

Other trials in United States

About this study

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.

Read the 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.

Conditions
Depression
Being tested
Attention Bias Modification, Cognitive Control Training
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attention Bias ModificationBehavioural

    Behavioral intervention designed to decrease negative attention bias.

  • Cognitive Control TrainingBehavioural

    Behavioral intervention designed to improve sustained attention.

Study groups in NCT02880215
Study groupRoleWhat they receive
Attention Bias ModificationExperimentalBehavioral intervention designed to improved negative attention bias.
Receives: Behavioral: Attention Bias Modification
Cognitive Control TrainingExperimentalBehavioral intervention designed to improve sustained attention.
Receives: Behavioral: Cognitive Control Training
Assessment OnlyNo interventionAssessment only with no active intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quick Inventory of Depression - Self Report (QIDS-SR)

    16-item self-report measure of depression symptom severity

    Measured: Change in QIDS-SR from baseline to Week 4 to measure change in self-reported depression.

Secondary outcomes (2)
  1. Mood and Anxiety Symptoms Questionnaire-Short Form (MASQ-SF)

    30-item self-report measure of negative affect symptoms

    Measured: Change in MASQ-SF from baseline to Week 4 to measure change in self-reported depression.

  2. Hamilton Depression Rating Scale - 17 Item (HAMD-17)

    17-item clinician-administered measure of depression symptom severity

    Measured: Change in HAMD-17 from baseline to Week 4 to measure change in interviewer-rated depression.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study start1 Sep 2017
  3. Primary completion26 Sep 2019
  4. Study completion26 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880215
Sponsor's protocol ID
201600258
Other IDs
R33MH109600-01A1
Status last verified
Oct 2019
First submitted
17 Aug 2016
Last updated
16 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be made available upon study completion.

Publications

  • 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.

    PubMed 25894440
  • 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.

    PubMed 34807657

Questions about this trial

What is this clinical trial studying?

A study testing Attention Bias Modification in people with Depression, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880215, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.

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