Development of Attention Bias Modification for Depression

NCT02880215 | Completed DMC

• 2 other identifiers: 201600258R33MH109600-01A1
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depression - Self Report (QIDS-SR)

  16-item self-report measure of depression symptom severity

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

Secondary Outcomes (2)

• Mood and Anxiety Symptoms Questionnaire-Short Form (MASQ-SF)

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

• Hamilton Depression Rating Scale - 17 Item (HAMD-17)

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

Other Outcomes (3)

• Attention bias (eye tracking)

  Change in attention bias from baseline to Week 4 to measure change in negative attention bias.

• Resting State (fMRI)

  Change in resting state fMRI from baseline to Week 4 to measure change connectivity in frontal-parietal brain circuitry.

• Psychomotor vigilance test (PVT)

  Change in PVT from baseline to Week 4 to measure change in sustained attention.

Study Arms (3)

Attention Bias Modification

EXPERIMENTAL

Behavioral intervention designed to improved negative attention bias.

Behavioral: Attention Bias Modification

Cognitive Control Training

EXPERIMENTAL

Behavioral intervention designed to improve sustained attention.

Behavioral: Cognitive Control Training

Assessment Only

NO INTERVENTION

Assessment only with no active intervention.

Interventions

Attention Bias Modification BEHAVIORAL

Behavioral intervention designed to decrease negative attention bias.

Attention Bias Modification

Cognitive Control Training BEHAVIORAL

Behavioral intervention designed to improve sustained attention.

Cognitive Control Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mood Disorders Laboratory

Austin, Texas, 78712, United States

Location

Related Publications (2)

• 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.

  PMID: 25894440 RESULT

• 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.

  PMID: 34807657 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of the Institute for Mental Health Research

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2017
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)