Confirmatory Efficacy Trial of Attention Bias Modification for Depression

NCT06361095 | Recruiting Early Phase 1 DMC

• 1 other identifier: R01GABM
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:

• Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM
• Aim 1: establish that gamified ABM is at least as effective as traditional ABM.
• Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.
• Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers. If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression.

Conditions

Depression

Keywords

depression treatment; attention bias modification; digital mental health treatment

Outcome Measures

Primary Outcomes (1)

• QIDS (Quick Inventory of Depression Symptoms) SR-16

  The Quick Inventory of Depressive Symptoms (QIDS) is a 16-item measure (self-report and clinician-rated versions) for adults with depression with solid psychometric properties and substantial data supporting sensitivity to change. The QIDS assesses the criterion domains used to diagnose a major depressive disorder. The participant must score a minimum of 13 on the QIDS-SR at the baseline assessment to qualify for participation. Total QIDS scores range from 0 to 27, with higher scores reflecting greater severity of depression, and thus, worst outcomes for our study.

  Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

Secondary Outcomes (5)

• Sheehan Disability Scale (SDS)

  Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

• Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

• Hamilton Depression Rating Scale (HAM-D)

  Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

• Generalized Anxiety Disorder (GAD-7)

  Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

• Perseverative Thinking Questionnaire (PTQ)

  Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

Study Arms (3)

Sham Attention Bias Modification

SHAM COMPARATOR

Sham and traditional ABM interventions will be identical in all respects with one critical exception. For sham ABM, after stimuli offset the target will appear with equal probability (50%) in the location of the neutral or the dysphoric stimulus.

Behavioral: Sham Attention Bias Modification

Traditional Attention Bias Modification

ACTIVE COMPARATOR

This ABM variant is a web-based program delivered to participants via a computer. It presents pairs of stimuli to the right and left visual fields from two stimulus categories: sad or neutral facial expressions from the Pictures of Facial Affect (POFA) collection and dysphoric or neutral scenes from or from the International Affective Picture System (IAPS) collection.

Behavioral: Traditional Attention Bias Modification

Gamified Attention Bias Modification

EXPERIMENTAL

This ABM variant will be completed on participants' mobile devices (iOS or Android). During app use, they will be presented with sad-happy stimulus pairs followed by target probes (tracing a path) always appearing at the happy stimulus location.

Behavioral: Gamified Attention Bias Modification

Interventions

Traditional Attention Bias Modification BEHAVIORAL

Each ABM trial begins with a central fixation cross for 1500ms, followed by a pair of POFA or IAPS stimuli (see Figure 3). POFA pairs will be presented for 3000ms, while IAPS pairs will be presented for 4500ms (due to the increased image complexity of IAPS images relative to POFA images). Longer stimulus duration times were selected based on evidence that attention biases for sad stimuli are prolonged in depression. Following offset of the images, either a single or double asterisk probe appears in the location of one of the images and will remain until a participant response or 10,000ms. In active ABM, the probe had an 80% probability of appearing in the location of the neutral stimulus. Investigators selected 80% rather than 100% to allow for computing attention bias during training and to facilitate task engagement. At the end of each ABM session, participants are provided feedback regarding their task performance relative to their last five sessions in a visual format.

Traditional Attention Bias Modification

Gamified Attention Bias Modification BEHAVIORAL

Each trial consists of the fixation stage, facial cue stage, and response stage. At the fixation stage, an image appears (a colorful medallion) for 500 ms. The fixation appears randomly within a fixed rectangular field on the user's smartphone screen, and is always at the midpoint between the two face cues that will appear in the next stage. Next, after the cue disappears, two animated faces appear on the screen, one happy and one sad, with a 1000ms duration. Immediately after they disappear, a target probe (a trail) appears in the location of the happy face cue. The path remains (up to 3 seconds) until participants respond by tracing it starting from the point at which the face cue disappeared. They are instructed to quickly but accurately trace the path with their finger and receive visual and haptic feedback during tracing to indicate they are tracing accurately, followed by the path disappearing.

Gamified Attention Bias Modification

Sham Attention Bias Modification BEHAVIORAL

Sham attention bias modification designed to match the active ABM condition in all respects except for the shifting attention away from negative stimuli in active attention bias modification.

Sham Attention Bias Modification

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided informed consent
• Fluent in English
• Scored 13 or greater on the QIDS-SR at the baseline assessment
• Between the ages of 18 to 70
• Have had no changes in medication and dosage in the past 12 weeks (if currently on antidepressant medication)

You may not qualify if:

• Reported suicidal behavior or significant suicidal ideation within the past six months using the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Met criteria for current or past bipolar or psychotic disorders
• Current (i.e., within the past 12 months) substance use disorders of moderate or greater severity on the Mini International Neuropsychiatric Interview (MINI)
• Currently taking opioid analgesics or systemic corticosteroid use as these medications
• Currently receiving psychotherapy

Sponsors & Collaborators

• University of Texas at Austin: lead
• Arcade Therapeutics: collaborator

Study Sites (1)

Institute for Mental Health Research

Austin, Texas, 78705, United States

RECRUITING

Related Publications (1)

• Fadrigon B, Tseng A, Weisenburger RL, Levihn-Coon A, McNamara ME, Shumake J, Smits JAJ, Dennis-Tiwary TA, Beevers CG. Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107797. doi: 10.1016/j.cct.2024.107797. Epub 2024 Dec 24.

  PMID: 39725004 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Christopher G Beevers, PhD

  UT Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher G Beevers, PhD

CONTACT

5124717557; beevers@utexas.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data is expected to become available at the end of the clinical trial (approximately five years from now) with no end date.
• Access Criteria: Qualified researchers, as determined by the NIH's NDAR, will have access to the data.

Locations

US (1)