Recruiting
Early Phase 1

Gamified ABM vs. Traditional ABM

Sponsor:

University of Texas at Austin

Code:

NCT06361095

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Traditional Attention Bias Modification

Gamified Attention Bias Modification

Sham Attention Bias Modification

Study Details

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

Study ID

NCT06361095

Start date

May 1, 2024

Status verified date

May, 2025

Completion date

May 1, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Attention Bias Modification

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.

active comparator: Traditional Attention Bias Modification

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.

experimental: Gamified Attention Bias Modification

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.

Interventions

Traditional Attention Bias Modification

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.

Gamified Attention Bias Modification

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.

Sham Attention Bias Modification

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.

Primary outcome measure

  • QIDS (Quick Inventory of Depression Symptoms) SR-16 [ Time Frame: Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period) ]

Central Contacts and Locations

Central contacts

Christopher G Beevers, PhD

5124717557beevers@utexas.edu

Locations

Institute for Mental Health Research

Recruiting

Austin, Texas, United States, 78705

Contacts

Christopher G Beevers, PhD

beevers@utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Sep 15, 2025

Last verified

May, 2025

Keywords

  • depression treatment
  • attention bias modification
  • digital mental health treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-09-15.