Confirmatory Efficacy Trial of Attention Bias Modification for Depression

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Arcade Therapeutics

  collaborator UNKNOWN

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Christopher G Beevers, PhD · UT Austin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2027-11-30

Completion

2028-05-01

Countries

• United States

Study Locations