RecruitingEarly Phase 1NCT06361095

Confirmatory Efficacy Trial of Attention Bias Modification for Depression

Confirmatory Efficacy Trial of a Traditional vs. Gamified Attention Bias Modification for Depression

Sponsor

University of Texas at Austin

Enrollment

600 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a computer-based treatment called Attention Bias Modification (ABM) — a type of brain training that shifts how a depressed person's attention focuses on negative versus positive things — as a therapy for depression. Participants complete repeated computerized tasks designed to retrain attention away from negative stimuli. **You may be eligible if...** - You are 18–70 years old - You are fluent in English - You currently have significant depressive symptoms (scoring 13 or higher on the QIDS-SR depression scale) - If you are on antidepressant medication, your dose has been stable for at least 12 weeks **You may NOT be eligible if...** - You have had suicidal behavior or significant suicidal thoughts in the past 6 months - You have a history of bipolar disorder or psychotic disorders - You have had a moderate or severe substance use disorder in the past 12 months - You are currently taking opioid medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTraditional 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.

BEHAVIORALGamified 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.

BEHAVIORALSham 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.