Confirmatory Efficacy Trial of Attention Bias Modification for Depression

Recruiting · NCT06361095 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas at Austin

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Depression

Interventions studied

Gamified Attention Bias ModificationSham Attention Bias ModificationTraditional Attention Bias Modification

What this trial is about

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.

Who can take part

Age range

18 Years to 70 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Early Phase 1

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed across 1 US state.

Institute for Mental Health Research - Austin, Texas, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →