Clinical trial NCT06361095: Confirmatory Efficacy Trial of Attention Bias Modification for Depression
Official title: Confirmatory Efficacy Trial of a Traditional vs. Gamified Attention Bias Modification for Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Depression
Keywords: depression treatment
attention bias modification
digital mental health treatment
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Arcade Therapeutics
First posted: 2024-04-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The overall goal of this project is to conduct a well-powered confirmatory efficacy trial comparing a gamified, attention bias modification (ABM) mobile application and traditional ABM to sham ABM among adults with elevated symptoms of depression. The proposed R01 efficacy trial follows the NIMH intervention development sequence as it builds upon prior NIMH-funded experimental therapeutics work, specifically R21MH092430 "Attention training for Major Depressive Disorder" and R33MH109600 "Development of attention bias modification for depression". This prior work demonstrates that active ABM engages and alters negative attention bias and there is a preliminary efficacy signal that ABM reduces depression. Although traditional ABM is efficacious for the treatment of depression, "gamified" forms of ABM have the potential to be more accessible and engaging than traditional ABM. Pilot work suggests that a gamified ABM can reduce negative affect; however, its effectiveness for depression has not yet been established. Thus, investigators are proposing to conduct a well-powered, confirmatory efficacy trial to determine ABM's potential for the treatment of depression. In Aim 1, the investigators will examine the efficacy of ABM in a large sample of adults (N = 600) with elevated symptoms of depression. The investigators hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than sham ABM. The investigators further hypothesize that traditional ABM will be non-inferior to gamified ABM (treatment superiority between the ABM conditions will also be tested). In Aim 2, the investigators will examine putative moderators and mediators of ABM. Based on ABM research with anxious populations, it is predicted that people with a strong initial attentional bias for sad stimuli will experience greater reductions in depression in response to either gamified or traditional ABM than sham ABM. In terms of mediation, compared to sham ABM, the investigators hypothesize that gamified and traditional ABM will: (1) decrease negative attentional bias measured behaviorally with reliable eye tracking methods; (2) significantly reduce depression; and (3) improve depression symptoms via their influence on negative attentional bias. Selection of the putative mediators is informed by our prior R33 ABM trial, where it was found that gaze bias away from sad stimuli mediated the effect of traditional ABM on depression symptom change. In Aim 3, an exploratory aim, the investigators will estimate the durability of ABM by collecting post-treatment symptom data 1-, 2-, 3-, and 6-months after ABM completion. Symptom change and reliable recovery across a six-month follow-up period will be estimated. Currently, the durability of ABM effects for depression is unknown, as few well-powered ABM studies for depression have obtained follow-up data. This trial would provide the most definitive data to date regarding whether ABM for depression is a promising treatment for depression.

Eligibility criteria: 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

Primary outcomes:
measure: QIDS (Quick Inventory of Depression Symptoms) SR-16
timeFrame: Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Other outcomes:
Locations:
city: Austin
country: United States
facility: Institute for Mental Health Research
state: Texas
Study officials:
affiliation: UT Austin
name: Christopher G Beevers, PhD
role: PRINCIPAL_INVESTIGATOR
References: