Confirmatory Efficacy Trial of Attention Bias Modification for Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361095
• Other study ID #: R01GABM
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 1, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: April 2024
• Source: University of Texas at Austin
• Contact: Christopher G Beevers, PhD
• Phone: 5124717557
• Email: beevers[@]utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Institute for Mental Health Research	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Arcade Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QIDS (Quick Inventory of Depression Symptoms) SR-16	The Quick Inventory of Depressive Symptoms (QIDS) is a 16-item measure (self-report and clinician-rated versions) for adults with depression with solid psychometric properties and substantial data supporting sensitivity to change. The QIDS assesses the criterion domains used to diagnose a major depressive disorder.; The participant must score a minimum of 13 on the QIDS-SR at the baseline assessment to qualify for participation. Total QIDS scores range from 0 to 27, with higher scores reflecting greater severity of depression, and thus, worst outcomes for our study.	Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary	Sheehan Disability Scale (SDS)	Self-report measure of symptom-related disability. SDS total score ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores mean a worse outcome.	Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary	Snaith-Hamilton Pleasure Scale (SHAPS)	Self-report measure of anhedonia severity. SHAPS total score ranges from 0 to 14, with higher scores meaning worse outcomes.	Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary	Hamilton Depression Rating Scale (HAM-D)	Interviewer-rated measure of depression symptom severity. Scoring for this assessment can range from a minimum total score of 0 (least severe) and a maximum score of 52 (most severe). Higher scores mean worse outcomes.	Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary	Generalized Anxiety Disorder (GAD-7)	Self-report measure of anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21, with higher scores indicating worse outcomes.	Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary	Perseverative Thinking Questionnaire (PTQ)	A content-independent measures of repetitive negative thinking. PTQ total score for 15 items ranges from 0 to 60, with higher scores indicating worse outcomes.	Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)