Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-01
Brief Title:
Confirmatory Efficacy Trial of Attention Bias Modification for Depression
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Confirmatory Efficacy Trial of a Traditional vs Gamified Attention Bias Modification for Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1examine 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
Aim 1examine 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 ABMs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None