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

项目总结/摘要 该项目的总体目标是进行一项有效性良好的验证性疗效试验， 注意力偏差修正（ABM）移动的应用程序和传统ABM在成年人中的假ABM 抑郁症症状加重拟议的R 01疗效试验遵循NIMH干预措施的发展 序列，因为它建立在先前的NIMH资助的实验治疗工作，特别是R21 MH 092430 《重性抑郁症的注意力训练》和R33 MH 109600《注意力偏差的发展》 抑郁症的改变”。这项先前的工作表明，积极的反弹道导弹从事和改变消极的 注意力偏差，并且存在ABM减少抑郁症的初步功效信号。虽然传统的ABM 是有效的治疗抑郁症，“游戏化”形式的ABM有可能更容易获得 比传统的反弹道导弹更有吸引力试点工作表明，游戏化的ABM可以减少负面影响; 然而，其对抑郁症的有效性尚未确定。因此，我们建议进行一项 这是一项有效的、确证性的疗效试验，以确定ABM治疗抑郁症的潜力。在目标1中， 我们将在一个大样本的成人（N = 600）中检查ABM的疗效， 萧条我们假设游戏化和传统的ABM将导致更大的减少， 自我报告和采访者评定的抑郁症状比假ABM。我们进一步假设， 传统ABM将不劣于游戏化ABM（我们还将检验 ABM条件）。在目标2中，我们将研究ABM的假定调节者和调解者。基于ABM 通过对焦虑人群的研究，我们预测，对悲伤刺激有强烈初始注意力偏见的人， 与假ABM相比，游戏化或传统ABM对抑郁症的反应更大。 在调解方面，与假ABM相比，我们假设游戏化和传统ABM将：（1） 减少负注意力偏差测量行为与可靠的眼动跟踪方法;（2）显着 （3）通过影响负性注意偏向改善抑郁症状。 我们之前的R33 ABM试验告知了假定介质的选择，在该试验中，我们发现凝视偏差远离 悲伤刺激介导了传统ABM对抑郁症状改变的影响。在目标3中， 探索性目的，我们将通过收集治疗后症状数据1-，2-，3-， 反弹道导弹系统完成后6个月。6个月随访期间的症状变化和可靠恢复 期间将进行评估。目前，ABM对抑郁症影响的持久性尚不清楚， 有效的ABM抑郁症研究已经获得了随访数据。这次审判将提供最多的 关于ABM治疗抑郁症是否是一种有希望的治疗抑郁症的确切数据。

Project Summary/Abstract 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, we are proposing to conduct a well-powered, confirmatory efficacy trial to determine ABM’s potential for the treatment of depression. In Aim 1, we will examine the efficacy of ABM in a large sample of adults (N = 600) with elevated symptoms of depression. We hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than sham ABM. We further hypothesize that traditional ABM will be non-inferior to gamified ABM (we will also test for treatment superiority between the ABM conditions). In Aim 2, we will examine putative moderators and mediators of ABM. Based on ABM research with anxious populations, we predict 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, we 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 we found gaze bias away from sad stimuli mediated the effect of traditional ABM on depression symptom change. In Aim 3, an exploratory aim, we 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.