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

传统与游戏化注意力偏差修正治疗抑郁症的验证疗效试验

• 批准号: 10726299
• 负责人: CHRISTOPHER G BEEVERS
• 金额: $ 71.43万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-20 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10726299
• 关键词: Adult; Aftercare; Area; Attention; Basic Science; Clinical Trials; Cognitive; Data; Data Analytics; Depressed mood; Development; Effectiveness; Funding; Goals; Intervention; Interviewer; Investigational Therapies; Literature; Maintenance; Major Depressive Disorder; Measures; Mediating; Mediation; Mediator; Mental Depression; Mental Health; Methods; Modification; National Institute of Mental Health; Outcome; Patient Self-Report; Persons; Population; Protocols documentation; Psychopathology; Public Health; Publishing; Quality of life; Recovery; Reporting; Research; Role; Sampling; Severities; Signal Transduction; Stimulus; Symptoms; Testing; Training; Treatment Protocols; Work; anxious; attentional bias; behavior measurement; cognitive training; confirmatory trial; depressive symptoms; efficacious treatment; efficacy evaluation; efficacy testing; efficacy trial; experience; follow-up; gaze; improved; insight; mobile application; negative affect; prevent; psychosocial; randomized, clinical trials; reduce symptoms; response; sustained attention; symptom treatment; therapy development; trial comparing; visual tracking

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.

项目摘要/摘要 该项目的总体目标是进行一项功能良好的确认效率试验，以比较游戏化的， 注意偏见修改（ABM）移动应用程序和传统的ABM对成年人的假ABM 抑郁症状升高。拟议的R01效率试验遵循NIMH干预开发 序列建立在先前的NIMH资助的实验疗法工作的基础上，特别是R21MH092430 “重度抑郁症的注意力训练”和R33MH109600“注意力偏见的发展 抑郁症的修改”。这项先前的工作表明，主动ABM参与并改变了负面 注意偏见，并且有一个初步的有效性信号，可减少抑郁症。虽然传统的ABM 对于抑郁症的治疗是有效的，“加油化”的ABM形式有可能更容易获得 比传统的ABM引人入胜。飞行员工作表明，游戏ABM可以减少负面影响。 但是，尚未确定其抑郁症的有效性。那，我们建议进行 驱动良好的确认效率试验，以确定ABM对抑郁症治疗的潜力。在AIM 1中， 我们将检查大量成人样本（n = 600）的ABM效率 沮丧。我们假设Gamidived和传统的ABM将导致更大的减少 比假ABM自我报告和访谈者评价的抑郁症状。我们进一步假设 传统的ABM将不属于Gamiified ABM（我们还将测试 ABM条件）。在AIM 2中，我们将检查ABM的假定主持人和调解人。基于ABM 我们对焦虑人群的研究预测，对SAD Stimulli的最初注意偏见的人将 与假ABM相比，对游戏或传统ABM的抑郁症的减少更大。 在调解方面，与Sham ABM相比，我们假设Gamidivided和传统ABM将：（1） 通过可靠的眼动追踪方法在行为上测量的负面注意力偏差降低； （2）显着 减少抑郁症； （3）通过影响负注意偏见来改善抑郁症状。 我们先前的R33 ABM试验向选择的调解员选择，我们发现凝视偏见 从SAD刺激中介导了传统ABM对抑郁症状改变的影响。在AIM 3中 探索目的，我们将通过收集治疗后症状数据1-，2-，3-，， ABM完成后6个月。在六个月的随访中，症状改变和可靠的恢复 时期将被估算。目前，ABM效应对抑郁症的耐用性尚不清楚，因为很少 抑郁症的ABM驱动良好的研究已获得随访数据。该试验将提供最多的 迄今为止，关于抑郁症的ABM是否是抑郁症的承诺治疗的确定性数据。