Evaluation of a Therapeutic Mobile App for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire - 8 (PHQ-8)
研究概览
简要总结
The purpose of this study is a preliminary evaluation of a gamified attention bias modification training (GAMBT) for reducing symptoms of depression and rumination. Individuals with elevated symptoms of depression will use the digital intervention over the course of 4 weeks. They will complete a brief (~5 question) survey daily, as well as weekly assessments.
详细描述
This study aims to assess the feasibility and efficacy of the digital therapeutic attention bias modification (ABM) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. Consistent with the experimental therapeutics approach ABM has been shown to both reduce negative attention bias and improve symptoms of depression. However, engagement with these tasks have been mixed, with some participants describing traditional ABM tasks as boring. This had led to the development of gamified versions of ABM with the intent to improve participant engagement. Nevertheless, there have been very few rigorous trials of ABM for depression, and no one to our knowledge has used ecological momentary assessment to tease apart the mechanisms by which ABM can lead to improvements in depression symptoms.
Participants will access the intervention on their mobile smart phone and complete treatment over a period of 4 weeks. Enrolled participants will be randomly assigned to one of two groups: Gamified attention bias modification training, or gamified placebo training. They will complete brief (~5 questions) daily surveys, as well as weekly remote assessments of attention bias and depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able and willing to provide informed consent;
- •fluent in English;
- •normal or corrected-to-normal vision
- •moderate or greater depression symptoms (defined as greater than or equal to 10 on the PHQ-8);
- •attention bias for negative stimuli (operationalized as greater than an average of 6500 ms of dwell time on sad faces in an attention bias task);
- •stable psychiatric and neurological medication usage.
- •access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments
排除标准
- •recent heavy alcohol use defined as a score of 2 or higher on the PDSQ
- •past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.)
- •previous experience with gamified attention bias modification app
研究组 & 干预措施
Gamified Attention Bias Modification
Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias.
干预措施: Gamified Attention Bias Modification (Device)
Gamified Placebo Training
Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias
干预措施: Gamified Placebo Training (Device)
结局指标
主要结局
Patient Health Questionnaire - 8 (PHQ-8)
时间窗: Baseline to Treatment End (4 weeks)
8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)
Patient Health Questionnaire - 8 (PHQ-8)
时间窗: End of treatment (4 week treatment phase)
8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)
次要结局
- Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale(Baseline to Treatment End (4 weeks))
- Ruminative Response Scale - Brooding subscale (RRS-B)(Baseline to Treatment End (4 weeks))
- Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale(Baseline to Treatment End (4 weeks))
- Ruminative Response Scale - Brooding Subscale (RRS-B)(End of treatment (4 week treatment phase))
- Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage From" Subscale(End of treatment (4 week treatment phase))
- Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Subscale(End of treatment (4 week treatment phase))
研究者
Christopher G. Beevers
Professor
University of Texas at Austin