Effects of Attention Training Interventions on Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions
研究概览
简要总结
The purpose of this study is to study the effects of attention training interventions on symptoms and brain function in major depressive disorder.
详细描述
Attention training programs including mindfulness meditation-based interventions have been shown to be effective for treating depression. Currently the biological and psychological mechanisms of action of attention training for major depression disorder are unknown. The objective of the current study is to improve the investigator's understanding of the mechanisms of attention training interventions for depression.
Research participants will include approximately 165 individuals with major depressive disorder randomized to one of three types of attention training programs. Before and after intervention participants will complete a number of biological assessments including MRI, EEG, behavioral tasks, and questionnaires. The study will be completed across three visits: (1) a screening visit; (2) data collection session 1; and (3) data collection session 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 criteria for major depressive disorder
- •Written informed consent
- •Both biological sexes, any ethnicity
- •Age 18-55
- •Scores exceeding cutoffs on depression questionnaires
- •Right-handed
- •Normal or corrected-to-normal vision and hearing
- •Fluency in written and spoken English
- •Absence of psychotropic medication
排除标准
- •Use of substances or prior treatments that may interfere with study procedures or outcomes (e.g., stimulants, blood pressure medication)
- •Medical conditions that may interfere with study procedures or outcomes (e.g., thyroid disorder)
- •Current therapy and practices overlapping with study interventions
- •Select other DSM-5 disorders and symptoms (e.g., psychotic symptoms, suicidal ideation)
- •Failure to meet MRI safety requirements or suitability
- •Significant inconsistencies in self-report or first-degree relatives with history or current psychotic symptoms
研究组 & 干预措施
attention training intervention 2
14-day smartphone-based audio-guided attention training program with moderate mindfulness influence
干预措施: attention training intervention 2 (Behavioral)
attention training intervention 1
14-day smartphone-based audio-guided attention training program with heavy mindfulness influence
干预措施: attention training intervention 1 (Behavioral)
attention training intervention 3
14-day smartphone-based audio-guided intervention without mindfulness emphasis
干预措施: attention training intervention 3 (Behavioral)
结局指标
主要结局
changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions
时间窗: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
changes in behavioral task performance including related to cognitive processing (e.g., Flanker Task).
时间窗: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
changes in behavioral task performance including related to affective (e.g., Probabilistic Reward Task [PRT])
时间窗: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
changes in questionnaire measures including severity of depression (e.g., Beck Depression Inventory [BDI-II]: minimum/maximum values = 0/63, higher scores indicate worse outcome)
时间窗: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
次要结局
未报告次要终点
研究者
Matthew Sacchet
Assistant Neuroscientist
Mclean Hospital