Advancing Our Understanding and Treatment of Anxiety Through Bringing Together Facets of Conscious Experience and Brain Mechanisms: Open/Closed Meets the Default Mode Network
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Change in GAD - 7
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.
详细描述
The main question[s] it aims to answer are:
PRIMARY AIM: Confirm that the conscious experience of open/closed correlates with P/PCC activation/deactivation.
SECONDARY AIM: Determine if changes in P/PCC activity predict clinical outcomes (GAD-7 scores) in individuals with moderate to severe anxiety after using an app.
Participants may be asked to:
- Complete a Zoom interview
- Complete online surveys at baseline and 2 months post-treatment initiation
- Complete MRIs at baseline and 2 months post-treatment initiation
- Wear a smartwatch and answer daily questions about their anxiety
- Use an app daily
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 65 years
- •Able to travel to Brown University for research assessment
- •Able to speak English because all study activities will be conducted in English.
- •Owns a smartphone
排除标准
- •If using psychotropic medication - not on a stable dosage at least 6 weeks
- •As needed (i.e., prn) benzodiazepine use
- •Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
- •MRI contraindications
- •Claustrophobia
- •Recreational drug use past 2 weeks
- •Alcohol abuse
- •Pregnancy or plans to become pregnant
- •Cohabiting with a study participant
- •Weight ≥ 300 lbs (due to inability to fit in scanner)
研究组 & 干预措施
App-Delivered Mindfulness Training (MT)
The program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment.
干预措施: App-Delivered Mindfulness Training (MT) (Behavioral)
App-Delivered Coloring
An app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies.
干预措施: App-Delivered Coloring (Behavioral)
结局指标
主要结局
Change in GAD - 7
时间窗: collected at baseline and 2 month follow up apt
Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).
Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal
时间窗: collected at baseline and 2 month follow up apt
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
次要结局
- Penn State Worry Questionnaire (PSWQ)(collected at baseline and 2 month follow up apt)
- Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale(collected at baseline and 2 month follow up apt)