Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Quality of Life in Neurological Disorders (NeuroQoL) Anxiety short form
研究概览
简要总结
The purpose of this study is to assess preliminary efficacy of a tailored cognitive bias modification for interpretation (CBM-I) app for reducing anxiety in Huntington's disease and Parkinson's disease.
详细描述
The investigators will conduct a pilot randomized controlled trial of the MindTrails-Movement CBM-I app in patients with Huntington's disease and Parkinson's disease (N=136). Participants randomly assigned to the intervention group (N=68) will be asked to download the MindTrails-Movement mobile app and to complete daily CBM-I training sessions and nightly surveys, in addition to surveys at baseline and every 2 weeks for the duration of the 6-week intervention and at 4-week follow-up (week 10).
Participants assigned to the waitlist control group will download a control version of the app without CBM-I training sessions. They will be asked to complete surveys in the app at baseline and every 2 weeks for the duration of the 6-week intervention and at 4-week follow-up (week 10). After 10 weeks, they will be offered the opportunity to access the version of MindTrails-Movement with CBM-I training content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)
- •With anxiety symptoms (NeuroQoL Anxiety ≥12)
排除标准
- •Cognitive decline precluding ability to consent or complete the intervention (MoCA 5 min/telephone ≤11)
- •Unable to read and understand English
- •Does not have regular access to an internet-connected device, capable of downloading and installing the mobile application (i.e., tablet or iPhone running iOS 10 or later or an Android phone running Android 5.0 or later)
- •Not located in the USA
- •<21 years old
- •Active suicidality based on the answer "yes" to questions 4, 5, or 6b of the Columbia-Suicide Severity Rating Scale (Screen version)
研究组 & 干预措施
MindTrails-Movement CBM-I Condition
The intervention group (N=68) will include participants with Huntington's disease (N=34) and Parkinson's disease (N=34). Participants will download the MindTrails-Movement app with active CBM-I training condition and will be prompted to complete brief, daily CBM-I training sessions for a period of 6 weeks. They will complete surveys assessing mood symptoms and interpretation bias at baseline, end of week 2, end of week 4, and end of week 6 (end of intervention), then again at the end of week 10.
干预措施: MindTrails-Movement (Behavioral)
Waitlist Control Condition
The waitlist control group (N=68) will include participants with Huntington's disease (N=34) and Parkinson's disease (N=34). Participants will be asked to download a control version of the app that includes access to a list of support resources but does not include daily CBM-I training content. They will complete surveys assessing mood symptoms and interpretation bias at baseline, end of week 2, end of week 4, and end of week 6, and end of week 10. Waitlist control participants will be offered the opportunity to complete the intervention version of the app after they complete their final study assessments.
干预措施: Waitlist Control (Other)
结局指标
主要结局
Quality of Life in Neurological Disorders (NeuroQoL) Anxiety short form
时间窗: From baseline to end of week 6
Patient-reported anxiety symptoms will be measured using the Quality of Life in Neurological Disorders Anxiety short form (NeuroQoL-Anxiety) total raw scores. This measure includes 8 items ranked 1-5, where the total score is the sum of item scores (range 8-40), and higher scores indicate worse anxiety symptoms.
次要结局
- Movement Disorders Interpretation Bias Scale (MDIB)(From baseline to end of week 6)
- Movement Disorders Interpretation Bias Scale (MDIB)(From baseline to end of week 6)
- Parkinson Anxiety Scale (PAS)(From baseline to end of week 6)
- Brief Body Sensations Interpretation Questionnaire (BBSIQ)(From baseline to end of week 6)
研究者
Jessie Gibson, PhD, RN
Assistant Professor
University of Virginia