Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS)
研究概览
简要总结
This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.
详细描述
The focus of the present study is neuropsychiatric symptoms (i.e., depression, apathy, and anxiety) in individuals who experienced a stroke. Post-stroke neuropsychiatric symptoms are highly prevalent and are associated with diminished quality of life, caregiver distress, and poorer functional capacity and stroke recovery.
The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) application. The app includes modules with educational content and practice of strategies that address the following: (1) education about mood symptoms post-stroke and their association with recovery/rehabilitation; (2) mindfulness, relaxation, and distress tolerance skills; (3) increasing awareness of thinking errors and reframing negative thoughts; and (4) self-compassion, gratitude, and ways to promote resilience during stroke recovery and rehabilitation. The app includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. For the current study, app language and examples will be adapted for individuals with stroke. Participants will be asked to use the app for 3 days per week over a 5-week period, for ~20 minutes in each use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-79
- •Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score >= 8) and/or HADS-A (anxiety, score >= 8).
- •Stroke that occurred within 1 month prior to study initiation.
- •Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC)
- •Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties
- •Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team)
- •Able to adhere to all study requirements and willingness to participate in the full study duration
排除标准
- •Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care
- •Non-fluency in English
- •History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review)
- •Active suicidal ideation requiring a higher level of care
- •Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services
- •Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant
研究组 & 干预措施
Intervention Arm Using the Mobile Cognitive Behavioral Therapy App
The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) mobile application. The app includes modules with educational content and practice of strategies that address post-stroke depression, anxiety, and emotional difficulties.
干预措施: Mobile Cognitive Behavioral Therapy App (Device)
结局指标
主要结局
Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS)
时间窗: Week 5 of treatment
Feasibility and acceptability will be measured by the scores collected on the uMARS by assessing the sub scores of Engagement, Functionality, Aesthetics, and Information of the app to measure the perceived quality of the app. The outcome is the mean of the individual items, ranging from 1 to 5, with 1 denoting minimal satisfaction/rating of app quality and 5 denoting maximum satisfaction and highest rating of app quality
Percent of Sessions completed over study time period
时间窗: From Week 1 to Week 5 of treatment
Feasibility will be assessed by the percentage of possible sessions completed
Percent of homework exercises completed
时间窗: From Week 1 to Week 5 of treatment
Feasibility will be assessed by the percentage of assigned homework exercises that are completed
次要结局
- Mean change from baseline to week 3 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, Week 3)
- Mean change from baseline to week 5 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, Week 5)
- Mean change from baseline to week 3 in coping self-efficacy as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE)(Baseline, Week 3)
- Mean change from baseline to week 5 in coping self-efficacy as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE)(Baseline, Week 5)
研究者
Abhishek Jaywant
Principal Investigator
Weill Medical College of Cornell University