Mobile Cognitive Behavioral Therapy for Stroke
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 assess the feasibility and acceptability of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in adults who have had a stroke.
详细描述
The primary objective of this study is to assess the feasibility and acceptability of "MAYA", a mobile CBT application, in adults who have had a stroke. Feasibility will be measured by the total number of sessions completed and acceptability will be measured by scores on the Mobile Application Rating Scale-User Version (uMARS). Qualitative feedback will also be collected with a questionnaire using open-ended questions.
A secondary objective will be to evaluate preliminary efficacy of the mobile CBT application on symptoms of depression and anxiety assessed using (1) interview-based measures (the Montgomery Asberg Depression Rating Scale [MADRS] and the Hamilton Anxiety Rating Scale [HAM-A]), and (2) a patient reported outcome measure (the 21-item Depression, Anxiety, and Stress Scale [DASS]).
This study will collect pilot data over the course of 8 weeks. Because this is a pilot study, all participants will use the same version of the app and there will be no control group. Primary outcome measures will be collected at baseline (pre-intervention) and at the endpoint (week 8). Participants will be asked to use the mobile app for at least two days a week, for 30 minutes on each day, for 8 weeks. Participants will have weekly check-ins in person or via a HIPAA compliant virtual meeting platform (Zoom) with a study staff member to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms.
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
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-79
- •Presence of clinically-significant anxiety and/or depression (as determined by an eligibility evaluation)
- •Stroke that occurred 1 month or more prior to study initiation
- •Capacity to provide consent
- •No greater than mild cognitive difficulties based on an eligibility evaluation conducted as part of the study
- •If taking medication for depression and/or anxiety, must be on a stable dose for a minimum of 8 weeks prior to study initiation
- •Ability to use iPhone or iPad independently
- •Home internet access
- •Willingness to participate in the full study duration.
排除标准
- •Aphasia of moderate or greater severity (as determined during an eligibility evaluation)
- •Non-fluency in English
- •History of a bipolar or psychotic disorder
- •Current alcohol or substance use disorder
- •Active suicidal ideation
- •Current engagement in psychotherapy is not grounds for exclusion unless the individual's psychotherapy is primarily focused on CBT
- •Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the study doctor, which warrants a higher level of care and/or immediate referral to psychiatric services
- •Any other clinical or medical reason in the study doctor's initial screening evaluation that suggests the study is not appropriate for the participant
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 8 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.
Number of Sessions completed over study time period
时间窗: Week 1 to Week 8 (8 week treatment)
To assess the feasibility of "MAYA" in adults who have had a stroke, by assessing the number of sessions completed.
Qualitative Interview
时间窗: Week 8 of treatment
This is a series of questions with open-ended responses that are designed to ask participants about their experience using the app and completing the CBT program. There is no numerical scoring; responses are evaluated qualitatively to explore engagement with the app.
次要结局
- Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)(Baseline, Week 4, and Week 8 of treatment (8 week treatment))
- Change in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A)(Baseline, Week 4, and Week 8 of treatment (8 week treatment))
- Change in depression, anxiety, and stress, as measured by the Depression, Anxiety, and Stress Scale (DASS)(Baseline, Week 4, and Week 8 of treatment (8 week treatment))