Feasibility and Acceptability of a Mobile Cognitive Behavior Therapy App Targeting Depression and Anxiety in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
研究概览
简要总结
This study aims to assess a mobile app called MAYA for use in middle-aged and older adults with anxiety or mood disorders. The MAYA app is designed to teach coping skills for anxiety and depression that are drawn from cognitive behavioral therapy. Participants will be asked to use the app for at least two days a week, 20 minutes on each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up). During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app. The main hypotheses of the study are that participants will complete most of the assigned sessions and that they will rate their impressions of the app highly. The secondary hypotheses are that symptoms of depression and anxiety will decrease with use of the MAYA app.
详细描述
There is a growing need for accessible, affordable, research-supported treatments designed for older adults. Older adults face challenges that limit their ability to physically access mental health services; thus, mobile app-based interventions may be particularly appealing to individuals in this age range with anxiety or depression who are unable to access more traditional psychotherapy administered in person by a therapist. Mobile technology has been used previously to deliver mental health services for adults with a variety of psychiatric symptoms (Dennis & O'Toole, 2014).
Anxiety frequently co-occurs with depression, with 72% of individuals with anxiety having experienced a history of depression (Moffitt et al., 2007). Current models conceptualize anxiety and depression as a confluence of three broad symptom categories - physiological hyperarousal, low positive affect, and high negative affect (Clark & Watson, 1991) - that are present to different degrees in different individuals.
This study aims to assess the acceptability, feasibility and efficacy of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in middle aged and older adults. This study will collect pilot data over the course of 12 weeks. As this is a pilot study, all participants will use the same version of the app and there will be no control group. Participants will be asked to use the mobile app for at least two days a week, for at least 20 minutes on each day, for 6 weeks. Participants will have weekly check-ins in person or via a HIPAA-compliant virtual meeting platform (e.g., Zoom) to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms at baseline, week 3, week 6 (end of treatment), and week 12 (follow up). Participants can complete optional recordings of electrical brain activity (electroencephalography, or EEG) at baseline and week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
All participants will receive the same intervention. Therefore, no masking is required.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 or older
- •Primary diagnosis of an anxiety or depressive disorder as determined by a clinical severity rating score of 4 or greater on the Anxiety Disorders Interview Schedule (ADIS).
- •Mini Mental Status Exam (MMSE) no more than 1 SD below the mean score for patient's age and education. If the remote version of the MMSE is used (e.g. during an evaluation on Zoom), the remote MMSE score will be converted to a standard MMSE score.
- •Access to an Apple iPhone, iPad, or Android device.
排除标准
- •Lifetime diagnosis of a bipolar or psychotic disorder.
- •Currently in cognitive behavior therapy.
- •Change in dose of a psychiatric medication in the past 12 weeks.
- •Initiation of psychotherapy in the past 12 weeks.
- •Intent or plan to attempt suicide.
研究组 & 干预措施
MAYA Mobile App
Participants receive treatment with the MAYA application for 6 weeks
干预措施: MAYA Mobile Application (Behavioral)
结局指标
主要结局
Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
时间窗: Week 6 (Endpoint)
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Acceptability of the MAYA application as measured by mean uMARS scores at Baseline
时间窗: Week 1 (Baseline)
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint
时间窗: Week 3 (Midpoint)
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint
时间窗: Week 6 (Endpoint)
Total number of sessions completed by the end of the administered intervention
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up
时间窗: Week 12 (Follow Up)
Total number of sessions completed by the end of the administered intervention
次要结局
- Change in depressive symptoms as measured by the MADRS(Baseline, Week 6 (Endpoint), and Week 12 (Follow Up))
- Change in anxiety symptoms as measured by the HAM-A(Baseline, Week 6 (Endpoint), and Week 12 (Follow Up))