Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accrual
研究概览
简要总结
The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by the investigators to assist with the treatment of depressed mood.
Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not.
All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as the participant's experiences using Moodivate and participating in this trial. Participation in this study will take about 4 weeks, beginning today.
Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include the participant contacting their primary care provider or their oncology care team to discuss other available treatments for depressed mood.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elevated depressive symptoms, defined as a score of ≥ 10 on the PHQ-936
- •ILLIC (as determined during manual chart review)
- •currently own an iOS- or Android-compatible smartphone
- •report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
- •have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)
- •English fluency
排除标准
- •Severe cognitive impairment that precludes completion of informed consent
- •current suicidal ideation on the PHQ-9 at screening or final study eligibility, defined as a response ≥1 (several days) on item nine
研究组 & 干预措施
Moodivate
Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
干预措施: Behavioral Activation Therapy app (Behavioral)
Treatment as Usual
Participants in the treatment as usual group will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their oncology provider. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
干预措施: Treatment as Usual (Behavioral)
结局指标
主要结局
Accrual
时间窗: Study duration (6-7 months or until recruitment is reached)
The proportion of Illic eligible for the trial who accrue to the study.
次要结局
未报告次要终点
研究者
Jennifer Dahne
Associate Professor
Medical University of South Carolina