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临床试验/NCT05932810
NCT05932810已完成不适用

Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Dahne

Associate Professor

Medical University of South Carolina

研究点 (2)

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