A Pre-post Pilot of a Smartphone Intervention
A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones
Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills.
Digital health interventions delivered through smartphones have strong potential to improve access to care for the large number of breast cancer survivors who need mental and behavioral health support. There is a need to evaluate a range of supportive interventions that target different aspects of mental health, including negative thinking, coping skills, and knowledge. Our research team has previously tested individual digital interventions in relatively small samples, and found that they were effective in reducing mood symptoms among women with breast cancer.
The ultimate goal of this project is to evaluate how integrating these interventions into a single 8-week long app program affects mood and overall mental health in breast cancer survivors. The digital micro-interventions to be tested in this study are brief interventions that target specific behavioral and cognitive mechanisms of mental health. These include skills such as reducing negative thinking patterns, increasing knowledge of mental health factors, fostering a grateful outlook, promoting the practice of relaxation breathing, savoring positive memories, and acceptance-based mindfulness approaches.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Philip Chow, PhD
- 电话号码:434-924-8082
- 邮箱:pic2u@virginia.edu
学习地点
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Virginia
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Charlottesville、Virginia、美国、22904
- University of Virginia
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- age = 18 years
- 0-5 years post-diagnosis of Stage I, II, or III female breast cancer
- elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score > 9) or GAD-7 (score > 7).
Exclusion Criteria:
- receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)
- active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources
- do not have an app-compatible phone
- cannot read and speak English (intervention and measures only available in English).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Digital Intervention
Participants are provided with a suite of digital micro-interventions over an 8 week period
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数字微型干预是针对精神健康的特定行为和认知机制的简短干预措施,旨在短暂参与。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety Symptoms
大体时间:Baseline
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7 item scale that measures anxiety symptoms on a continuous scale.
Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
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Baseline
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Anxiety Symptoms
大体时间:Post 8-week Intervention
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7 item scale that measures anxiety symptoms on a continuous scale.
Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
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Post 8-week Intervention
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Depression symptoms
大体时间:Baseline
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8 item scale that measures depression symptoms on a continuous scale.
Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
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Baseline
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Depression symptoms
大体时间:Post 8-week Intervention
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8 item scale that measures depression symptoms on a continuous scale.
Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
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Post 8-week Intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.