Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 747
- 试验地点
- 1
- 主要终点
- Patient Health-Questionnaire-8
研究概览
简要总结
Co-occurring symptoms of insomnia and depression is very common in breast cancer survivors, and it is critical that scalable and easily accessible digital behavioral interventions are made available. Digital health interventions are scalable and accessible. Moreover, behavioral digital interventions have been shown to be effective in reducing symptoms of insomnia and depression, respectively, in breast cancer survivors, suggesting strong potential for public impact, though their potential for addressing co-occurring symptoms of insomnia/depression has not been tested. The purpose of this study is to evaluate the efficacy of a digital insomnia program and a digital mental health program in multiple ways: 1) as standalone interventions to reduce both symptoms of co-occurring insomnia and depression for breast cancer survivors; and 2) as components in adaptive behavioral treatment strategies that optimally sequence them for survivors who need additional support, resulting in a multifaceted supportive approach that is low cost, easily accessible, and highly efficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
To enhance rigor, the PI will remain blind to participants' conditions. Given the nature of the interventions being tested, participants cannot be blinded to their condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) age ≥18 years
- •(2) Diagnosed with stage 0-3 breast cancer
- •(3) Primary treatment for cancer (i.e., chemotherapy, immunotherapy, radiation, and surgical procedures intended to remove malignant tissue) finished between 3 months to 5 years from enrollment, with the exception of adjuvant hormonal, endocrine, and immunotherapy
- •(4) elevated insomnia severity as measured by the Insomnia Severity Index (ISI) score ≥ 10, and elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10
- •(5) meets DSM 5 criteria for insomnia and depression.
排除标准
- •(1) Current behavioral or psychological treatment for insomnia or depression
- •(2) a change in medication for insomnia or depression within the past 4 weeks
- •(3) irregular sleep schedules or shift work (i.e., usual bedtimes outside 8:00 p.m.-2:00 a.m. or arising time outside 4:00 a.m.-10:00 a.m.)
- •(4) mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care (as indicated from the Pitt-Optimum Suicide Management Protocol)
- •(5) other self-reported untreated sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome)
- •(6) no reliable internet access (e.g., home broadband, public network, personal data plan) by smartphone
- •(7) cannot read and speak English
- •(8) does not reside within the US.
研究组 & 干预措施
Digital Insomnia Program First
Participants assigned to receive the digital insomnia program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital mental health program) or not.
干预措施: Digital Insomnia Program (Behavioral)
Digital Insomnia Program First
Participants assigned to receive the digital insomnia program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital mental health program) or not.
干预措施: Digital Mental Health Program (Behavioral)
Digital Mental Health Program First
Participants assigned to receive the digital mental health program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital insomnia program) or not.
干预措施: Digital Insomnia Program (Behavioral)
Digital Mental Health Program First
Participants assigned to receive the digital mental health program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital insomnia program) or not.
干预措施: Digital Mental Health Program (Behavioral)
Psychoeducation Only
Participants assigned to this arm will only receive the psychoeducation program for 9 weeks. They will not be eligible to be re-randomized to receive additional program.
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Patient Health-Questionnaire-8
时间窗: Baseline
Patient Health Questionnaire-8
时间窗: Post 18-weeks
Insomnia Severity Index
时间窗: Baseline
Insomnia Severity Index
时间窗: Post 18-weeks
Patient Health-Questionnaire-8 (PHQ-8)
时间窗: Baseline
8 item measure to evaluate severity of depression symptoms. Each item is evaluated on a scale from 0-3. Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.
Patient Health Questionnaire-8 (PHQ-8)
时间窗: Post 18-weeks
8 item measure to evaluate severity of depression symptoms. Each item is evaluated on a scale from 0-3. Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.
Insomnia Severity Index (ISI)
时间窗: Baseline
7 item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
Insomnia Severity Index (ISI)
时间窗: Post 18-weeks
7 item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
次要结局
未报告次要终点
研究者
Philip Chow, Ph.D.
Associate Professor
University of Virginia