A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Feasibility as assessed by listening rate
研究概览
简要总结
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.
详细描述
Mindfulness-based interventions (MBIs), including Mindfulness-based Cognitive Therapy (MBCT), reduce depressive symptoms in medically ill populations, including cancer survivors. However, MBIs have limitations, and if improved, could dramatically increase their clinical reach and impact. Most standardized MBIs are group-based, time intensive, difficult to scale, and can be costly. Thus, only a small portion of patients ever engage with MBIs. Digital approaches to delivering mindfulness content (apps and brief MBIs) have shown promise for addressing these barriers to accessibility and scalability. However, these digital approaches are not typically tailored for people with medical illness, like cancer, and/or have poor adherence. Mindfulness app user engagement decreases by 90% within 7 days of download, and the average total use of the app is only 16-21 minutes. Moreover, a recent review of MBIs that included standardized group-based MBIs (e.g., Mindfulness-Based Stress Reduction [MBSR]) and three mindfulness-based apps (e.g., Calm) estimated a 40-60% adherence rate of assigned at-home practice (30-45 minutes/day) in cancer survivors during the MBI, which further declines post-intervention. This suggests that the currently prescribed daily practice dosages are not feasible or accepted by this population. Thus, a brief MBI that optimizes the accessibility and scalability and other benefits of digital and asynchronous delivery, in a feasible and acceptable format, is critically needed for people with depressive symptoms and medical illness.
MBCT, adapted into a brief, daily and digitally delivered format, could increase access, scalability, acceptability, and adherence. While consistent practice for longer sessions yields the most benefit,21 studies have shown improved mood following 5 and 13 minutes of daily meditation for 2 and 8 weeks, respectively. Further, because creating and sustaining a new behavior, like daily meditation, requires consistent repetition, it is plausible that delivering content in short, digestible segments each day, as opposed to longer, weekly sessions, could improve adherence and sustain engagement. The full-length, 8-week MBCT protocol delivered digitally reduces depressive symptoms in cancer survivors, and the standardized 8-week MBCT protocol has already been abbreviated from 2- to 1-hour weekly groups (MBCT-Brief). When tested via remote delivery (telephone), MBCT-Brief showed a decrease in depressive symptoms in participants with medical illness (i.e., hypertension). Because of its abbreviated format and evidence for reducing depressive symptoms in people with medical illness, MBCT-Brief is a logical and feasible intervention to adapt into a daily text-delivered format for depressive symptoms in post-treatment cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9).
- •A diagnosis of stage 0-III breast, prostate, or colorectal cancer.
- •Completion of primary cancer treatment within 2 years (excludes hormone therapy).
- •An ability to provide informed consent.
- •An ability to read and speak English.
- •Access to a web-enabled device (phone, tablet, computer).
排除标准
- •Self-reported minimal and severe depressive symptoms (<4 and > 20 on PHQ-9).
- •Self-reported suicidal ideation (>1 on item 9 PHQ-9).
- •Another psychological, medical, or other condition/issue determined that necessitates priority treatment and/or that would interfere with participation (e.g., schizophrenia, borderline personality disorder)
- •Current or recent substance abuse/dependence.
- •Stage IV cancer diagnosis.
- •A cancer recurrence actively requiring treatment.
- •Self-reported active mindfulness practice.
- •Prior participation in a formal mindfulness program (e.g., MBCT, Mindfulness-Based Stress Reduction Program, Mindfulness-Based Cancer Recovery
研究组 & 干预措施
ARM 1
Participants will be randomized to MINDSET
干预措施: MINDSET (Behavioral)
ARM 2
Participants will be randomized to EUC
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Feasibility as assessed by listening rate
时间窗: 12 weeks
80% listening rate of daily audio content
Feasibility as assessed by sample retention rate
时间窗: 12 weeks
80% sample retention
Acceptability rate as assessed by satisfaction rating of daily audio content
时间窗: 12 weeks
(\>8 median satisfaction rating of daily audio content is measured as accepatble
Acceptability rate as assessed by Client Satisfaction Questionnaire (CSQ-8) post-MINDSET
时间窗: 12 weeks
\>24 on the Client Satisfaction Questionnaire (CSQ-8) post-MINDSET will be considered as acceptable. CSQ-8 is a list of questions rating the satisfaction ranging from quite dissatisfied to very satisfied
次要结局
- Symptoms of depression as measured by PROMIS-D-SF(12 weeks)
- Symptoms of anxiety as measured by PROMIS-A-SF(12 weeks)
