Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.
研究概览
简要总结
The purpose of this study is to determine if an N-of-1 study design, or within-subject trials that the investigators are calling "Personalized Trials" can improve health outcomes over standard practice for common stress management techniques. This study uses three different stress management interventions to improve individual self-report of perceived stress: guided mindfulness meditation, guided yoga, and guided brisk walking. Arm 1 (n=53) and Arm 2 (n=53) of the trial will deliver the interventions using a Personalized Trial (within-subject, single N, cross-over trial) format. Participants in Arm 3 of the trial (N=106) will be offered the same number of interventions but will not be required to follow the established N-of-1 Personalized Trials framework. At the end of their Personalized Trial, participants in Arms 1 and 2 will receive a summarized report with personalized feedback. Participants in Arm 3 will also receive a report, but with summarized data . Both arms will receive 2 additional weeks of the stress management intervention of their choosing, while continuing to answer daily assessments and wear a Fitbit device. At the end of the study, a final survey will be sent assessing satisfaction with the study.
详细描述
The purpose of this study is to determine if an N-of-1 (within-subject, single N, cross-over trial) study design, or what the investigators are calling "Personalized Trials" can improve health outcomes over standard practice for common stress management techniques, and can have widespread use in future research and clinical practice to address high public health burdens with a high heterogeneity of treatment response. This study is informed by three previously conducted feasibility pilots of methods to remotely implement Personalized Trials. This current study uses three different stress management interventions to improve individual self-report of perceived stress: guided mindfulness meditation, guided yoga, and guided brisk walking. Participants randomized to Arm 1 (N=53) and Arm 2 (N=53) will receive Personalized Trials stress management interventions (with arms receiving different order of interventions), whereas participants randomized to Arm 3 (N=106) will receive interventions but will not be required to follow the Personalized Trials format. All participants will begin with a 2-week run-in period, where no stress management interventions are given, but data are collected, including daily surveys and Fitbit-derived sleep and activity data, to obtain a baseline average for later statistical comparison. After successful completion of the baseline period, participants will be randomized to receive either one of two orders of 12-weeks of a Personalized Trial or self-directed (standard care) experience, where they can test 3 different stress management techniques in any order they choose while continuing to answer daily assessments and wearing their Fitbit device. At the end of the 12 weeks, all participants will continue to answer daily surveys and wear their Fitbit device for 2 weeks with no experimenter provided intervention, while the study team creates a report containing the individual's observed data. This report will be sent to each participant in all arms, and participants will have the opportunity to select one stress management technique to continue with for 2 additional weeks. After selection, participants will receive six additional sessions of their chosen treatment and will be observed for engagement in these additional wellness sessions. Participants will also be asked to complete daily survey assessments and Fitbit wear for these two additional weeks. At the end of the 18-week study, a final survey will be sent assessing satisfaction with the study. A random sample of 10% of participants from each arm will be asked to participate in a qualitative interview to discuss their experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Age ≥ 18 years
- •English speaking
- •Self-report of perceived stress raw score of 20 or higher using the Perceived Stress Scale (PSS)
- •Owns and can regularly access a smartphone capable of receiving text messages and accessing the internet
- •Can regularly wear a Fitbit device
- •Lives in the United States
排除标准
- •Age < 18 years old
- •Women who are pregnant
- •Does not speak English
- •Does not own or cannot regularly access a smartphone capable of receiving text messages
- •Cannot regularly wear a Fitbit device
- •Deemed unable to complete the study protocol as a result of cognitive impairment, severe medical or mental illness, or active or prior substance abuse
- •Planned surgeries 6 months from study start date
- •Individuals who have been previously told by a doctor to not engage in brisk walking 30 minutes, three times per week
- •Individuals who have been previously told by a doctor to not engage in yoga
- •Lives outside the United States
研究组 & 干预措施
Personalized Trial ABCCBA
Participants in Arm 1 will receive a Personalized Trial of the 3 stress management interventions in an ABCCBA treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of study-provided stress management content each week.
干预措施: Personalized Trial ABCCBA (Behavioral)
Personalized Trial CBAABC
Participants in Arm 2 will receive a Personalized Trial of the 3 stress management interventions in a CBAABC treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of the study-provided stress management content each week.
干预措施: Personalized Trial CBAABC (Behavioral)
Standard Care
Participants in Arm 3 will receive Standard Care of the 3 stress management techniques (mindfulness meditation, yoga, and brisk walking). Participants will receive access to the same number of views of the mindfulness meditation, yoga, and brisk walking content given to participants randomized in Arm 1 and Arm 2. However, they will not be prompted to complete any session according to a randomization sequence. A link to the stress management video will be delivered via text 1 time per week to the participant. Participants will be limited to 36 total views of study-provided stress management content (12 total views per stress management technique).
干预措施: Stress Management Techniques with No Randomization Sequence (or order) (Behavioral)
结局指标
主要结局
Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.
时间窗: EMA stress will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) during follow-up period (13-18 weeks).
Stress will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their stress on a scale of 0 (low) to 10 (high). Levels of EMA stress will be aggregated within the baseline assessment period and during the follow-up period to generate an overall mean and standard deviation for each period. The change in EMA stress between baseline and follow-up will be calculated by subtracting these aggregated means. The difference in change in EMA stress between baseline and follow-up periods will be compared between the personalized arms (Arm 1 and 2) and the standard of care arm (Arm 3) using a two-sample t-test and Generalized Linear Mixed Model analyses.
次要结局
- Agreement of Intervention Selection Between Participant and Researcher.(Assessed after completion of follow-up (18 weeks from baseline).)
- Mean System Usability Score (SUS).(Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).)
- Participant Satisfaction With Personalized Trial Components.(Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.(EMA stress will be assessed 3 times daily via text message during the 18 week trial.)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.(EMA fatigue will be assessed 3 times daily via text message during the 18 week trial.)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.(EMA pain will be assessed 3 times daily via text message during the 18 week trial.)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.(EMA mood will be assessed 3 times daily via text message during the 18 week trial.)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.(EMA concentration will be assessed 3 times daily via text message during the 18 week trial.)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.(EMA confidence will be assessed 3 times daily via text message during the 18 week trial.)
- Change in Mean Within-Subject Difference in Weekly Perceived Stress.(Perceived stress will be assessed weekly during the baseline assessment period (2 weeks) during follow-up period (13-18 weeks).)