Physiology of Liberation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Time to 50% Return to Pre-Event Baseline Skin Conductance Level
研究概览
简要总结
This academic study examines how everyday experiences are related to short-term physiological reactivity and recovery and whether one or more brief standardized mindfulness/attention-instruction sessions change these patterns. Adults living in the United States who can read and understand the English study materials participate for up to 12 weeks and complete brief smartphone surveys several times a day during waking hours. Surveys include current experiences and recent alcohol and nicotine use; these reports are analyzed as contextual variables and are not automatic exclusion criteria. Some participants also use assigned non-invasive wearable sensors or blood-pressure monitors during prespecified measurement windows. Device output is used only for research measurement, not diagnosis, treatment, real-time medical decision-making, or patient management. In study waves with a randomized comparison, participants are randomized after consent to one or more brief mindfulness/attention-instruction sessions or time-matched no-instruction comparison sessions. Session duration, schedule, and allocation probabilities are specified before each study wave begins and applied consistently within that wave.
详细描述
After informed consent and eligibility screening, participants complete baseline questions about health, medication use, daily habits (including typical alcohol and nicotine use), well-being, and prior mindfulness or meditation experience. Participants then complete smartphone ecological momentary assessment (EMA) surveys about current context, appraisals, action tendencies, downstream cost, stress or activation, perceived recovery, and recent alcohol and nicotine use since the prior prompt (or since waking for the first daily prompt). EMA is delivered several times a day during waking hours within an enrollment period of up to 12 weeks. Alcohol and nicotine reports are collected after consent and may be analyzed as time-varying contextual variables or covariates in relation to EMA and physiological response and recovery; they also document whether scheduled measurements occurred within requested abstinence windows.
Throughout this record, an "event" refers to a participant-reported everyday trigger: an ordinary moment the participant identifies as having provoked a reaction, such as an interpersonal exchange, a work demand, an intrusive thought, or an environmental cue. Events are reported by the participant at the time they occur. Events are distinct from the brief attention-instruction sessions, which are delivered according to the randomization schedule rather than reported by the participant.
Depending on the active measurement wave, participants may be assigned non-invasive devices measuring heart rate, blood pressure, breathing, movement, sleep, skin signals, electroencephalography, or exploratory functional near-infrared spectroscopy signals. Device assignment follows the measurement plan, device availability and fit, and safety screening; not every participant receives every device. Device-specific safety restrictions may limit assignment to a particular device without excluding participation in other procedures.
In study waves with the randomized component, a computer-generated schedule assigns participants after consent to the mindfulness/attention-instruction condition or the no-instruction comparison. Allocation probabilities are specified before each study wave begins and are not determined by participant characteristics, study outcomes, or interim outcome analyses. Participants may receive one or more brief standardized mindfulness/attention-instruction sessions or time-matched no-instruction comparison sessions. Each session lasts approximately 1 to 10 minutes; the number, duration, and schedule of sessions are specified before each study wave begins and applied consistently within that wave. This randomized assignment is separate from observational comparisons based on prior mindfulness or meditation experience. A single enrollment does not exceed six months, including administrative follow-up. Participants may be invited to take part in future study periods under the same approved procedures, each requiring new consent and screening; a participant who takes part in more than one study period is counted only once toward the cap of 100 unique participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and study staff are aware of assignment. Primary analyses are conducted with condition labels randomly permuted; the analysis pipeline is finalized and executed on permuted data, and results are generated only after the pipeline is locked and labels are restored.
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
- •Adults aged 18 years or older
- •Lives in the United States
- •Able to read and understand English well enough to provide informed consent and to complete study surveys and instructions
- •Has a compatible smartphone and the required study application
- •Willing to complete ecological momentary assessment (EMA) and assigned study procedures
排除标准
- •Cannabis or other illicit drug use within the past 30 days
- •Any current pattern of substance use that would prevent informed consent or the safe and reliable completion of study procedures
- •Inability or unwillingness to complete core study procedures
- •Lack of a compatible smartphone or the required study application
研究组 & 干预措施
Fixed Schedule - Instruction Throughout
Participants receive one or more brief standardized mindfulness/attention-instruction sessions at assigned measurement sessions and complete the same measurement schedule as the comparison arm. Each session lasts approximately 1 to 10 minutes. The number, duration, and schedule of sessions are specified before each study wave begins and applied consistently within that wave.
干预措施: Brief Standardized Mindfulness/Attention Instruction (Behavioral)
Fixed Schedule - No Instruction
Participants sit quietly in a comfortable position as they normally would during one or more time-matched no-instruction comparison sessions. No particular attention or meditation method is requested. Each session lasts approximately 1 to 10 minutes. The number, duration, and schedule of sessions are specified before each study wave begins and applied consistently within that wave; participants complete the same measurement schedule as the experimental arm.
Within-Person Randomized Instruction
Brief standardized mindfulness/attention instructions are delivered on randomly assigned day-blocks and withheld on the remaining day-blocks, with the sequence randomized within each participant and balanced across days of the week. All ecological momentary assessment and ambulatory physiological monitoring procedures are identical on instructed and non-instructed day-blocks. Each instruction session lasts approximately 1 to 10 minutes. Participation in any individual instruction is voluntary; whether the participant performed it is recorded.
干预措施: Brief Standardized Mindfulness/Attention Instruction (Behavioral)
结局指标
主要结局
Time to 50% Return to Pre-Event Baseline Skin Conductance Level
时间窗: Repeatedly during 14 EMA days within each enrollment period of up to 4 weeks
Within-person physiological recovery speed following an ecological momentary assessment (EMA)-reported everyday trigger, measured with the wrist-worn electrodermal activity sensor that all enrolled participants receive. For each qualifying event, tonic skin conductance level is computed in rolling windows. Recovery half-life is the elapsed time from the post-event peak until skin conductance returns to 50% of the difference between that peak and the participant-specific pre-event baseline. Events without a usable pre-event baseline window or with excessive motion artifact are excluded. The value reported is the participant-level median across all qualifying events, in minutes.
Percentage of High-Urge Events Not Followed by a Reactive Action
时间窗: Repeatedly during 14 EMA days within each enrollment period of up to 4 weeks
Within-person urge-action decoupling. At each ecological momentary assessment (EMA) prompt, participants rate urge intensity on a 0 to 10 scale and report whether a reactive action occurred. A high-urge event is defined as an EMA report with urge intensity at or above a threshold prespecified before analysis. Decoupling is scored when a high-urge event is reported without an accompanying reactive action. The value reported is, for each participant, the number of high-urge events without a reactive action divided by the total number of high-urge events, expressed as a percentage.
Time to 50% Return to Pre-Event Baseline Skin Conductance Level
时间窗: Repeatedly during each enrollment period of up to 12 weeks
Within-person physiological recovery speed following an ecological momentary assessment (EMA)-reported everyday trigger, measured with the wrist-worn electrodermal activity sensor that all enrolled participants receive. For each qualifying event, tonic skin conductance level is computed in rolling windows. Recovery half-life is the elapsed time from the post-event peak until skin conductance returns to 50% of the difference between that peak and the participant-specific pre-event baseline. Events without a usable pre-event baseline window or with excessive motion artifact are excluded. The value reported is the participant-level median across all qualifying events, in minutes.
Percentage of High-Urge Events Not Followed by a Reactive Action
时间窗: Repeatedly during each enrollment period of up to 12 weeks
Within-person urge-action decoupling. At each ecological momentary assessment (EMA) prompt, participants rate urge intensity on a 0 to 10 scale and report whether a reactive action occurred. A high-urge event is defined as an EMA report with urge intensity at or above a threshold prespecified before analysis. Decoupling is scored when a high-urge event is reported without an accompanying reactive action. The value reported is, for each participant, the number of high-urge events without a reactive action divided by the total number of high-urge events, expressed as a percentage.
次要结局
- Change in Skin Conductance Level From Pre-Event Baseline(Repeatedly during 14 EMA days within each enrollment period of up to 4 weeks)
- Percentage of EMA Events With Complete Time-Aligned Physiological Data(Repeatedly during 14 EMA days within each enrollment period of up to 4 weeks)
- Change in Skin Conductance Level From Pre-Event Baseline(Repeatedly during each enrollment period of up to 12 weeks)
- Percentage of EMA Events With Complete Time-Aligned Physiological Data(Repeatedly during each enrollment period of up to 12 weeks)
- Within-Person Coupling Between Sympathetic Arousal and Self-Referential Appraisal(Repeatedly during each enrollment period of up to 12 weeks)
研究者
Jiayin Sun
Principal Investigator
Boston University Charles River Campus