Psychophysiological Reactivity and Recovery
Conditions
Keywords
ecological momentary assessment, mindfulness, psychophysiology, autonomic recovery, wearable sensors, ambulatory monitoring
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBrief Standardized Mindfulness/Attention Instruction
At one or more assigned study measurement sessions, participants receive a brief, standardized, non-clinical instruction lasting approximately 1 to 10 minutes. The instruction directs attention to breathing or another clear body sensation, briefly acknowledges thoughts, emotions, wanting, resisting, or urges, and returns attention to the selected sensation. The number, duration, and schedule of sessions are specified before each study wave begins and applied consistently within that wave; comparison sessions are time-matched. Participants may open their eyes, change position, or stop at any time.
Sponsors
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomized at enrollment to one of three assignment schedules. In the primary schedule, brief attention instructions are randomized within participant at the level of the day-block, so each participant contributes both instructed and non-instructed observation periods, balanced across days of the week. In the two fixed-condition schedules, participants receive either the attention instruction at every eligible prompt, or no attention instruction, for the full enrollment period. The fixed-condition schedules provide a between-person comparison and allow the magnitude of carryover between periods to be estimated directly. Allocation is unequal, weighted toward the within-person schedule.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 50% Return to Pre-Event Baseline Skin Conductance Level | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Conductance Level From Pre-Event Baseline | Repeatedly during each enrollment period of up to 12 weeks | Within-person change in tonic skin conductance level from the participant-specific pre-event baseline window to the peak value observed in the post-event observation window, derived from the wrist-worn electrodermal activity sensor. Events without a usable pre-event baseline window or with excessive motion artifact are excluded. The value reported is the participant-level median change across all qualifying events, in microsiemens. |
| Percentage of EMA Events With Complete Time-Aligned Physiological Data | Repeatedly during each enrollment period of up to 12 weeks | Feasibility of the time-aligned multimodal ambulatory assessment protocol. For each ecological momentary assessment (EMA) reported event, an event window is considered successfully aligned when the EMA timestamp can be matched to at least one continuously recorded physiological stream with usable signal quality across the full pre-event baseline window and post-event observation window. The value reported is, for each participant, the number of successfully aligned events divided by the total number of EMA-reported events, expressed as a percentage. |
| Within-Person Coupling Between Sympathetic Arousal and Self-Referential Appraisal | Repeatedly during each enrollment period of up to 12 weeks | Within each participant, momentary self-referential appraisal ratings are regressed on the amplitude of the time-aligned electrodermal response, expressed relative to that participant's same-day calibration range. The reported value is the participant-level regression slope, in appraisal rating points per standardized electrodermal unit. The effect of the attention instruction is estimated as the change in this slope between instructed and non-instructed observation periods. |
Countries
United States
Contacts
CONTACTJiayin Sun, PhD
PRINCIPAL_INVESTIGATORJiayin Sun, PhD
Questrom School of Business Boston University
Outcome results
None listed