An interventional study of Brief Standardized Mindfulness/Attention Instruction in Psychophysiological Reactivity and Recovery, sponsored by Boston University Charles River Campus. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Basic science
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.
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. Prior meditation or contemplative practice is recorded at baseline and treated as a covariate in analysis; it is not used for assignment and does not define a study arm. Active data collection lasts up to 12 weeks. Equipment return and the wrap-up contact follow within two weeks after data collection ends. 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.
Boston University Charles River Campus is the lead sponsor of 159 studies on the registry; 33 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 5, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Brief Standardized Mindfulness/Attention Instruction
No attention instruction at any point during the enrollment period. Surveys, devices and schedule are identical to the other schedules.
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.
Behavioral: Brief 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.
Also known as: Brief mindfulness instruction, Brief attention instruction
Time to 50% Return to Pre-Event Baseline Skin Conductance Level
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.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Percentage of High-Urge Events Not Followed by a Reactive Action
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 frame: Repeatedly during each enrollment period of up to 12 weeks
Change in Skin Conductance Level From Pre-Event Baseline
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.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Percentage of EMA Events With Complete Time-Aligned Physiological Data
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.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Within-Person Coupling Between Sympathetic Arousal and Self-Referential Appraisal
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.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Change in Systolic Blood Pressure From Pre-Event Reading
Within-person change in systolic blood pressure from the participant-specific pre-event reading to the first post-event reading, obtained by ambulatory or home upper-arm blood-pressure monitor during prespecified measurement windows. Readings flagged by the device as invalid, or taken outside a defined event window, are excluded. The value reported is the participant-level median change across all qualifying event pairs, in millimeters of mercury.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Change in Heart Rate From Pre-Event Baseline
Within-person change in heart rate from the participant-specific pre-event baseline window to the peak value observed in the post-event observation window, derived from the chest-strap electrocardiogram recording. 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 beats per minute.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Change in Respiration Rate From Pre-Event Baseline
Within-person change in respiration rate from the participant-specific pre-event baseline window to the peak value observed in the post-event observation window, derived from the chest-worn respiration belt. 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 breaths per minute.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Time to 50% Return to Pre-Event Baseline Heart Rate Variability (RMSSD)
Within-person cardiac autonomic recovery speed following an ecological momentary assessment (EMA)-reported everyday trigger, in the subset of participants assigned the chest-strap electrocardiogram device. For each qualifying event, RMSSD (root mean square of successive RR interval differences) is computed in rolling windows. Recovery half-life is the elapsed time from the post-event RMSSD nadir until RMSSD returns to 50% of the difference between that nadir 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.
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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