Psychophysiological Reactivity and RecoveryNCT07780266
Physiology of Liberation
A study testing Brief Standardized Mindfulness/Attention Instruction in people with Psychophysiological Reactivity and Recovery, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychophysiological Reactivity and Recovery
- What is being tested?
- Brief Standardized Mindfulness/Attention Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cannabis or other illicit drug use within the past 30 days, or intended use during the study period
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston University Questrom School of Business
Boston, Massachusetts, 02215
Jiayin Sun, PhD, 617-353-9640, monic@bu.edu
About this study
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.
Read the 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. 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.
- Being tested
- Brief Standardized Mindfulness/Attention Instruction
- Keywords
- ecological momentary assessment, mindfulness, psychophysiology, autonomic recovery, wearable sensors, ambulatory monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Standardized Mindfulness/Attention InstructionBehavioural
Also called Brief mindfulness instruction, Brief 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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Schedule - Instruction Throughout | Experimental | 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. Receives: Behavioral: Brief Standardized Mindfulness/Attention Instruction |
| Fixed Schedule - No Instruction | No intervention | No attention instruction at any point during the enrollment period. Surveys, devices and schedule are identical to the other schedules. |
| Within-Person Randomized Instruction | Experimental | 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. Receives: Behavioral: Brief Standardized Mindfulness/Attention Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Repeatedly during each enrollment period of up to 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Repeatedly during each enrollment period of up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychophysiological Reactivity and RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiayin Sun, PhD, Principal investigator, Questrom School of Business Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780266
- Sponsor's protocol ID
- 8405E
- Status last verified
- Nov 2026
- First submitted
- 13 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Liberation
- ClinicalTrials.gov ID
- NCT07780266
- Acronym / sponsor ID
- 8405E
- Keywords
- ecological momentary assessment, mindfulness, psychophysiology, autonomic recovery, wearable sensors, ambulatory monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fixed Schedule - Instruction Throughout | Experimental | Behavioral: Brief Standardized Mindfulness/Attention InstructionParticipants 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. |
| Fixed Schedule - No Instruction | No intervention | –No attention instruction at any point during the enrollment period. Surveys, devices and schedule are identical to the other schedules. |
| Within-Person Randomized Instruction | Experimental | Behavioral: Brief Standardized Mindfulness/Attention InstructionBrief 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cannabis or other illicit drug use within the past 30 days, or intended use during the study period
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Standardized Mindfulness/Attention InstructionAlso: Brief mindfulness instruction, Brief attention instructionAt 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. | Behavioural | Fixed Schedule - Instruction Throughout, Within-Person Randomized Instruction |
Primary outcome
Time to 50% Return to Pre-Event Baseline Skin Conductance Level
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Skin Conductance Level From Pre-Event Baseline
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Percentage of EMA Events With Complete Time-Aligned Physiological Data
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Within-Person Coupling Between Sympathetic Arousal and Self-Referential Appraisal
Time frame: Repeatedly during each enrollment period of up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiayin Sun, PhD principal investigator
Questrom School of Business Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Standardized Mindfulness/Attention Instruction in people with Psychophysiological Reactivity and Recovery, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayin Sun, PhD (617-353-9640, monic@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to 50% Return to Pre-Event Baseline Skin Conductance Level (time frame: Repeatedly during each enrollment period of up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.