Physiology of Liberation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University Charles River Campus

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Brief Standardized Mindfulness/Attention Instruction

    Behavioral

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Fixed Schedule - Instruction ThroughoutExperimental treatment 1 intervention
Group B: Fixed Schedule - No InstructionNo intervention 0 interventions
Group C: Within-Person Randomized InstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

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
2

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
3

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
4

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

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