Physiology of Liberation

NCT07780266 | Not Yet Recruiting

• 1 other identifier: 8405E
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychophysiological Reactivity and Recovery

Keywords

ecological momentary assessment; mindfulness; psychophysiology; autonomic recovery; wearable sensors; ambulatory monitoring

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Repeatedly during each enrollment period of up to 12 weeks

Secondary Outcomes (3)

• 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

Other Outcomes (4)

• Change in Systolic Blood Pressure From Pre-Event Reading

  Repeatedly during each enrollment period of up to 12 weeks

• Change in Heart Rate From Pre-Event Baseline

  Repeatedly during each enrollment period of up to 12 weeks

• Change in Respiration Rate From Pre-Event Baseline

  Repeatedly during each enrollment period of up to 12 weeks

Study Arms (3)

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.

Behavioral: Brief Standardized Mindfulness/Attention Instruction

Fixed Schedule - No Instruction

NO INTERVENTION

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

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.

Behavioral: Brief Standardized Mindfulness/Attention Instruction

Interventions

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.

Also known as: Brief mindfulness instruction, Brief attention instruction

Fixed Schedule - Instruction Throughout; Within-Person Randomized Instruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University Questrom School of Business

Boston, Massachusetts, 02215, United States

Location

Study Officials

• Jiayin Sun, PhD

  Questrom School of Business Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayin Sun, PhD

CONTACT

617-353-9640; monic@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)