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NCT Number: NCT07505641

Breathing and Decision-Making (ProlEx-Context)

The ProlEx-Context study aims to investigate how a slow-paced breathing technique with prolonged exhalation affects decision-making in the context of acute social stress.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The ProlEx-Context study explores how a slow breathing technique with prolonged exhalation can restore decision-making processes after exposure to acute social stress.

Method Overview:

The methods of the study include a guided breathing exercise (prolonged exhalation vs normal breathing rhythm), exposure to acute social stress, peripheral electrophysiology (respiration, pulse, gastric and cardiac rhythms, skin conductance, pupillometry), salivary cortisol sampling, psychological questionnaires, behavioral tasks and functional brain imaging with fMRI.

Participant Overview:

An estimated 50 participants will be invited to this within-subject fMRI study and will be blinded to the stress induction component of this study.

Time frame:

One appointment of approx. 4 hours per person.

Procedure Overview:

Participants will be invited to the testing site at approximately 4 PM. Upon completion of the preparations and placement inside the MRI, the participants will undergo an adapted virtual Trier Social Stress Test (TSST). After completing the TSST, the participants are asked to perform a risk decision-making task inside the MRI, during which they are displayed a visual cue to assist during guided breathing. The participants perform blocks of either normal breathing or prolonged exhalation breathing during performance of the decision-making task in a randomized cross-over-design. During the task, brain activity and peripheral physiological signals, such as the respiration rate, heart rate, skin conductance and pupil dilation are measured. After completion of the first breathing condition (three blocks) and before the second breathing condition, participants will undergo a second TSST. Before and after each TSST, at baseline and after completion of the decision-making task, salivary samples for cortisol assessment are taken. After completion of the decision-making task, participants will be asked to fill out a battery of psychometric questionnaires and reimbursed for their time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18- to 40-year-old men and women
  • Consent to participate
  • Fluent in German
  • Right-handed
  • Physically and mentally healthy without regular medication
  • Body-mass index of 18-25 kg/m2
  • Alcohol consumption of less than 15 glasses a week (equivalent to one glass of wine/beer, a glass of higher-percentage alcohol counts as two glasses of beer)
  • No illegal drug consumption in the week previous to the experiment
  • No smoking
  • No competitive athletes
  • Normal day-night rhythm (no shift work)
  • Normal vision without required vision correction (i.e., glasses, contact lenses; ability to clearly read texts at a distance of up to 50 cm without vision aids)

Exclusion criteria

  • Former or current illnesses of:
  • Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
  • Heart or blood circulation
  • Lung Diseases
  • Other serious past or present medical conditions (for example, metabolic syndrome, diabetes)
  • Current medication and medication over a period of two weeks prior to the examination
  • Other serious health problems or present strong mental or physical stress
  • Current infection or excessive stress
  • Missing consent to receive information about incidental findings from the MRI
  • Tendency to claustrophobia, dizziness, or panic attacks
  • Wearing a non-removable pacemaker, defibrillator, hearing aid, drug pump, neurostimulator or implant with solenoid valve (e.g., artificial bowel outlet)
  • Metal parts or implants inside the body, for example, due to surgery or injury with a metallic foreign object (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coil, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents)
  • Having non-removable metal parts or metal-containing devices on or in the body
  • Having ferromagnetic metal parts or implants inside the body (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coils, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents)
  • Wearing magnetically fixed implants (e.g. amalgam fillings, glass eye)
  • Professionally or privately being involved in the processing of ferromagnetic metals
  • Large tattoos (whole limbs)
  • Pregnancy
  • Wearing an intra-uterine device
  • Having tinnitus
  • Extensive lung function (e.g. apnoe diver, singer, professional musician with lung-involving instruments)
  • Previous participation in the ProlEx-MRI study (the precursor to the current study)

Treatment and study plan

Instructed Prolonged Exhalation

Behavioral

Participants are required to perform a specific instructed breathing pattern directed by visual cues. The core characteristic is a systematic lengthening of the expiratory phase relative to the inspiratory phase. Specifically, participants are instructed to inhale for 2 seconds and prolong their exhalation to 8 seconds.

Instructed Individualized Eupnea

Behavioral

Instructed Individualized Eupnea: In this control condition, participants are instructed to match their breath to a visual cue that is calibrated to their own characteristic natural respiratory frequency. This frequency is sampled during representative non-interventional phases of the session to capture the participant's individual baseline eupnea pace within the experimental context.

Primary outcomes

  1. Risk propensity

    Time frame: On day 1.

    The dependent variable will be trial-wise gamble acceptance (accept vs. reject of a 50% gamble), which will be mainly analyzed using a binomial generalized linear mixed-effects model (GLMM) to compare the Prolonged Exhalation and Eupnea conditions under acute stress.

  2. Task-related BOLD Signals

    Time frame: On day 1.

    Task-related changes in blood-oxygen-level-dependent (BOLD) signals measured using functional magnetic resonance imaging (fMRI).

  3. Structural T1-weighted MRI

    Time frame: On day 1.

    High-resolution T1-weighted structural images measured using magnetic resonance imaging (MRI).

  4. Relative amplitude of the respiratory signal

    Time frame: On day 1.

    Task-based and resting-state relative respiratory amplitude, measured via a respiratory belt and nasal airflow sensor.

  5. Respiration rate

    Time frame: On day 1.

    Task-based and resting-state relative respiratory amplitude, measured via a respiratory belt and nasal airflow sensor.

  6. Heart rate

    Time frame: On day 1.

    Task-based and resting-state heart rate, measured with ECG

  7. Heart-rate variability

    Time frame: On day 1.

    Task-based and resting-state heart-rate variability, measured with a three-point electrocardiogram (ECG)

  8. Gastric myoelectrical activity

    Time frame: On day 1.

    Resting-state and task-based gastric myoelectrical activity, measured using cutaneous electrogastrography (EGG).

  9. Tonic skin conductance

    Time frame: On day 1.

    Tonic task-based and resting-state electrodermal activity, measured with EDA electrodes

  10. Event-related skin conductance responses

    Time frame: On day 1.

    Phasic electrodermal activity, measured via electrodermal activity (EDA) electrodes

  11. Salivary Cortisol Levels

    Time frame: On day 1.

    Concentration of cortisol in saliva (measured in nmol/L). This indexes the HPA-axis response to the Trier Social Stress Test (TSST). We will compare the cortisol trajectory

  12. Pupil dilation

    Time frame: On day 1.

    Task-based and resting-state pupil dilation, measured via eye-tracking

Secondary outcomes

  1. Response Times

    Time frame: On day 1.

    The average time (in milliseconds) taken by participants to make a choice in each trial.

  2. Self-reported levels of stress

    Time frame: On day 1.

    Self-reported levels of stress will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."

  3. Self-reported levels of tension

    Time frame: On day 1.

    Self-reported levels of tension will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."

  4. Self-reported levels of heart feeling

    Time frame: On day 1.

    Self-reported levels of heart feeling will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."

  5. Self-reported levels of stomach feeling

    Time frame: On day 1.

    Self-reported levels of stomach feeling will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."

  6. State and Trait Anxiety questionnaires

    Time frame: On day 1.

    trait and state anxiety, assessed via the State-Trait Anxiety Inventory (STAI-S and STAI-T). State anxiety is assessed on a scale from "not at all" to "very much" on an 8-point scale, and trait anxiety is assessed on a scale from 0 to 3, with higher scores indicating higher anxiety.

  7. Affect questionnaire

    Time frame: On day 1.

    Positive and negative affect, assessed via the Positive and Negative Affect Schedule (PANAS). Responses range from "not at all" to "extremely" on a 5-point scale (from 0 to 5). Higher positive affect scores indicate greater positive affect, and higher negative affect scores indicate greater negative affect.

  8. Depression questionnaire

    Time frame: On day 1.

    Depressive symptoms, assessed via the Beck Depression Inventory (BDI). Items are rated from 0 to 3 based on how the participant felt during the past week including today, with higher scores indicating greater depressive symptoms.

  9. Personality questionnaire

    Time frame: On day 1.

    Personality traits, assessed via the Big Five Inventory (BFI-10). Responses range from "strongly disagree" to "strongly agree" on a 5-point scale (from 1 to 5). Higher subscale scores indicate greater levels of the corresponding personality trait.

  10. Impulsivity questionnaire

    Time frame: On day 1.

    Impulsivity, assessed via the Barratt Impulsivity Scale (BIS-15). Items are rated on a scale from 1 to 4, with higher scores indicating greater impulsivity.

  11. Self-control questionnaire

    Time frame: On day 1.

    Self-control, assessed via the Brief Self-Control Scale (BSCS). Responses range from "not at all" to "very much" on a 5-point scale (from 0 to 5), with higher scores indicating greater self-control.

  12. Behavioral inhibition and activation questionnaire

    Time frame: On day 1.

    Behavioral inhibition and activation, assessed via the BIS/BAS scales. Items are rated on a scale from 1 to 4, with higher scores indicating stronger inhibition or activation tendencies.

  13. Interoceptive awareness questionnaire

    Time frame: On day 1

    Interoceptive awareness, assessed via the Multidimensional Assessment of Interoceptive Awareness (MAIA). Responses range from "never" to "always" on a 6-point scale (from 0 to 5). Higher subscale scores indicate greater self-reported interoceptive awareness in the corresponding domain.

  14. Perceived stress questionnaire

    Time frame: On day 1.

    Perceived stress, assessed via the Perceived Stress Questionnaire (PSQ). Responses range from "almost never" to "usually" on a 4-point scale (from 0 to 5), referring to the past 4 weeks, with higher scores indicating greater perceived stress.

  15. Self-efficacy questionnaire

    Time frame: On day 1

    General self-efficacy, assessed via the Self-Efficacy Scale (SES). Responses range from "not at all true" to "exactly true" on a 4-point scale (from 1 to 4), with higher scores indicating greater self-efficacy.

  16. Mental well-being questionnaire

    Time frame: On day 1.

    Mental well-being, assessed via the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Responses range from "never" to "always" on a 5-point scale (from 1 to 5), with higher scores indicating greater mental well-being over the past 2 weeks.

  17. Loneliness questionnaire

    Time frame: On day 1

    Loneliness, assessed via the UCLA Loneliness Scale. Responses range from "not at all" to "completely" on a 5-point scale (from 1 to 5), with higher scores indicating greater loneliness.

  18. Resilience questionnaire

    Time frame: On day 1.

    Resilience, assessed via the Brief Resilience Scale (BRS). Responses range from "strongly disagree" to "strongly agree" on a 5-point scale (from 0 to 5), with higher scores indicating greater resilience.

  19. Social anxiety questionnaire

    Time frame: On day 1.

    Social anxiety, assessed via the Liebowitz Social Anxiety Scale (LSAS). Fear and avoidance are each rated on a scale from 0 to 3, with higher scores indicating greater social anxiety.

  20. Autism traits questionnaire

    Time frame: On day 1.

    Autism-related traits, assessed via the Autism-Spectrum Quotient (AQ-k). Items are rated on a 4-point scale (from 1 to 4), with higher scores indicating greater endorsement of autism-related traits.

  21. Physical activity questionnaire

    Time frame: On day 1.

    Physical activity, assessed via the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The questionnaire assesses the number of days and time spent in vigorous activity, moderate activity, walking, and sitting over the past 7 days, considering activities performed for at least 10 minutes without interruption. Higher values indicate greater reported activity or sedentary time in the respective domain.

  22. Sleep quality questionnaire

    Time frame: On day 1.

    leep quality, assessed via the Pittsburgh Sleep Quality Index (PSQI). The questionnaire assesses sleep habits over the past 4 weeks, including sleep timing, duration, disturbances, and subjective sleep quality. Several items are rated on 4-point scales, with higher scores indicating poorer sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Soyoung Q Park, Prof. Dr.

CONTACT

[email protected]

+49 033200 88 2510

Wenhao Huang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Registry information

Acronym: ProlEx-Context

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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