Clinical trial NCT05936684: Breathing and Decision-Making
Official title: Breathing and Decision-Making: an FMRI Study Investigating the Link Between Slow Breathing and Risky Decision-Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Behavior
Stress, Psychological
Keywords: Breathing
Relaxation
Decision-Making
Stress Management
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: German Center for Diabetes Research
name: Freie Universität Berlin
First posted: 2023-07-10
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate how slow breathing with prolonged exhalation (i.e., ProlEx breathing) modulates decision-making under risk in healthy participants. To do this, a short-term breathing intervention is combined with a decision-making paradigm while neural, physiological, and behavioral data are recorded.

Detailed description: This interventional study investigates the modulatory effect of slow breathing with prolonged exhalation (i.e., ProlEx breathing) on decision-making under risk. Using functional magnetic resonance imaging (fMRI), the researchers seek to identify brain regions influenced by the breathing intervention during the decision-making task.

Sixty healthy participants will be invited to perform ProlEx breathing during a risky decision-making task. After initial preparations, each individual's spontaneous breathing rhythm will be determined (i.e., Eupnea, control condition). This step is to i) ensure a natural breathing pace for each participant and ii) incorporate cue-assisted breathing into the control condition to allow comparability across conditions. To further investigate the effect of ProlEx on sympathovagal tone, physiological measures of respiration, electrocardiogram, pulse, electrodermal activity, and pupil are acquired. During scanning, the participant will perform a decision-making task based on the paradigm by Tom et al. (2007). The breathing intervention is applied simultaneously with continuous cue-assisted breathing for both conditions (Eupnea, ProlEx) throughout the duration of the task. The experiment follows a block design with counterbalanced orders to control for confounding effects. After completion of the scans, the participants fill out additional questionnaires.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Normal vision (no glasses or contact lenses required)

Exclusion Criteria:

* Smokers
* Extreme athletes
* Extensive lung function (e.g., professional musician, abnoedivers)
* Excessive stress
* Former or current physical or psychological illness (e.g., lung diseases)
* Current or previous medication within 2 weeks before the appointment
* Left-handedness
* Claustrophobia
* Tinnitus
* Non-removable metal parts or implants inside or on the body (e.g., hip replacements, copper IUD)
* Non-removable ferromagnetic objects inside or on the body (e.g., joint replacements)
* Non-removable magnetic objects inside or on the body (e.g., artificial eye)
* Large tattoos
* Young (\>18 years) or old (\>40 years) subjects
* Over- or underweight (BMI \<18 or \>25 kg/m2)
* Pregnancy
* Abnormal circadian rhythm (e.g., during shift work)
* Excessive alcohol consumption
* Illegal drug consumption within 2 weeks before the appointment
* Missing consent to participate
* Missing consent to receive incidental findings (MRI)

Primary outcomes:
measure: Behavior: Risk propensity
timeFrame: 1 year
measure: Brain: blood-oxygen-level-dependent (BOLD) signal changes
timeFrame: 1 year
measure: Body: Heart-rate variability
timeFrame: 1 year
measure: Body: Pupil
timeFrame: 1 year
measure: Body: Electrodermal activity
timeFrame: 1 year
Secondary outcomes:
measure: Questionnaire assessing depression: "Beck Depression Inventory" (BDI)
timeFrame: 1 year
measure: Questionnaire assessing personality traits: "Big Five Inventory" (BFI-10)
timeFrame: 1 year
measure: Questionnaire assessing impulsivity: "Barratt Impulsivity Scale" (BIS-15)
timeFrame: 1 year
measure: Questionnaire assessing approach-avoidance behavior: "Behavioral Inhibition System/Behavioral Approach System" (BIS/BAS)
timeFrame: 1 year
measure: Questionnaire assessing self-control: "Brief Self-Control Scale" (BSCS)
timeFrame: 1 year
measure: Questionnaire assessing interoceptive awareness: "Multidimensional Assessment of Interoceptive Awareness" (MAIA-2)
timeFrame: 1 year
measure: Questionnaire assessing affect: "Positive and Negative Affect Scale" (PANAS)
timeFrame: 1 year
measure: Questionnaire assessing stress: "Perceived Stress Questionnaire" (PSQ)
timeFrame: 1 year
measure: Questionnaire assessing self-efficacy: "General Self-Efficacy Scale" (GSE)
timeFrame: 1 year
measure: Questionnaire assessing anxiety: "State-Trait Anxiety Inventory" (STAI-T)
timeFrame: 1 year
measure: Questionnaire assessing mentall well-being: "Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)
timeFrame: 1 year
measure: Body: Eye gaze
timeFrame: 1 year
Other outcomes:
Locations:
city: Nuthetal
country: Germany
facility: German Institute of Human Nutrition
Study officials:
affiliation: German Institute of Human Nutrition
name: Soyoung Q Park, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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citation: Schwarzer, R., Bäßler, J., Kwiatek, P., Schröder, K., & Zhang, J. X. (1997). The assessment of optimistic self-beliefs: comparison of the German, Spanish, and Chinese versions of the general self-efficacy scale. Applied Psychology, 46(1), 69-88.
citation: Tom SM, Fox CR, Trepel C, Poldrack RA. The neural basis of loss aversion in decision-making under risk. Science. 2007 Jan 26;315(5811):515-8. doi: 10.1126/science.1134239.