Quality of LifeProlEx-MRINCT05936684
Breathing and Decision-Making
A study testing Breathing with prolonged exhalation (ProlEx) during risky decision-making in people with Quality of Life and Behavior, run by German Institute of Human Nutrition at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Behavior, Stress, Psychological
- What is being tested?
- Breathing with prolonged exhalation (ProlEx) during risky decision-making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2023to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Normal vision (no glasses or contact lenses required)
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathing and Decision-Making: an FMRI Study Investigating the Link Between Slow Breathing and Risky Decision-Making
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.
Read the 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.
- Conditions
- Quality of Life, Behavior, Stress, Psychological
- Being tested
- Breathing with prolonged exhalation (ProlEx) during risky decision-making, Normal breathing (Eupnea/Control) during risky decision-making
- Keywords
- Breathing, Relaxation, Decision-Making, Stress Management
- Medical subject headings
- Behavior, Stress, Psychological, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing with prolonged exhalation (ProlEx) during risky decision-makingBehavioural
Also called ProlEx (decision-making), Slow Breathing
20 min divided in 3 blocks of slow, 0.1 Hz breathing (6 cycles per minute) with an inhalation-to-exhalation ratio of 2:8. Cue-assisted breathing (same across participants) and performance of a risky decision-making task (Tom et al., 2007) in the magnetic resonance imaging (MRI) scanner with simultaneous acquisition of physiological and pupil data.
Normal breathing (Eupnea/Control) during risky decision-makingBehavioural
Also called Eupnea (decision-making), Normal Breathing
20 min divided in 3 blocks of normal breathing (expected range: 0.16-0.33 Hz, i.e., 10-20 per min), Cue-assisted breathing (individually adapted) and performance of a risky decision-making task (Tom et al., 2007) in the MRI scanner with simultaneous acquisition of physiological and pupil data.
| Study group | Role | What they receive |
|---|---|---|
| Effect of ProlEx breathing on decision-making if applied before the Eupnea condition | Experimental | Intervention (behavioral): Block 1: ProlEx, Block 2: Eupnea/Control during decision-making Receives: Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making; Behavioral: Normal breathing (Eupnea/Control) during risky decision-making |
| Effect of Eupnea breathing on decision-making if applied before the ProlEx condition | Experimental | Intervention (behavioral): Block 1: Eupnea/Control, Block 2: ProlEx during decision-making Receives: Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making; Behavioral: Normal breathing (Eupnea/Control) during risky decision-making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior: Risk propensity
Risk propensity, i.e., the willingness to accept or reject a risky mixed gamble in an adapted paradigm based on Tom et al. (2007); assessed using response options "strongly accept", "weakly accept", "weakly reject", "strongly reject"
Measured: 1 year
Brain: blood-oxygen-level-dependent (BOLD) signal changes
BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI
Measured: 1 year
Body: Heart-rate variability
Low-frequency and high-frequency heart rate variability (LF-HRV and HF-HRV, respectively); assessed using an electrocardiogram (ECG) and pulse oximetry
Measured: 1 year
Body: Pupil
Miosis/mydriasis, i.e., changes in pupil dilation; assessed with eye tracking
Measured: 1 year
Body: Electrodermal activity
Tonic electrodermal activity (EDA); assessed using a galvanic skin response module
Measured: 1 year
Secondary outcomes (12)
Questionnaire assessing depression: "Beck Depression Inventory" (BDI)
The depression scale (self-report) will be assessed using Beck Depression Inventory (BDI) (Hautzinger et al., 1994). The questionnaire consists of 21 questions, with each item corresponding to a value ranging from 0 to 3. Higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered minimal, 14-19 mild, 20-28 moderate, and 29-63 severe.
Measured: 1 year
Questionnaire assessing personality traits: "Big Five Inventory" (BFI-10)
Personality traits (self-report) will be assessed using the Big Five Inventory (BFI-10) (Rammstedt et al., 2013). The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness. Ten items are answered on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree".
Scoring of the BFI-10 scales (R = item is reverse-scored): Extraversion: 1R, 5; Agreeableness: 2, 7R; Conscientiousness: 3R, 8; Neuroticism: 4R, 9; Openness to Experience: 5R, 10.
Individuals who score high on the BFI-10 tend to exhibit certain qualities associated with each of the personality traits. The score can range from a minimum of 2 to a maximum of 10 points for each of the personality traits.
Measured: 1 year
Questionnaire assessing impulsivity: "Barratt Impulsivity Scale" (BIS-15)
Impulsivity (self-report) will be assessed using the Barratt Impulsivity Scale (BIS-15) (Meule et al., 2011). This scale is a questionnaire consisting of 15 items scored from 1 to 4 with 1 = rarely / never, 2 = sometimes, 3 = often, and 4 = almost always / always. Scores range from 15 to 60, with higher scores reflecting greater impulsiveness.
Measured: 1 year
Questionnaire assessing approach-avoidance behavior: "Behavioral Inhibition System/Behavioral Approach System" (BIS/BAS)
Approach-avoidance behavior (self-report) will be assessed using the Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) (Strobel et al., 2001).
The BIS/BAS scale is a 24-item self-report questionnaire designed to measure two motivational systems. The behavioral inhibition system (BIS), which corresponds to the motivation to avoid aversive outcomes, has 7 items with a total score ranging from 7 to 28 points. The behavioral activation system (BAS), which corresponds to the motivation to approach goal-oriented outcomes,has 13 items with a total score ranging from 13 to 52 points. Four items act as filler items. Participants respond to each item using a 4-point Likert scale: 1 (very true for me), 2 (somewhat true for me), 3 (somewhat false for me), and 4 (very false for me). Total scores are calculated for BIS and BAS, with a higher score corresponding to higher behavioral inhibition and activation, respectively.
Measured: 1 year
Questionnaire assessing self-control: "Brief Self-Control Scale" (BSCS)
Self-control (self-report) will be assessed using the Brief Self-Control Scale (BSCS) (Sproesser et al., 2011). The BSCS measures trait self-control via items with a 5-point Likert scale, where 1 refers to 'not at all' and 5 to 'extremely'. Scores range from 13 to 65. Higher scores represent higher levels of self-control.
Measured: 1 year
Questionnaire assessing interoceptive awareness: "Multidimensional Assessment of Interoceptive Awareness" (MAIA-2)
Interoceptive Awareness (self-report) will be assessed using the "Multidimensional Assessment of Interoceptive Awareness" (MAIA-2) (Mehling et al., 2018). The MAIA assesses multidimensional aspects of self-reported interoception and includes 37 items using a six-point Likert scale (0 never, 5 always). Higher scores equate to higher awareness of bodily sensation.
The results from the MAIA-2 focus on the individual scale scores (Mehling et al., 2012).
Measured: 1 year
Questionnaire assessing affect: "Positive and Negative Affect Scale" (PANAS)
Affect (self-report) will be assessed using the Positive and Negative Affect Scale (PANAS) (Janke et al., 2014). The PANAS is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Score: the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Add the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 to 50, with lower scores representing lower levels of negative affect.
Measured: 1 year
Questionnaire assessing stress: "Perceived Stress Questionnaire" (PSQ)
Stress (self-report) will be assessed using the Perceived Stress Questionnaire (PSQ) (Fliege et al., 2001). The PSQ a self-report questionnaire that consists of 20 items. Each item is rated on a 4-point Likert scale of 1 to 4. Total scores range from 20 to 80. Higher scores indicate greater levels of stress.
Measured: 1 year
Questionnaire assessing self-efficacy: "General Self-Efficacy Scale" (GSE)
Self-efficacy (self-report) will be assessed using the General Self-Efficacy Scale (GSE) (Schwarzer et al., 1997). The GSE is a 10-item scale with a score for each item ranging from 1 to 4. Total scores range from 10 to 40. Higher scores indicate higher self-reported self-efficacy.
Measured: 1 year
Questionnaire assessing anxiety: "State-Trait Anxiety Inventory" (STAI-T)
Trait anxiety (self-report) will be assessed using the State-Trait Anxiety Inventory (STAI-T) (Grimm et al., 2009). The State-Trait Anxiety Inventory (STAI-T) is a 20-item scale with a score for each question ranging from 0 to 3. Total scores range from 0 to 60. Higher scores indicate higher levels of anxiety.
Measured: 1 year
Questionnaire assessing mentall well-being: "Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)
Mental well-being (self-report) will be assessed using the Warwick-Edinburgh Mental Well-Being Scale, short version (SWEMWBS) (Lang et al., 2017). The WEMWBS is scored by summing the responses to each of the 14 items on a 1 to 5 Likert scale. Total scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well-being.
Measured: 1 year
Body: Eye gaze
Eye fixation points analysed using eye-tracking data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start4 Jul 2023
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, German Center for Diabetes Research, Freie Universität Berlin
- Responsible party
- Principal investigator, Prof. Dr. Soyoung Q Park, German Institute of Human Nutrition
- Investigators
- Soyoung Q Park, Prof. Dr., Principal investigator, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936684
- Sponsor's protocol ID
- ProlEx-MRI
- Acronym
- ProlEx-MRI
- Status last verified
- Nov 2024
- First submitted
- 21 Jun 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fliege, H., Rose, M., Arck, P., Levenstein, S. & Klapp, B. F. (2001). Validierung des Perceived Stress Questionnaire (PSQ) an einer deutschen Stichprobe. Diagnostica, 47, 142-152.
Grimm, J. State-trait-anxiety inventory nach Spielberger. Deutsche Lang- und Kurzversion. Methodenforum der Universität Wien: MF-Working Paper (2009).
Hautzinger M. [The Beck Depression Inventory in clinical practice]. Nervenarzt. 1991 Nov;62(11):689-96. German.
PubMed 1770969Janke, S., & Glöckner-Rist, A. (2014). "Deutsche Version der Positive and Negative Affect Schedule (PANAS)" in Zusammenstellung sozialwissenschaftlicher Items und Skalen, GESIS (Mannheim, Germany). doi.org/10.6102/zis146
Lang, G. & Bachinger, A. Validation of the German Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) in a community-based sample of adults in Austria: a bi-factor modelling approach. J Public Health 25, 135-146 (2017)
Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
PubMed 30513087Meule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011).
Rammstedt, B., Kemper, C.J., Klein, M.C., Beierlein, C., & Kovaleva, A. (2013). Eine kurze Skala zur Mes-sung der fünf Dimensionen der Persönlichkeit. Methoden, Daten, Analysen, 7(2), S. 233-249
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.
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.
PubMed 17255512
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing and Decision-Making: an FMRI Study Investigating the Link Between Slow Breathing and Risky Decision-Making
- ClinicalTrials.gov ID
- NCT05936684
- Acronym / sponsor ID
- ProlEx-MRI / ProlEx-MRI
- Conditions
- Quality of Life, Behavior, Stress, Psychological
- Keywords
- Breathing, Relaxation, Decision-Making, Stress Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, German Center for Diabetes Research, Freie Universität Berlin
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 10 Jul 2023 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of ProlEx breathing on decision-making if applied before the Eupnea condition | Experimental | Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making, Behavioral: Normal breathing (Eupnea/Control) during risky decision-makingIntervention (behavioral): Block 1: ProlEx, Block 2: Eupnea/Control during decision-making |
| Effect of Eupnea breathing on decision-making if applied before the ProlEx condition | Experimental | Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making, Behavioral: Normal breathing (Eupnea/Control) during risky decision-makingIntervention (behavioral): Block 1: Eupnea/Control, Block 2: ProlEx during decision-making |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Normal vision (no glasses or contact lenses required)
Key exclusion criteria (21 listed)
- Smokers
- Extreme athletes
- Extensive lung function (e.g., professional musician, abnoedivers)
- Excessive stress
- Former or current physical or psychological illness (e.g., lung diseases)
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 |
|---|---|---|
| Breathing with prolonged exhalation (ProlEx) during risky decision-makingAlso: ProlEx (decision-making), Slow Breathing20 min divided in 3 blocks of slow, 0.1 Hz breathing (6 cycles per minute) with an inhalation-to-exhalation ratio of 2:8. Cue-assisted breathing (same across participants) and performance of a risky decision-making task (Tom et al., 2007) in the magnetic resonance imaging (MRI) scanner with simultaneous acquisition of physiological and pupil data. | Behavioural | Effect of Eupnea breathing on decision-making if applied before the ProlEx condition, Effect of ProlEx breathing on decision-making if applied before the Eupnea condition |
| Normal breathing (Eupnea/Control) during risky decision-makingAlso: Eupnea (decision-making), Normal Breathing20 min divided in 3 blocks of normal breathing (expected range: 0.16-0.33 Hz, i.e., 10-20 per min), Cue-assisted breathing (individually adapted) and performance of a risky decision-making task (Tom et al., 2007) in the MRI scanner with simultaneous acquisition of physiological and pupil data. | Behavioural | Effect of Eupnea breathing on decision-making if applied before the ProlEx condition, Effect of ProlEx breathing on decision-making if applied before the Eupnea condition |
Primary outcome
Behavior: Risk propensity
Time frame: 1 year
Risk propensity, i.e., the willingness to accept or reject a risky mixed gamble in an adapted paradigm based on Tom et al. (2007); assessed using response options "strongly accept", "weakly accept", "weakly reject", "strongly reject"
Brain: blood-oxygen-level-dependent (BOLD) signal changes
Time frame: 1 year
BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI
Body: Heart-rate variability
Time frame: 1 year
Low-frequency and high-frequency heart rate variability (LF-HRV and HF-HRV, respectively); assessed using an electrocardiogram (ECG) and pulse oximetry
Body: Pupil
Time frame: 1 year
Miosis/mydriasis, i.e., changes in pupil dilation; assessed with eye tracking
Body: Electrodermal activity
Time frame: 1 year
Tonic electrodermal activity (EDA); assessed using a galvanic skin response module
12 secondary outcomes
Questionnaire assessing depression: "Beck Depression Inventory" (BDI)
Time frame: 1 year
Questionnaire assessing personality traits: "Big Five Inventory" (BFI-10)
Time frame: 1 year
Questionnaire assessing impulsivity: "Barratt Impulsivity Scale" (BIS-15)
Time frame: 1 year
Questionnaire assessing approach-avoidance behavior: "Behavioral Inhibition System/Behavioral Approach System" (BIS/BAS)
Time frame: 1 year
Questionnaire assessing self-control: "Brief Self-Control Scale" (BSCS)
Time frame: 1 year
Questionnaire assessing interoceptive awareness: "Multidimensional Assessment of Interoceptive Awareness" (MAIA-2)
Time frame: 1 year
Questionnaire assessing affect: "Positive and Negative Affect Scale" (PANAS)
Time frame: 1 year
Questionnaire assessing stress: "Perceived Stress Questionnaire" (PSQ)
Time frame: 1 year
Questionnaire assessing self-efficacy: "General Self-Efficacy Scale" (GSE)
Time frame: 1 year
Questionnaire assessing anxiety: "State-Trait Anxiety Inventory" (STAI-T)
Time frame: 1 year
Questionnaire assessing mentall well-being: "Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)
Time frame: 1 year
Body: Eye gaze
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- BackgroundFliege, H., Rose, M., Arck, P., Levenstein, S. & Klapp, B. F. (2001). Validierung des Perceived Stress Questionnaire (PSQ) an einer deutschen Stichprobe. Diagnostica, 47, 142-152.
- BackgroundGrimm, J. State-trait-anxiety inventory nach Spielberger. Deutsche Lang- und Kurzversion. Methodenforum der Universität Wien: MF-Working Paper (2009).
- Background: PubMed 1770969Hautzinger M. [The Beck Depression Inventory in clinical practice]. Nervenarzt. 1991 Nov;62(11):689-96. German.
- BackgroundJanke, S., & Glöckner-Rist, A. (2014). "Deutsche Version der Positive and Negative Affect Schedule (PANAS)" in Zusammenstellung sozialwissenschaftlicher Items und Skalen, GESIS (Mannheim, Germany). doi.org/10.6102/zis146
- BackgroundLang, G. & Bachinger, A. Validation of the German Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) in a community-based sample of adults in Austria: a bi-factor modelling approach. J Public Health 25, 135-146 (2017)
- Background: PubMed 30513087Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
- BackgroundMeule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011).
- BackgroundRammstedt, B., Kemper, C.J., Klein, M.C., Beierlein, C., & Kovaleva, A. (2013). Eine kurze Skala zur Mes-sung der fünf Dimensionen der Persönlichkeit. Methoden, Daten, Analysen, 7(2), S. 233-249
- BackgroundSchwarzer, 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.
- Background: PubMed 17255512Tom 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Soyoung Q Park, Prof. Dr. principal investigator
German Institute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing with prolonged exhalation (ProlEx) during risky decision-making in people with Quality of Life and Behavior, run by German Institute of Human Nutrition at 1 site in Germany.
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 2 inclusion and 21 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: finished, as of the sponsor's last update on 9 Jan 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior: Risk propensity (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936684, which also lists 10 linked publications.
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 9 Jan 2025.