NCT Number: NCT07621042
This four-arm, single-blind randomized controlled trial examines the effects of four brief daily 5-minute practices over 28 days on psychological flexibility and physiological variables in Spanish-speaking adults. Participants will be randomly assigned to one of four groups: Box Breathing, Cyclic Sighing, Mindfulness focused on exhalation with the syllable "AH", or Conscious Cyclic Sighing. Outcomes include state and trait anxiety (STAI), positive and negative affect (PANAS), psychological flexibility (MPFI-24, Psy-Flex), and physiological variables (heart rate, respiratory rate, heart rate variability). Assessments are conducted at baseline, daily during the 28-day intervention, at post-intervention (day 31), and at 2-month follow-up.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individualized box breathing based on CO2 tolerance test. Participants perform a maximal exhale and record the duration (CO2 discard time) to determine their personal cycle interval: 3-4s (0-20s discard), 5-6s (25-45s discard), or 8-10s (50-75s+ discard). Equal-phase cycles of inhale/hold/exhale/hold repeated for 5 minutes daily. Focus on mechanical breath control only.
Double nasal inhalation (slow deep inhale + short top-up inhale to maximal lung capacity) followed by slow complete oral exhalation. Repeated continuously for 5 minutes daily. No attentional instructions.
Focused-attention practice with eyes closed. Attention directed to forehead region between the eyes. Each exhalation accompanied by soft audible vocalization of syllable "AH". Distractions managed with internal label "thinking-thinking" followed by attention redirection. Practiced daily for 5 minutes.
Hybrid practice: double nasal inhalation (cyclic sighing mechanics) combined with slow exhalation vocalized as soft audible "AH". Mindfulness instructions include attention to breath sensations and use of "thinking-thinking" label upon distraction. Practiced daily for 5 minutes.
Time frame: Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
State anxiety measured with the State-Trait Anxiety Inventory - State subscale (STAI-E). 20 items rated on a 4-point Likert scale (0-3). Higher scores indicate greater anxiety. Spanish validated version (Guillen-Riquelme & Buela-Casal, 2011).
Time frame: Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
Positive and negative affect measured with the Positive and Negative Affect Schedule (PANAS). 20 items rated on a 5-point Likert scale. Two subscales: Positive Affect (PA) and Negative Affect (NA). Spanish validated version (Lopez-Gomez et al., 2015).
Time frame: Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
Multidimensional psychological flexibility and inflexibility measured with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). 24 items rated on a 6-point Likert scale assessing 12 Hexaflex processes. Spanish validated version (Navarrete et al., 2024).
Time frame: Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up
Unified psychological flexibility measured with the Psy-Flex scale. 6 items rated on a 5-point Likert scale. A modified daily version will be used during the intervention period. Spanish validated version (Navarrete et al., 2024).
Time frame: Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
Trait anxiety measured with the State-Trait Anxiety Inventory - Trait subscale (STAI-R). 20 items rated on a 4-point Likert scale (0-3). Higher scores indicate greater trait anxiety. Spanish validated version (Guillen-Riquelme & Buela-Casal, 2011).
Time frame: Daily (Days 1-28)
Resting heart rate in beats per minute (bpm) obtained from participants' personal wearable devices (smartwatch/fitness tracker). Change calculated as the slope of a linear regression fitted to daily values over the 28-day period.
Time frame: Daily (Days 1-28)
Heart rate variability obtained from participants' personal wearable devices during deep sleep. Change calculated as the slope of a linear regression fitted to daily values over the 28-day period. Only available for participants with compatible devices.
Time frame: Daily (Days 1-28)
Respiratory rate in breaths per minute obtained from participants' personal wearable devices. Change calculated as the slope of a linear regression fitted to daily values over the 28-day period. Only available for participants with compatible devices.
Contact information is provided by the study sponsor or research team.
Valencian International University (VIU)
Other
Effect of Brief Breathwork and Mindfulness Interventions on Anxiety, Psychological Flexibility and Physiological Variables in Spanish-Speaking University Students: a Four-Arm Randomized Controlled Trial
Acronym: BREATH-4
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