Comparative Effects of Four Brief Breathwork and Mindfulness Interventions on Anxiety and Psychological Flexibility: A 4-Arm RCT (BREATH-4)
2. juni 2026 oppdatert av: Isaac Carmona-Rincón, Valencian International University (VIU)
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
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Isaac Carmona-Rincón, PhD
- Telefonnummer: +34 618 187 325
- E-post: isaac.carmona@professor.universidadviu.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age between 18 and 65 years (inclusive)
- Native Spanish speaker or fluent in Spanish (sufficient to understand audio instructions and complete psychometric questionnaires)
- Stable internet access and an electronic device (smartphone, tablet, or computer)
- Ability to provide informed consent and commitment to the 31-day protocol and 2-month follow-up
Exclusion Criteria:
- Active diagnosis of severe or chronic respiratory disease that prevents safe performance of breathing exercises (e.g., advanced COPD, severe uncontrolled asthma, cystic fibrosis)
- Current diagnosis of severe psychiatric disorder (e.g., psychotic spectrum disorders, acute-phase bipolar disorder, severe major depression with suicidal risk)
- Any acute medical condition contraindicated for voluntary alteration of breathing patterns
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Box Breathing
Daily 5-minute box breathing with individualized timing based on a CO2 tolerance test.
Participants perform a maximal exhale and record the duration; this determines their personal inhale/hold/exhale/hold intervals (3-4s, 5-6s, or 8-10s).
Equal-phase cyclic breathing with exclusive focus on mechanical control and counting.
|
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.
|
|
Eksperimentell: Cyclic Sighing
Daily 5-minute cyclic sighing.
Participants inhale slowly through the nose, then take a second shorter nasal inhale to maximally fill the lungs, followed by a slow, complete oral exhalation.
This double-inhale/long-exhale pattern is repeated continuously for 5 minutes.
No mindfulness or attentional instructions are given.
|
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.
|
|
Eksperimentell: Mindfulness AH Exhalation
Daily 5-minute focused-attention mindfulness practice.
Participants sit or lie down, close their eyes, and direct attention to the forehead region between the eyes.
On each exhale, they softly vocalize the syllable "AH" aloud (gentle, unforced audible sound).
When distracted, they use the internal label "thinking-thinking" and redirect attention to the breath and then to the forehead region.
Practice continues for 5 minutes.
|
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.
|
|
Eksperimentell: Mindful Cyclic Sighing
Daily 5-minute hybrid practice combining cyclic sighing mechanics with mindfulness instructions.
Participants inhale slowly through the nose, take a second shorter nasal inhale to maximally fill the lungs, then exhale slowly while softly vocalizing the syllable "AH" aloud (gentle, unforced).
Attention is directed to the breath and the sensation of release during exhalation.
When distracted, participants use the internal label "thinking-thinking" and redirect attention back to the breath.
Practice continues 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
State Anxiety (STAI-E)
Tidsramme: 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).
|
Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Positive and Negative Affect (PANAS)
Tidsramme: 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).
|
Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
|
Psychological Flexibility (MPFI-24)
Tidsramme: 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).
|
Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
|
|
Psychological Flexibility (Psy-Flex)
Tidsramme: 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).
|
Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
|
Trait Anxiety (STAI-R)
Tidsramme: 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).
|
Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Resting Heart Rate (RHR)
Tidsramme: 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.
|
Daily (Days 1-28)
|
|
Heart Rate Variability (HRV)
Tidsramme: 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.
|
Daily (Days 1-28)
|
|
Respiratory Rate (RR)
Tidsramme: 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.
|
Daily (Days 1-28)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Isaac Carmona-Rincón, PhD, Valencian International University (VIU)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.
- Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomized trials. Nat Med. 2025 Jun;31(6):1784-1792. doi: 10.1038/s41591-025-03668-w. Epub 2025 Apr 29.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. januar 2027
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VIU-BREATH-RCT-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymized individual participant data (IPD) and the data dictionary will be made available upon reasonable request to the principal investigator (isaac.carmona@professor.universidadviu.com).
Requests will be evaluated on a case-by-case basis.
IPD-delingstidsramme
Beginning 6 months after publication of primary results, available for 5 years
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal.
Data shared under a data sharing agreement ensuring confidentiality and appropriate use.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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