Comparative Effects of Four Brief Breathwork and Mindfulness Interventions on Anxiety and Psychological Flexibility: A 4-Arm RCT (BREATH-4)
2 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
240
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Isaac Carmona-Rincón, PhD
- Numero di telefono: +34 618 187 325
- Email: isaac.carmona@professor.universidadviu.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
State Anxiety (STAI-E)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Positive and Negative Affect (PANAS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Resting Heart Rate (RHR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Isaac Carmona-Rincón, PhD, Valencian International University (VIU)
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 gennaio 2027
Completamento primario (Stimato)
1 marzo 2027
Completamento dello studio (Stimato)
1 maggio 2027
Date di iscrizione allo studio
Primo inviato
27 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
27 maggio 2026
Primo Inserito (Effettivo)
2 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VIU-BREATH-RCT-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Beginning 6 months after publication of primary results, available for 5 years
Criteri di accesso alla condivisione IPD
Researchers who provide a methodologically sound proposal.
Data shared under a data sharing agreement ensuring confidentiality and appropriate use.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .