Comparative Effects of Four Brief Breathwork and Mindfulness Interventions on Anxiety and Psychological Flexibility: A 4-Arm RCT (BREATH-4)
2 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
240
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Isaac Carmona-Rincón, PhD
- Número de teléfono: +34 618 187 325
- Correo electrónico: isaac.carmona@professor.universidadviu.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
|
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Experimental: 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.
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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.
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Experimental: 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.
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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.
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Experimental: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
State Anxiety (STAI-E)
Periodo de tiempo: Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
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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).
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Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Positive and Negative Affect (PANAS)
Periodo de tiempo: 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).
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Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
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Psychological Flexibility (MPFI-24)
Periodo de tiempo: 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).
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Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
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Psychological Flexibility (Psy-Flex)
Periodo de tiempo: Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up
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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).
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Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up
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Trait Anxiety (STAI-R)
Periodo de tiempo: Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
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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).
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Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Resting Heart Rate (RHR)
Periodo de tiempo: 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.
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Daily (Days 1-28)
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Heart Rate Variability (HRV)
Periodo de tiempo: Daily (Days 1-28)
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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.
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Daily (Days 1-28)
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Respiratory Rate (RR)
Periodo de tiempo: Daily (Days 1-28)
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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.
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Daily (Days 1-28)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Isaac Carmona-Rincón, PhD, Valencian International University (VIU)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VIU-BREATH-RCT-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of primary results, available for 5 years
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound proposal.
Data shared under a data sharing agreement ensuring confidentiality and appropriate use.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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