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NCT Number: NCT06526585

Stress Management Program

This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatry & Behavioral Sciences

Stanford, California, 94305, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • No contraindications to MRI imaging (like ferromagnetic metal in their body)

Exclusion criteria

  • Pregnant or planning to get pregnant during study participation.
  • Not able or willing to come to research location twice for MRI assessments

Treatment and study plan

Cyclic Sighing Breathing

Behavioral

Participants are instructed to be seated or lying down, and can keep their eyes open or closed throughout the 10 minutes of the breathing practice during the 28 days. Participants are instructed to keep their eyes closed when practicing the 10 minutes of the cyclic sighing during the 2 MRI assessments.

The cyclic sighing protocol consists of a breathing pattern that involves inhaling deeply, starting abdominally, inhaling through the nose until lungs feel comfortably filled, immediately followed by a second shorter inhale, also through the nose, to maximally inflate the lungs. Then participants are instructed to slowly exhale through the mouth until their lungs feel empty. This cycle is repeated for 10 minutes.

Box Breathing

Behavioral

Participants are instructed to be seated or lying down, and can keep their eyes open or closed throughout the 10 minutes of the breathing during the 28 days. Participants are instructed to keep their eyes closed when practicing the 10 minutes of the box breathing during the 2 MRI assessments.

The CO2 tolerance test is done at baseline to determine their comfort level with the duration of each side of the box during box breathing.

The box breathing protocol consists of a four-part breathing technique. The practice involves breathing through the nose in four equally timed parts: inhale, hold, exhale, and hold again, forming a 'box' of breaths (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold).This cycle is repeated for 10 minutes.

hypnosis

Behavioral

Participants are instructed to sit comfortably or lie down during the 28 day at home practice (Participants will be lying down in the scanner during the 2 MRIs). Then participants are asked to look up, slowly close their eyes, take a deep breath, slowly exhale, and let their body float, and then to imagine floating in a bath, a lake, a hot tub, or floating in space. Participants are then asked to picture an imaginary screen and visualize a place where it would naturally feel comfortable and relaxed. The participants then divide the screen in half and picture on the left side one thing that is causing them stress, with the rule that no matter what the participant picture, to keep their body comfortable and relaxed. Then on the right side of the screen the participants are asked to picture one thing that can be done about the problem on the left. At the end the participant will be guided to come out of the state of hypnosis. This exercise will take 10 minutes.

Audiobook

Behavioral

Participants are instructed to be seated or lying down, and can keep eyes open or closed throughout the 10 minutes of listening to the audiobook during the 28 days. Participants are instructed to keep their eyes closed during the 2 MRI assessments.

Primary outcomes

  1. Neural Activation

    Time frame: Baseline Scan (Day 0) and and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability)

    As measured for example by Fractional amplitude of low-frequency fluctuation (fALFF) signal, assessed using functional Magnetic Resonance Imaging (fMRI).

  2. State Anxiety scale score

    Time frame: Immediate: Baseline Scan (Day 0) and Follow-up Scan (from day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)

    The State-Trait Anxiety Inventory (STAI) is an instrument for measuring anxiety in adults. It has 2 scales: State Anxiety (S-Anxiety) and Trait Anxiety (T-Anxiety). The S-Anxiety scale measures anxiety due to temporary conditions, and the T-Anxiety measures anxiety on a general or more long-standing scale. The S-Anxiety is a 20-item scale; each item yields a score of 1 to 4. Scores on the STAI S-Anxiety scale increase in response to physical danger and psychological stress and decrease as a result of relaxation training.

Secondary outcomes

  1. Respiratory Rate

    Time frame: Daily from Baseline (Day 0) to a day prior to Endpoint (Day 28)

    Daily respiratory rate (RR) will be collected by WHOOP Strap 2.0, a wearable photoplethysmography (PPG) wrist sensor.

  2. Heart Rate Variability

    Time frame: Immediate: Baseline Scan (Day 0) and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)

    Heart rate variability (HRV) will be measured in two modalities. Immediate continuous HRV, collected during resting-state MRI scans, will be measured by a wearable photoplethysmography (PPG) finger sensor. Daily HRV over the 28-day training period (RMSSD) will be collected by WHOOP Strap 2.0, a wearable PPG wrist sensor.

Study contacts

Contact information is provided by the study sponsor or research team.

Bita Nouriani, MS

CONTACT

[email protected]

(650) 723-8479

Cassidy Kinderman, BA

CONTACT

[email protected]

‪(650) 260-8766‬

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Examining the Immediate and Training Effects of Regular Stress Reduction Practices on Psychophysiological Markers of Anxiety

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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