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Recruiting NCT06526585

Stress Management Program

No phase Interventional Stress Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyclic Sighing Breathing, Box Breathing, Hypnosis, Audiobook.
Who it may be relevant to
Registry conditions: Stress, Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Cyclic Sighing Breathing
    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 followe
  • Behavioral Box Breathing
    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 tec
  • Behavioral Hypnosis
    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 rela
  • Behavioral Audiobook
    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 outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (2)
  • Respiratory Rate [Time frame: Daily from Baseline (Day 0) to a day prior to Endpoint (Day 28)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Psychiatry & Behavioral Sciences — Stanford

Identifiers

NCT: NCT06526585 · 72131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗