Stress Management Program

Not Applicable

Recruiting

• Conditions: Stress; Anxiety
• Interventions: Behavioral: Audiobook; Behavioral: Box Breathing; Behavioral: Hypnosis; Behavioral: Cyclic Sighing Breathing

• Registration Number: NCT06526585
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-30
• Study Start: 2025-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audiobook on Stress	Audiobook	Ten minutes a day of listening to sections of an audiobook about stress for 28 days (passive listening) delivered remotely through an audio link. Participants will also listen to the 10 minute segments during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days.
Box Breathing	Box Breathing	Ten minutes a day of active breathwork practice for 28 days delivered remotely through a video link. Participants will also practice 10 minutes of active breathwork during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days.
Hypnosis	Hypnosis	Ten minutes a day of hypnosis practice for 28 days delivered remotely through an audio link. Participants will also practice 10 minutes of hypnosis during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days
Cyclic Sighing Breathing	Cyclic Sighing Breathing	Ten minutes a day of active breathwork practice for 28 days delivered remotely through a video link. Participants will also practice 10 minutes of active breathwork during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days.

Primary Outcome Measures

Name	Time	Method
Neural Activation	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).

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate	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.
Heart Rate Variability	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.
State Anxiety scale score	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.

Trial Locations

Locations (1)

Psychiatry & Behavioral Sciences; 🇺🇸 Stanford, California, United States