Stress Management Program

NCT06526585 | Recruiting

• 1 other identifier: 72131
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Anxiety

Keywords

Stress; Breathwork; Cyclic Sighing; Box Breathing; Hypnosis; Mood; Anxiety; Physiology; Heart Rate Variability; Respiratory Rate; fMRI; Brain Activity; Sleep

Outcome Measures

Primary Outcomes (2)

• Neural Activation

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

  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

  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.

  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 Outcomes (2)

• Respiratory Rate

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

• 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)

Study Arms (4)

Cyclic Sighing Breathing

EXPERIMENTAL

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.

Behavioral: Cyclic Sighing Breathing

Box Breathing

EXPERIMENTAL

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.

Behavioral: Box Breathing

Hypnosis

EXPERIMENTAL

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

Behavioral: Hypnosis

Audiobook on Stress

ACTIVE COMPARATOR

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.

Behavioral: Audiobook

Interventions

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.

Cyclic Sighing Breathing

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.

Box Breathing

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.

Hypnosis

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.

Audiobook on Stress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Psychiatry & Behavioral Sciences

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Hypnosis; Sound Recordings

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• David Spiegel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bita Nouriani, MS

CONTACT

(650) 723-8479; bita@stanford.edu

Cassidy Kinderman, BA

CONTACT

‪(650) 260-8766‬; ckinder@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences, Stanford University

Model Details: Randomized prospective

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: March 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)