Psychophysiological Effects of Controlled Respiration and Mindfulness

Not Applicable

Completed

• Conditions: Stress, Physiological; Stress, Emotional; Insomnia

• Registration Number: NCT05304000
• Lead Sponsor: Stanford University

Brief Summary

The investigators aim to understand the effectiveness of 3 types of breathwork exercises and a mindfulness meditation control on improving psychological and physiological measures of wellbeing. The interventions will be delivered remotely and effects are monitored through daily surveys and physiological monitoring with WHOOP wristband through a 28-day period. The information gained will help develop the most effective remote interventions for lowering stress and improving wellbeing. The study will be run on a healthy general population. The three breathing conditions were 1) Cyclic Sighing, which emphasizes relatively prolonged exhalations, 2) Box Breathing, which is equal duration of inhalations, breath retentions, exhalations and breath retentions, and 3) Cyclic Hyperventilation with Retention, with longer, more intense inhalations and shorter, passive exhalations. Mindfulness Meditation practice involved passive attention to breath.

Detailed Description

PRIMARY OBJECTIVES:

I. Examine psychological and physiological effects of breathwork in general in comparison to mindfulness meditation.

SECONDARY OBJECTIVES:

I. Examine the effectiveness of specific breathwork protocols in improving mood and physiological wellness metrics in comparison to mindfulness meditation.

OUTLINE:

Of 140 potential participants who consented, 134 were randomized to the four interventions (3 were lost to follow-up and 3 were excluded due to lack of WHOOP straps at this stage). Out of the 134 that were randomized, 108 were enrolled. The primary reasons for attrition at this stage were due to pandemic-related reasons or loss of contact with the participants.

From the 108 subjects enrolled, 24 were randomized into the Mindfulness Meditation control condition and 84 were randomized to the treatment conditions (30 Cyclic Sighing, 21 Box Breathing, 33 Cyclic Hyperventilation with Retention). The initial randomization consisted of a permuted block randomization design with a block size of eight.

Both prior to and after the 28-day intervention, participants completed two brief questionnaires to assess the impact of the intervention on the daytime sequelae of sleep and anxiety: PROMIS Sleep Related Impairment - Short Form 8a, and the State-Trait Anxiety Questionnaire. Participants also completed a debriefing questionnaire at the end of the study. During the 28-day intervention period, participants did their assigned 5-minute exercise and completed two questionnaires before and after, the State Anxiety Inventory and the Positive and Negative Affect Schedule (PANAS). Participants received invitations to instructional videos (pre-recorded by Andrew D. Huberman) on the breathing exercises 3-5 days prior to the start of the study as well as daily text messages that reminded them to complete their exercises and pre-and-post-practice assessments. They were asked to complete the exercises only once a day.

Study Timeline

• Study Start: 2020-06-02
• Primary Completion: 2020-09-17
• Study Completion: 2020-09-17
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Age ≥ 18
• Not pregnant
• Able to follow basic instruction for prescreen and scheduling
• Compliant with investigator instructions during the consent process and participation in the study

Exclusion Criteria

• Age <18
• Pregnant
• Non-English speaking
• Anyone with personality disorders or psychosis such as schizoaffective disorder
• Demonstrates evidence of severe psychiatric disorder in prescreen or email contact (as judged by Dr. Spiegel)
• Glaucoma
• History of seizures
• Suicidal
• Heart disease (based on PI's clinical judgement, dependent on the severity of the symptoms)
• Current untreated psychosis, or bipolar disorder, or substance/alcohol abuse/dependence (based on PI's clinical judgement, dependent on the severity of the symptoms)
• Any Medical condition that could be exasperated by study participation (based on PI's clinical judgement)
• Non USA mailing address to receive the WHOOP strap
• Vision or hearing impairment severe enough to interfere with study participation,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	Daily from Day 1 to 28	Daily obtained from WHOOP wrist band
State Anxiety	Daily from Day 0 to 29	STAI State Trait Anxiety
Trait Anxiety	Day 0 and Day 29 (Baseline and Endpoint)	STAI State Trait Anxiety
Change in number of hours of sleep	Daily from Day 1 to 28	Daily obtained from WHOOP wrist band as Hours of Sleep. Changes in the hours of sleep will be assessed with more hours indicating better sleep.
Change in the ratio of number of hours of sleep to hours in bed	Daily from Day 1 to 28	Obtained daily from WHOOP wrist band as sleep efficiency. Changes in the Whoop Sleep Efficiency score will be assessed with higher score (ratio) indicating higher sleep efficiency.
Positive Affect	Daily from Day 1 to 28	PANAS Positive Affect
Heart Rate Variability	Daily from Day 1 to 28	Daily obtained from WHOOP wrist band
Sleep Duration	Daily from Day 1 to 28	Daily obtained from WHOOP wrist band
Daytime Sleep Related Disturbance	Day 0 and Day 29 (Baseline and Endpoint)	PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Sleep Related Impairment Short Form 8a
Resting Heart Rate	Daily from Day 1 to 28	Daily obtained from WHOOP wrist band
Negative Affect	Daily from Day 1 to 28	PANAS Negative Affect

Secondary Outcome Measures

Name	Time	Method
Adherence to Protocol	Daily from Day 1 to 28	Number of days subjects did their exercises out of the 28 days assigned

Trial Locations

Locations (2)

Neurobiology and Ophthalmology; 🇺🇸 Palo Alto, California, United States

Dept. of Psychiatry, Stanford University; 🇺🇸 Stanford, California, United States