Psychophysiological Effects of Controlled Respiration and Mindfulness (PECRM)

Stanford University

Status: Completed

Conditions: Stress, Emotional; Insomnia; Stress, Physiological

Treatments: Behavioral: Cyclic Hyperventilation with Retention; Behavioral: Mindfulness Meditation; Behavioral: Cyclic Sighing Breathing; Behavioral: Box Breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT05304000

41398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 4 patient groups

Mindfulness Meditation

Active Comparator group

Description:

5 minutes a day of mindfulness meditation practice for 28 days (passive attention to breath) delivered remotely through a video link.

Treatment:

Behavioral: Mindfulness Meditation

Cyclic Sighing Breathing

Experimental group

Description:

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of slow inhales until lungs felt full then one more inhale to maximally fill the lungs, followed up a slow exhale. Repeat this cycle for 5 minutes.

Treatment:

Behavioral: Cyclic Sighing Breathing

Box Breathing

Experimental group

Description:

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of equal duration of inhale, hold, exhale, hold cycles. The duration of the cycle is determined by the participant's comfort level with holding. (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold). Repeat this cycle for 5 minutes.

Treatment:

Behavioral: Box Breathing

Cyclic Hyperventilation with Retention

Experimental group

Description:

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of 30 breaths (inhale deeply through the nose and exhale passively through the mouth) and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds. Repeat this cycle for 5 minutes.

Treatment:

Behavioral: Cyclic Hyperventilation with Retention