Clinical trial NCT05304000: Psychophysiological Effects of Controlled Respiration and Mindfulness
Official title: Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Stress, Emotional
Insomnia
Keywords: stress
breathwork
mindfulness meditation
mood
anxiety
wearable
physiology
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: State Anxiety
timeFrame: Daily from Day 0 to 29
measure: Trait Anxiety
timeFrame: Day 0 and Day 29 (Baseline and Endpoint)
measure: Positive Affect
timeFrame: Daily from Day 1 to 28
measure: Negative Affect
timeFrame: Daily from Day 1 to 28
measure: Daytime Sleep Related Disturbance
timeFrame: Day 0 and Day 29 (Baseline and Endpoint)
measure: Resting Heart Rate
timeFrame: Daily from Day 1 to 28
measure: Heart Rate Variability
timeFrame: Daily from Day 1 to 28
measure: Respiratory Rate
timeFrame: Daily from Day 1 to 28
measure: Sleep Duration
timeFrame: Daily from Day 1 to 28
measure: Change in number of hours of sleep
timeFrame: Daily from Day 1 to 28
measure: Change in the ratio of number of hours of sleep to hours in bed
timeFrame: Daily from Day 1 to 28
Secondary outcomes:
measure: Adherence to Protocol
timeFrame: Daily from Day 1 to 28
Other outcomes:
measure: Debriefing survey
timeFrame: Day 29 (study endpoint)
Locations:
city: Palo Alto
country: United States
facility: Neurobiology and Ophthalmology
state: California
city: Stanford
country: United States
facility: Dept. of Psychiatry, Stanford University
state: California
Study officials:
affiliation: Professor of Psychiatry, Stanford University
name: David Spiegel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Andrew Huberman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Manuela Kogon, M.D.
role: STUDY_DIRECTOR
References: