NCT05266833

Brief Summary

The purpose of this study was to test a simple slow breathing curriculum for reducing stress among high school students. The curriculum was developed by the Health and Human Performance Foundation and implemented for this study at a public high school in Colorado, United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

13 days

First QC Date

February 10, 2022

Last Update Submit

March 1, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Feasibility - compliance with breathing curriculum

    Number of participants completing the breathing practices

    5 weeks

  • Feasibility - compliance with effectiveness assessments

    Number of participants completing the STAI and CO2TT assessments

    7.5 weeks

  • Feasibility - curriculum ease and tolerability

    Ease and tolerability of the breathing curriculum was measured as the average ratings on a scale of 0 to 3 (worst to best) of responses about the curriculum's ease, usefulness, and tolerability.

    1-week followup period

  • Feasibility - effectiveness assessments ease and tolerability

    Ease and tolerability of the preliminary effectiveness assessments was measured as the average ratings on a scale of 0 to 3 (worst to best) of responses about the effectiveness assessments' ease and tolerability.

    1-week followup period

Secondary Outcomes (2)

  • Change in in-the-moment stress levels from before to after breathing exercises, as measured by the State-Trait Anxiety Inventory, State (STAI-State) Scale, short version.

    5 weeks

  • Change in general stress levels from before to after the 5-week curriculum, as measured by the State-Trait Anxiety Inventory, Trait (STAI-Trait) Scale.

    1.5-week baseline period and 1-week followup period

Study Arms (3)

Control

NO INTERVENTION

Students in the control class received regular class instruction during the 5 weeks. This instruction did not deviate from regular instruction that was provided to all classes, including the intervention classes. During the intervention period, control group students completed the assessments once per week. The control class is considered a treatment-as-usual active control.

Self-Paced Breathing

EXPERIMENTAL

The self-paced slow diaphragmatic breathing intervention provided guidance for participants to breathe at a slower pace than normal with brief, organic pauses after each inhale and exhale, and with exhales longer than inhales. Participants were guided to breathe at their own pace while following these principles of longer exhales and brief pauses after each inhale/exhale. They were invited to slow their pace when ready, both during each 5-minute session and over the course of the 5 weeks.

Behavioral: Slow diaphragmatic breathing

Guide-Paced Breathing

EXPERIMENTAL

The guide-paced slow diaphragmatic breathing intervention comprised slow breathing with all exhales twice as long as the inhales; e.g., a 3-second inhale was followed by a 6-second exhale. Participants were instructed to breathe in sync with the guided pace. The breathing pace slowed over the 5 weeks: for weeks 1-2, the breath pattern comprised a 3-second inhale followed by a 6-second exhale; for weeks 3-4, the timing was 4 and 8, respectively; and was 5 and 10 for the last week.

Behavioral: Slow diaphragmatic breathing

Interventions

The curriculum was based on three key breathing components that have been shown to reduce stress in adolescents: slow breathing; diaphragmatic breathing; and extended exhale breathing. Slow breathing entails breathing at a pace slower than normal breathing. Diaphragmatic breathing focuses on breaths starting from the diaphragm or abdominal areas, with abdominal, then lung, then chest expansion during the inhale and a slow, gradual, full release of air in the reverse direction on the exhale. Extended exhale breathing comprises breathing with the exhalation duration longer, often twice as long, as the inhalation. Two versions of slow diaphragmatic extended exhale breathing were included in this study. For both, participants did the practice while seated comfortably and breathing through the nose, and were guided to increase the inhale and exhale durations over the 5 weeks. Students followed 5-minute videos for each session.

Guide-Paced BreathingSelf-Paced Breathing

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Were enrolled at study start (baseline period) in one of four senior (12th grade) English classes taught by the teacher who was recruited for the study;
  • Accepted participation in the study, including willingness to abide by the randomization process, by signing student assent on the consent form;
  • Had parental permission to participate in the study, indicated by their signing their consent on the consent form.

You may not qualify if:

  • Chose not to participate; or,
  • Did not receive parental permission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspen High School

Aspen, Colorado, 81611, United States

Location

Related Publications (1)

  • Bentley TGK, Seeber C, Hightower E, Mackenzie B, Wilson R, Velazquez A, Cheng A, Arce NN, Lorenz KA. Slow-Breathing Curriculum for Stress Reduction in High School Students: Lessons Learned From a Feasibility Pilot. Front Rehabil Sci. 2022 Jul 1;3:864079. doi: 10.3389/fresc.2022.864079. eCollection 2022.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Tanya GK Bentley, PhD

    Health and Human Performance Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

March 4, 2022

Study Start

January 20, 2021

Primary Completion

February 2, 2021

Study Completion

March 29, 2021

Last Updated

March 4, 2022

Record last verified: 2022-03

Locations