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Completed

NCT Number: NCT05266833

Breathing for Adolescent Stress Reduction Feasibility RCT

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Stress

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aspen High School

Aspen, Colorado, 81611, United States

About this study

Nearly 1 in 3 US adolescents meet the criteria for anxiety, an issue worsened by the COVID-19 pandemic. Untreated adolescent stress and anxiety can adversely affect teenagers' development, education, and physical and mental health. Although stress-management strategies may seem abundant, many are unscalable or inaccessible for today's youth. Slow diaphragmatic breathing reduces stress and anxiety by downregulating the body's stress response, and is a recommended adolescent stress management strategy. Schools are under pressure to support students in reducing stress, yet diaphragmatic breathing practices are rarely used in school settings. The investigators developed and implemented a 5-week curriculum during COVID-era hybrid learning to conduct the first randomized controlled trial of slow diaphragmatic breathing for stress reduction in a US high school setting.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Students were eligible to participate in this study if they:

  • 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.

Exclusion criteria

Students were excluded from the study and data collection, but not from class, if they:

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

Treatment and study plan

Slow diaphragmatic breathing

Behavioral

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.

Primary outcomes

  1. Feasibility - compliance with breathing curriculum

    Time frame: 5 weeks

    Number of participants completing the breathing practices

  2. Feasibility - compliance with effectiveness assessments

    Time frame: 7.5 weeks

    Number of participants completing the STAI and CO2TT assessments

  3. Feasibility - curriculum ease and tolerability

    Time frame: 1-week followup period

    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.

  4. Feasibility - effectiveness assessments ease and tolerability

    Time frame: 1-week followup period

    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.

Secondary outcomes

  1. 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.

    Time frame: 5 weeks

    6-item STAI-State, short version scale. Responses are scored from 1 to 4. Final scores range from 6 to 24, with higher scores reflecting higher levels of in-the-moment anxiety.

  2. 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.

    Time frame: 1.5-week baseline period and 1-week followup period

    20-item STAI-Trait scale. Responses are scored from 1 to 4. Final scores range from 20 to 80, with higher scores reflecting higher levels of general anxiety.

Sponsors and collaborators

Lead sponsor

Health and Human Performance Foundation

Other

Registry information

Official study title

Slow-Breathing Curriculum for Stress Reduction in High School Students: A Feasibility Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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