An interventional study of Slow diaphragmatic breathing in Anxiety and Stress, sponsored by Health and Human Performance Foundation. Completed at 1 site in United States. Open to participants aged 16 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-04.
Sponsored by Health and Human Performance Foundation · Not applicable, Interventional, and Other
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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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Health and Human Performance Foundation as lead sponsor.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria: Students were eligible to participate in this study if they:
Exclusion Criteria: Students were excluded from the study and data collection, but not from class, if they:
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.
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
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
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.
Feasibility - compliance with breathing curriculum
Number of participants completing the breathing practices
Time frame: 5 weeks
Feasibility - compliance with effectiveness assessments
Number of participants completing the STAI and CO2TT assessments
Time frame: 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.
Time frame: 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.
Time frame: 1-week followup period
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.
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.
Time frame: 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.
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.
Time frame: 1.5-week baseline period and 1-week followup period
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2021 to primary completion in Feb 2021, 0 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 0 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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