Breathing for Adolescent Stress Reduction Feasibility RCT

Not Applicable

Completed

• Conditions: Stress; Anxiety
• Interventions: Behavioral: Slow diaphragmatic breathing

• Registration Number: NCT05266833
• Lead Sponsor: Health and Human Performance Foundation

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-20
• Primary Completion: 2021-02-02
• Study Completion: 2021-03-29
• Study First Submitted: 2022-02-10
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-01
• Last Update Submitted: 2022-03-01
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Students were eligible to participate in this study if they:

1. 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;
2. Accepted participation in the study, including willingness to abide by the randomization process, by signing student assent on the consent form;
3. 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:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Paced Breathing	Slow diaphragmatic breathing	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.
Guide-Paced Breathing	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.

Primary Outcome Measures

Name	Time	Method
Feasibility - compliance with effectiveness assessments	7.5 weeks	Number of participants completing the STAI and CO2TT assessments
Feasibility - effectiveness assessments ease and tolerability	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.
Feasibility - compliance with breathing curriculum	5 weeks	Number of participants completing the breathing practices
Feasibility - curriculum ease and tolerability	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.

Trial Locations

Locations (1)

Aspen High School; 🇺🇸 Aspen, Colorado, United States