Breathing for Adolescent Stress Reduction Feasibility RCT

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266833
• Other study ID #: 101
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: March 29, 2021

Study information

• Verified date: March 2022
• Source: Health and Human Performance Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 29, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Respiratory Aspiration
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Aspen High School	Aspen	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Health and Human Performance Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - compliance with breathing curriculum	Number of participants completing the breathing practices	5 weeks
Primary	Feasibility - compliance with effectiveness assessments	Number of participants completing the STAI and CO2TT assessments	7.5 weeks
Primary	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
Primary	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	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.	5 weeks
Secondary	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.	1.5-week baseline period and 1-week followup period