Clinical trial NCT05266833: Breathing for Adolescent Stress Reduction Feasibility RCT
Official title: Slow-Breathing Curriculum for Stress Reduction in High School Students: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Lead sponsor: Health and Human Performance Foundation
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 43
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility - compliance with breathing curriculum
timeFrame: 5 weeks
measure: Feasibility - compliance with effectiveness assessments
timeFrame: 7.5 weeks
measure: Feasibility - curriculum ease and tolerability
timeFrame: 1-week followup period
measure: Feasibility - effectiveness assessments ease and tolerability
timeFrame: 1-week followup period
Secondary outcomes:
measure: 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.
timeFrame: 5 weeks
measure: 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.
timeFrame: 1.5-week baseline period and 1-week followup period
Other outcomes:
Locations:
city: Aspen
country: United States
facility: Aspen High School
state: Colorado
Study officials:
affiliation: Health and Human Performance Foundation
name: Tanya GK Bentley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.