- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05266833
Breathing for Adolescent Stress Reduction Feasibility RCT
Slow-Breathing Curriculum for Stress Reduction in High School Students: A Feasibility Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Colorado
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Aspen, Colorado, United States, 81611
- Aspen High School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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.
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|
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Experimental: Self-Paced 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.
|
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. |
|
Experimental: Guide-Paced 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - compliance with breathing curriculum
Time Frame: 5 weeks
|
Number of participants completing the breathing practices
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5 weeks
|
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Feasibility - compliance with effectiveness assessments
Time Frame: 7.5 weeks
|
Number of participants completing the STAI and CO2TT assessments
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7.5 weeks
|
|
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.
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1-week followup period
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Feasibility - effectiveness assessments ease and tolerability
Time Frame: 1-week followup period
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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.
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1-week followup period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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5 weeks
|
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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.
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1.5-week baseline period and 1-week followup period
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Collaborators and Investigators
Investigators
- Principal Investigator: Tanya GK Bentley, PhD, Health and Human Performance Foundation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 101 (Other Identifier: Hamilton Integrated Research Ethics Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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