AnxietyNCT05266833
Breathing for Adolescent Stress Reduction Feasibility RCT
A study testing Slow diaphragmatic breathing in people with Anxiety and Stress, run by Health and Human Performance Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- What is being tested?
- Slow diaphragmatic breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 29 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Slow-Breathing Curriculum for Stress Reduction in High School Students: A Feasibility Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Slow diaphragmatic breathing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow diaphragmatic breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Self-Paced Breathing | Experimental | 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. Receives: Behavioral: Slow diaphragmatic breathing |
| Guide-Paced Breathing | Experimental | 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. Receives: Behavioral: Slow diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - compliance with breathing curriculum
Number of participants completing the breathing practices
Measured: 5 weeks
Feasibility - compliance with effectiveness assessments
Number of participants completing the STAI and CO2TT assessments
Measured: 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.
Measured: 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.
Measured: 1-week followup period
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1.5-week baseline period and 1-week followup period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start20 Jan 2021
- Primary completion2 Feb 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health and Human Performance Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya GK Bentley, PhD, Principal investigator, Health and Human Performance Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266833
- Sponsor's protocol ID
- 101
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36189008
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow-Breathing Curriculum for Stress Reduction in High School Students: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05266833
- Acronym / sponsor ID
- 101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Health and Human Performance FoundationUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Self-Paced Breathing | Experimental | Behavioral: Slow diaphragmatic breathingThe 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 | Experimental | Behavioral: Slow diaphragmatic breathingThe 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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow diaphragmatic breathingThe 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. | Behavioural | Guide-Paced Breathing, Self-Paced Breathing |
Primary outcome
Feasibility - compliance with breathing curriculum
Time frame: 5 weeks
Number of participants completing the breathing practices
Feasibility - compliance with effectiveness assessments
Time frame: 7.5 weeks
Number of participants completing the STAI and CO2TT assessments
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.
Feasibility - effectiveness assessments ease and tolerability
Time frame: 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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 36189008Bentley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya GK Bentley, PhD principal investigator
Health and Human Performance Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow diaphragmatic breathing in people with Anxiety and Stress, run by Health and Human Performance Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - compliance with breathing curriculum (time frame: 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05266833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.