DepressionNCT05388110
SKY Breath Intervention
An observational study of Depression and Anxiety Disorders, run by University of California, San Francisco at 1 site in United States.
Trial summary
Depression is highly debilitating and prevalent among adolescents. Adolescent-onset depression is associated with long, severe, and recurrent episodes that are often not responsive to treatment. There is a dire need to develop novel treatments that are efficient, cost-effective, and tolerant for this population. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- SKY Breath Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 31 Dec 2023
- Phase
- Observational
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Depressed adolescents and healthy controls ages 16-24 years old
Who may be able to join
- adolescent participants ages 16-24 yrs old (NIH defines adolescents as up through age 24 years old)
- mild-to-moderate depression with the BDI-II score greater than or equal to 14 (Smarr and Keefer 2011)
- technologically able (Zoom);
- nonpractitioners of daily meditation/breath-work.
Who cannot join
- pregnant or lactating females
- metal implants unsafe for MRI
- current or lifetime diagnosis of schizophrenia, schizoaffective, bipolar on lithium, or seizure disorders
- recent surgical patient (within 6 months)
- substance use disorder within the last 1 year
- history of significant medical conditions (e.g. traumatic brain injury)
- suicidal ideation (SI) with intent and/or plan to harm self (SI without intent and/or plan to harm self will be allowed to enter the study)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Neurobiological Mechanism of SKY Breath Intervention
Depression is highly debilitating and prevalent among adolescents. Adolescent-onset depression is associated with long, severe, and recurrent episodes that are often not responsive to treatment. There is a dire need to develop novel treatments that are efficient, cost-effective, and tolerant for this population. Sudarshan Kriya Yoga (SKY) is a breath-based meditative practice that entails a sequence of specific breathing techniques to help practitioners achieve a state of calm alertness. It has offered benefits as a therapeutic option for mild-to-moderate depression and anxiety disorders and as an adjunctive treatment in patients with major depressive disorder, but the neurological mechanism of SKY breath intervention is still not fully understood.
The goal of this study is to determine the efficacy of SKY breath intervention in treating depressed adolescents and to understand its mechanisms. In this study, thirty depressed adolescents and thirty healthy controls will be recruited to evaluate the efficacy of the 8-week SKY intervention. Assessment for depression and anxiety, salivary cortisol, resting heart rate, blood pressure, and neuroimaging will be collected at the baseline, 4 weeks into SKY intervention (questionnaires only), and post-intervention.
This will be the first study to evaluate the potential benefits of of SKY breath intervention as a treatment option for depressed adolescents.
Read the detailed description
Participants \& Screening: All participants (16-24yrs) will be first screened for COVID and only those who are negative will be allowed to enroll. Participants who meet the criteria for the study at initial online screening will complete measures with study investigator including relevant demographics information and the BDI-II.
SKY Intervention: The SKY breath intervention will take place online via Zoom over 6 consecutive days for 3 hours each day as part of the Campus SKY Breath Meditation workshop.
Weekly intervention follow-ups: After completion of the 6-day online workshop, participants will be encouraged to continue a home-based practice (25 minutes per day, daily records is needed for reimbursement) and required to attend 1-hour weekly (online) follow-ups for 8 weeks during which there will be group practice of the workshop material. Attendance is mandatory for all follow-ups. Given the popularity of the program, participation is typically high. Instructor will verify attendance and ensure that all participants are proficient in performing SKY. The effectiveness of SKY and staying on track with study procedures are facilitated by subjects, therefore, the study consent will ask subjects if they are willing to share their email/phone with others in the study.
Cortisol Levels and Resting Heart Rate: During each MRI visit, saliva cortisol, blood pressure, and resting heart rate will be measured in participants. Passive drool/ saliva will be collected. Following this, subjects will do belly breathing exercise for 3-5 mins. Subjects will sit in a chair, and place one hand on the upper chest and the other hand on the belly. Subjects will be asked to breathe in slowly through the nose so they can feel their stomach rise, then will be asked to exhale slowly through their pursed lips so they can feel the hand on their chest remain relatively still. Saliva will then be collected in a microcentrifuge tube for 2 min and stored in a -80°C freezer in order to assess salivary cortisol levels. For measurement of cortisol, saliva will be assayed using a High-Sensitivity Salivary Cortisol Enzyme Immunoassay Kit from Salimetrics, Inc. Samples will be processed in a standard Bio-safety level 2 laboratory equipped to handle clinical samples with all the appropriate personal protective equipment. Not only is saliva collection less invasive than blood but it is also a routinely established method to assess cortisol.
MR Protocol: The MR experiments will be performed on the GE 7T whole-body scanner in the Surbeck Laboratory using a 32-channel receive-only array with a 2-channel transmit coil. The MR protocol includes structural images, metabolic imaging, structural and functional connectivities.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- SKY Breath Intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY Breath InterventionBehavioural
Sudarshan Kriya Yoga (SKY) is a breath-based meditative practice that entails a sequence of specific breathing techniques to help practitioners achieve a state of calm alertness. It has offered benefits as a therapeutic option for mild-to-moderate depression and anxiety disorders and as an adjunctive treatment in patients with major depressive disorder, but the neurological mechanism of SKY breath intervention is still not fully understood.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Behavioral: SKY Breath Intervention | |
| Depressed adolescents | Not described Receives: Behavioral: SKY Breath Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Depression Scores on the Beck Depression Inventory-II (BDI-II)
The differences at 8-week between intervention and controls in depression and anxiety as measured by the Beck Depression Inventory-II. Twenty-one questions, self reporting with scores ranging from 0 to 63. Higher score indicates more severe depression.
Measured: Baseline and 1month, Baseline and 2 months
Mean Change in Depression Scores on the Generalized Anxiety Disorder-7.
The differences at 8-week between intervention and controls in depression and anxiety as measured by the Generalized Anxiety Disorder-7. Seven questions on a three point scale, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
Measured: Baseline and 1month, Baseline and 2 months
Secondary outcomes (3)
Mean Change in Reynolds Adolescent Depression Scale (RADS-2)
Thirty questions, self-report measures the four basic dimensions of depression: Dysphoric Mood, Anhedonia/Negative Affect, Negative Self-Evaluation, and Somatic Complaints. Identifies depressive symptoms in adolescents, provide an indication of the clinical severity of the individual's depressive symptoms (normal, mild, moderate or severe).
Measured: Baseline and 1month, Baseline and 2 months
Mean Change in Multidimensional Anxiety Scale for Children (MASC-2)
MASC-2 is a self reporting questionnaire with fifty questions that assesses the presence of symptoms related to anxiety disorders in youth. Responses on the MASC 2 are combined to create 11 T-scores: MASC 2 Total Score, Separation Anxiety/Phobias, Generalized Anxiety Disorder (GAD) Index, Social Anxiety (Total, Humiliation/Rejection, Performance Fears), Obsessions \& Compulsions, Physical Symptoms (Total, Tense/Restless, Panic), and Harm Avoidance. Higher T-scores indicate more severe and/or a greater number of symptoms.
Measured: Baseline and 1month, Baseline and 2 months
Mean Change in Hamiliton Anxiety Scale (HAM-A)
HAM-A is a fourteen item questionnaire that measure the severity of anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: Baseline and 1month, Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start22 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: The study was terminated due to limited resources and the loss of key study personnel, which made completion of the planned enrollment infeasible. The decision was not based on safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Li, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388110
- Sponsor's protocol ID
- 21-33230
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Mechanism of SKY Breath Intervention
- ClinicalTrials.gov ID
- NCT05388110
- Acronym / sponsor ID
- 21-33230
- Conditions
- Depression, Anxiety Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to limited resources and the loss of key study personnel, which made completion of the planned enrollment infeasible. The decision was not based on safety or efficacy concerns.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 May 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.
Depression is highly debilitating and prevalent among adolescents. Adolescent-onset depression is associated with long, severe, and recurrent episodes that are often not responsive to treatment. There is a dire need to develop novel treatments that are efficient, cost-effective, and tolerant for this population. Sudarshan Kriya Yoga (SKY) is a breath-based meditative practice that entails a sequence of specific breathing techniques to help practitioners achieve a state of calm alertness. It has offered benefits as a therapeutic option for mild-to-moderate depression and anxiety disorders and as an adjunctive treatment in patients with major depressive disorder, but the neurological mechanism of SKY breath intervention is still not fully understood.
The goal of this study is to determine the efficacy of SKY breath intervention in treating depressed adolescents and to understand its mechanisms. In this study, thirty depressed adolescents and thirty healthy controls will be recruited to evaluate the efficacy of the 8-week SKY intervention. Assessment for depression and anxiety, salivary cortisol, resting heart rate, blood pressure, and neuroimaging will be collected at the baseline, 4 weeks into SKY intervention (questionnaires only), and post-intervention.
This will be the first study to evaluate the potential benefits of of SKY breath intervention as a treatment option for depressed adolescents.
Detailed description
Participants \& Screening: All participants (16-24yrs) will be first screened for COVID and only those who are negative will be allowed to enroll. Participants who meet the criteria for the study at initial online screening will complete measures with study investigator including relevant demographics information and the BDI-II.
SKY Intervention: The SKY breath intervention will take place online via Zoom over 6 consecutive days for 3 hours each day as part of the Campus SKY Breath Meditation workshop.
Weekly intervention follow-ups: After completion of the 6-day online workshop, participants will be encouraged to continue a home-based practice (25 minutes per day, daily records is needed for reimbursement) and required to attend 1-hour weekly (online) follow-ups for 8 weeks during which there will be group practice of the workshop material. Attendance is mandatory for all follow-ups. Given the popularity of the program, participation is typically high. Instructor will verify attendance and ensure that all participants are proficient in performing SKY. The effectiveness of SKY and staying on track with study procedures are facilitated by subjects, therefore, the study consent will ask subjects if they are willing to share their email/phone with others in the study.
Cortisol Levels and Resting Heart Rate: During each MRI visit, saliva cortisol, blood pressure, and resting heart rate will be measured in participants. Passive drool/ saliva will be collected. Following this, subjects will do belly breathing exercise for 3-5 mins. Subjects will sit in a chair, and place one hand on the upper chest and the other hand on the belly. Subjects will be asked to breathe in slowly through the nose so they can feel their stomach rise, then will be asked to exhale slowly through their pursed lips so they can feel the hand on their chest remain relatively still. Saliva will then be collected in a microcentrifuge tube for 2 min and stored in a -80°C freezer in order to assess salivary cortisol levels. For measurement of cortisol, saliva will be assayed using a High-Sensitivity Salivary Cortisol Enzyme Immunoassay Kit from Salimetrics, Inc. Samples will be processed in a standard Bio-safety level 2 laboratory equipped to handle clinical samples with all the appropriate personal protective equipment. Not only is saliva collection less invasive than blood but it is also a routinely established method to assess cortisol.
MR Protocol: The MR experiments will be performed on the GE 7T whole-body scanner in the Surbeck Laboratory using a 32-channel receive-only array with a 2-channel transmit coil. The MR protocol includes structural images, metabolic imaging, structural and functional connectivities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Behavioral: SKY Breath Intervention |
| Depressed adolescents | – | Behavioral: SKY Breath Intervention |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Depressed adolescents and healthy controls ages 16-24 years old
Key inclusion criteria (4 listed)
- adolescent participants ages 16-24 yrs old (NIH defines adolescents as up through age 24 years old)
- mild-to-moderate depression with the BDI-II score greater than or equal to 14 (Smarr and Keefer 2011)
- technologically able (Zoom);
- nonpractitioners of daily meditation/breath-work.
Key exclusion criteria (7 listed)
- pregnant or lactating females
- metal implants unsafe for MRI
- current or lifetime diagnosis of schizophrenia, schizoaffective, bipolar on lithium, or seizure disorders
- recent surgical patient (within 6 months)
- substance use disorder within the last 1 year
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 |
|---|---|---|
| SKY Breath InterventionSudarshan Kriya Yoga (SKY) is a breath-based meditative practice that entails a sequence of specific breathing techniques to help practitioners achieve a state of calm alertness. It has offered benefits as a therapeutic option for mild-to-moderate depression and anxiety disorders and as an adjunctive treatment in patients with major depressive disorder, but the neurological mechanism of SKY breath intervention is still not fully understood. | Behavioural | Depressed adolescents, Healthy controls |
Primary outcome
Mean Change in Depression Scores on the Beck Depression Inventory-II (BDI-II)
Time frame: Baseline and 1month, Baseline and 2 months
The differences at 8-week between intervention and controls in depression and anxiety as measured by the Beck Depression Inventory-II. Twenty-one questions, self reporting with scores ranging from 0 to 63. Higher score indicates more severe depression.
Mean Change in Depression Scores on the Generalized Anxiety Disorder-7.
Time frame: Baseline and 1month, Baseline and 2 months
The differences at 8-week between intervention and controls in depression and anxiety as measured by the Generalized Anxiety Disorder-7. Seven questions on a three point scale, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
3 secondary outcomes
Mean Change in Reynolds Adolescent Depression Scale (RADS-2)
Time frame: Baseline and 1month, Baseline and 2 months
Mean Change in Multidimensional Anxiety Scale for Children (MASC-2)
Time frame: Baseline and 1month, Baseline and 2 months
Mean Change in Hamiliton Anxiety Scale (HAM-A)
Time frame: Baseline and 1month, Baseline and 2 months
Results and safety
The study was stopped early (reason given: The study was terminated due to limited resources and the loss of key study personnel, which made completion of the planned enrollment infeasible. The decision was not based on safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Yan Li, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety Disorders, run by University of California, San Francisco 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?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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: stopped early, as of the sponsor's last update on 11 Aug 2026. 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 was stopped early (reason given: The study was terminated due to limited resources and the loss of key study personnel, which made completion of the planned enrollment infeasible. The decision was not based on safety or efficacy concerns.). Results are not available in the source record.
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?
Mean Change in Depression Scores on the Beck Depression Inventory-II (BDI-II) (time frame: Baseline and 1month, Baseline and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.