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TerminatedNo phase

SKY Breath Intervention

Key facts

Who runs it
University of California, San Francisco
Where
San Francisco, United StatesSee the site
Trial code
Status
Terminated
People taking part
14 people enrolled
Started
22 Apr 2022
Ended
31 Dec 2023
Type of study
Observational, 2 groups
Treatments tested
  • SKY Breath Intervention
Record updated
11 August 2026
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.

Who can take part

Age
16 years to 24 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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 take part

  • metal implants unsafe for MRI
  • recent surgical patient (within 6 months)
  • current or lifetime diagnosis of schizophrenia, schizoaffective, bipolar on lithium, or seizure disorders
  • substance use disorder within the last 1 year
  • history of significant medical conditions (e.g. traumatic brain injury)
  • pregnant or lactating females
  • 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)

Where in United States

  • University of California San FranciscoSan Francisco, United States

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Healthy controls

    Treatment: SKY Breath Intervention

  • Depressed adolescents

    Treatment: SKY Breath Intervention

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neurobiological Mechanism of SKY Breath Intervention
Record updated
11 August 2026