SKY Breath Intervention

NCT05388110 | Active Not Recruiting DMC

• 1 other identifier: 21-33230
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 1month, Baseline and 2 months

Secondary Outcomes (3)

• Mean Change in Reynolds Adolescent Depression Scale (RADS-2)

  Baseline and 1month, Baseline and 2 months

• Mean Change in Multidimensional Anxiety Scale for Children (MASC-2)

  Baseline and 1month, Baseline and 2 months

• Mean Change in Hamiliton Anxiety Scale (HAM-A)

  Baseline and 1month, Baseline and 2 months

Study Arms (2)

Healthy controls

Behavioral: SKY Breath Intervention

Depressed adolescents

Behavioral: SKY Breath Intervention

Interventions

SKY Breath Intervention BEHAVIORAL

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.

Depressed adolescents; Healthy controls

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Depressed adolescents and healthy controls ages 16-24 years old

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Passive drool/saliva will be collected.

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Yan Li, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 24, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)