SKY Breath Intervention / Anxiety Disorders / Depression · Observational Study

SKY Breath Intervention

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a terminated observational study registration for a planned 8-week SKY breath intervention in adolescents with depression and anxiety. No outcome data are reported in this registry record; the study enrolled 14 of 60 planned participants before termination and remains a preliminary feasibility effort.

What was studied

Observational. Depression, Anxiety Disorders; age from 16 Years; to 24 Years; accepts healthy volunteers. Intervention: Healthy controls; Depressed adolescents. n = 14. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This terminated study does not yet provide evidence on SKY breath intervention efficacy in adolescent depression. Clinicians should not interpret this registry record as establishing benefit; results would be needed to inform practice.

Plain-language summary

This is a terminated observational registry record with 14 actual enrollees (versus 60 planned), reporting no results; it describes a feasibility study of a behavioral intervention in adolescent depression with design and outcome measures but no outcome data.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Mean Change in Depression Scores on the Beck Depression Inventory-II (BDI-II) (assessed at Baseline and 1month, Baseline and 2 months); Mean Change in Depression Scores on the Generalized Anxiety Disorder-7. (assessed at Baseline and 1month, Baseline and 2 months)

DesignObservational

PopulationDepression, Anxiety Disorders; age from 16 Years; to 24 Years; accepts healthy volunteers

Sample size14

InterventionHealthy controls; Depressed adolescents

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Actual enrollment14

Primary outcome measure 1Mean Change in Depression Scores on the Beck Depression Inventory-II (BDI-II)

Primary outcome measure 2Mean Change in Depression Scores on the Generalized Anxiety Disorder-7

Intervention duration8 weeks

Assessment timepointsBaseline, 4 weeks, post-intervention

Clinical bottom line

Caveats

Study terminated before completion; no outcome data reported in this registry record.
Actual enrollment (14) fell far short of planned sample (60); sample size inadequate for statistical power.
Observational design without control arm comparison specified in registry.
Neuroimaging and salivary cortisol endpoints mentioned but no results posted; cannot assess mechanistic findings.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational design with no control arm specified in registry.

Directness

moderate

Directly targets adolescent depression and anxiety using clinical outcome measures.

Consistency

insufficient

No results reported; cannot assess consistency with prior evidence.

Risk of bias

insufficient

Registry record does not describe allocation, blinding, or outcome ascertainment.

Sample adequacy

limited

14 actual enrollees versus 60 planned; study terminated early with underpowered sample.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05388110). This is a study registration, not published results. Lead sponsor: University of California, San Francisco. Recruitment status: TERMINATED. Study type: OBSERVATIONAL. Enrollment: 14 participants (ACTUAL). Conditions: Depression, Anxiety Disorders. Interventions: BEHAVIORAL: SKY Breath Intervention. Primary outcome measures: Mean Change in Depression Scores on the Beck Depression Inventory-II (BDI-II) , Baseline and 1month, Baseline and 2 months; Mean Change in Depression Scores on the Generalized Anxiety Disorder-7. , Baseline and 1month, Baseline and 2 months. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of California, San FrancisSKY Breath InterventionAnxiety DisordersDepressionNCT05388110