Menu
Not yet recruiting NCT06881875

AI-Guided Stress Management Breathing Practices Via a Wearable Device

No phase Interventional Stress Reduction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-guided breathing practices, Progressive muscle relaxation.
Who it may be relevant to
Registry conditions: Stress Reduction. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

AI-Guided Stress Management Breathing Practices Using a Wearable Device: A Randomized Controlled Trial

Overview

This study explores the effectiveness of AI-guided breathing practices for stress management in adults. In this randomized controlled trial, 120 participants will be recruited and assigned to an intervention group (n=90) or a control group (n=30). The study includes four brief breathing practices, guided by a wristband. The intervention group will interact with an AI chatbot to receive a personalized daily breathing plan for 28 days, adjusted weekly based on feedback. Meanwhile, the control group will practice progressive muscle relaxation daily. It is hypothesized that, the intervention group will have significantly improvements in stress management and emotion regulation skills compare to the control group. These group differences are expected to persist at 1-month, 3-month and 6-month follow-up assessment.

Interventions

  • Behavioral AI-guided breathing practices
    Participant will obtain a wristband with a built-in breathing practices program when assigned to the intervention group. Four kinds of breathing practices are included, which are bee breathing, diaphragmatic breathing, box breathing and 4-7-8 breathing. A specially prompted AI chat bot interviews the participant and designs a personalized daily breathing practice plan according to participant's preference and daily stress. Participant follows the plan in the following 28-day intervention period.
  • Behavioral Progressive muscle relaxation
    Participant practices progressive muscle relaxation for 5 minutes daily.

Primary outcome measures

  • Perceived stress [Time frame: baseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks]
  • Emotion [Time frame: baseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks]
Secondary outcome measures (3)
  • Sleep quality [Time frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks]
  • Alexithymia [Time frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks]
  • Irritation [Time frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks]

Eligibility criteria

Inclusion criteria

  • Currently enrolled college students.
  • Aged between 18 and 30 years old.

Exclusion criteria

  • Current or past history of psychotic disorders.
  • Using contraceptives, cortisol, beta-blockers, antidepressants, or other psychiatric medications, as well as medications for chronic diseases during the intervention and follow-up periods.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University — Beijing

Identifiers

NCT: NCT06881875 · AI-Guided Breathing Practices

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗