AI-Guided Stress Management Breathing Practices Via a Wearable Device

NCT ID: NCT06881875

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Stress Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

AI-guided breathing practices

Intervention Type: BEHAVIORAL

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. Plan is adjusted weekly based on participant's feedback.

Control group

Group Type: ACTIVE_COMPARATOR

Progressive muscle relaxation

Intervention Type: BEHAVIORAL

Participant practices progressive muscle relaxation for 5 minutes daily.

Interventions

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. Plan is adjusted weekly based on participant's feedback.

Intervention Type: BEHAVIORAL

Progressive muscle relaxation

Participant practices progressive muscle relaxation for 5 minutes daily.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Currently enrolled college students.

2. Aged between 18 and 30 years old.

Exclusion Criteria

1. Current or past history of psychotic disorders.

2. Using contraceptives, cortisol, beta-blockers, antidepressants, or other psychiatric medications, as well as medications for chronic diseases during the intervention and follow-up periods.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Yinyin Zang, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University

Beijing, Beijing Municipality, China

Countries

China

Facility Contacts

Yinyin Zang, PhD

Role: primary

yinyin.zang@pku.edu.cn

+86-010-62756953

Other Identifiers

AI-Guided Breathing Practices

Identifier Type: -

Identifier Source: org_study_id