AI-Guided Stress Management Breathing Practices Via a Wearable Device

March 11, 2025 updated by: Yinyin Zang, PhD, Peking University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100871
        • Peking University
        • Contact:
        • Contact:
          • Yinyin Zang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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. Plan is adjusted weekly based on participant's feedback.
Active Comparator: Control group
Behavioral: Progressive muscle relaxation
Participant practices progressive muscle relaxation for 5 minutes daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress
Time Frame: baseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks
The investigators will explore the effectiveness of the AI-guided breathing practices on stress management using a self-developed stress questionnaire. The questionnaire consists of 15 items, each rated on a 5-point scale, with higher scores indicating greater perceived stress.
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
The investigators will explore the effectiveness of the AI-guided breathing practices on emotion using the positive and negative affect schedule(PANAS). The questionnaire consists of 20 items, each rated on a 5-point scale, with higher scores on the negative affect subscale indicating greater negative emotion, and higher scores on the positive affect subscale indicating greater positive emotion.
baseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks
The investigators will explore the effectiveness of the AI-guided breathing practices on enhancing sleep quality using the insomnia severity index(ISI). The questionnaire consists of 7 items, each rated on a 5-point scale, with higher scores indicating worse sleep quality.
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
The investigators will explore the effectiveness of the AI-guided breathing practices on reducing alexithymia using a self-developed alexithymia questionnaire. The questionnaire consists of 23 items, each rated on a 5-point scale, with higher scores indicating greater alexithymia.
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
The investigators will explore the effectiveness of the AI-guided breathing practices on reducing irritation using a self-developed irritation questionnaire. The questionnaire consists of 18 items, each rated on a 5-point scale, with higher scores indicating greater irritation.
baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-Guided Breathing Practices

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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