NCT06881875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 18, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

March 7, 2025

Last Update Submit

March 11, 2025

Conditions

Stress Reduction

Keywords

stress reductionbreathing practiceswearable deviceAI guided intervention

Outcome Measures

Primary Outcomes (2)

  • Perceived stress

    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

    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 Outcomes (3)

  • Sleep quality

    baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

  • Alexithymia

    baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

  • Irritation

    baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: AI-guided breathing practices

Control group

ACTIVE COMPARATOR
Behavioral: Progressive muscle relaxation

Interventions

AI-guided breathing practicesBEHAVIORAL

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 group
Progressive muscle relaxationBEHAVIORAL

Participant practices progressive muscle relaxation for 5 minutes daily.

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 18, 2025

Study Start

March 15, 2025

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

March 18, 2025

Record last verified: 2025-02

Locations

CN(1)