An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression

NCT07055061 | Recruiting

• 2 other identifiers: THU042025100262101324
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effectiveness of a music-based intervention, guided by the ISO principle, in reducing stress, anxiety and depression induced by work, family or others among adults. The ISO principle suggests that emotional regulation can be supported by gradually modifying the emotional characteristics of music to help individuals transition to a desired emotional state. Participants in this study will be randomly assigned to either a music intervention group or a control group. The intervention group will receive personalized music playlists designed to help reduce stress, anxiety and depression. The control group will not receive any music intervention during the same period. Outcomes will be measured using self-report questionnaires assessing stress, emotional state, and well-being. The study is designed to contribute to the development of accessible, non-invasive stress management tools using music as a behavioral intervention.

Conditions

Stress; Anxiety; Depression in Adults

Keywords

music intervention; emotion regulation; ISO principle

Outcome Measures

Primary Outcomes (3)

• Occupational Stress

  Measured by the Occupational Stress Inventory Revised - Personal Strain Questionnaire (OSIR-PSQ). Participants complete the questionnaire at baseline and post-intervention to assess levels of personal strain related to work stress. The total scores range from 40 to 200, with higher scores indicating greater occupational stress.

  Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.

• Anxiety

  Assessed using the Self-Rating Anxiety Scale (SAS). Measures general anxiety symptoms before and after the intervention. The total scores range from 20 to 80, with higher scores indicating greater anxiety severity.

  Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.

• Depression

  Assessed using the Self-Rating Depression Scale (SDS). Evaluates depressive symptoms at baseline and post-intervention. The total scores range from 20 to 80, with higher scores indicating greater depression severity.

  Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.

Secondary Outcomes (5)

• Perceived Stress

  Before and immediately after each intervention session (twice per day of Day 2 to 6)

• Perceived Anxiety

  Before and immediately after each intervention session (twice per day from Day 2 to Day 6)

• Perceived Depression

  Before and immediately after each intervention session (twice per day from Day 2 to Day 6)

• Valence, Arousal, and Dominance

  Before and immediately after each music piece (9 times per day of Day 2 to 6)

• Acceptability and Engagement

  Once daily after each music listening session from Day 2 to Day 6 for Engagement and Once on Day 6 after the music intervention for Acceptability

Other Outcomes (3)

• EMA RDoC

  Four times daily (before intervention session) from Day 2 to Day 6

• EMA Emotional Symptoms

  Four times daily (before intervention session) from Day 2 to Day 6

• EMA Work Stress

  Four times daily (before intervention session) from Day 2 to Day 6

Study Arms (4)

ISO Group

EXPERIMENTAL

Participants in this group will receive a music intervention based on the ISO principle. The playlists are designed to gradually shift emotional states by starting with music that matches the participant's current mood and progressing toward tracks that reflect the desired emotional state, aiming to promote stress reduction and emotional regulation.

Behavioral: ISO Principle Music Intervention

DUL Group

ACTIVE COMPARATOR

Participants in this group will receive a music intervention based on the direct-up-lifting (DUL) principle. The playlists directly contrast the participant's current emotional state by immediately introducing music that represents the target mood (e.g., relaxing music for a stressed state), with the aim of counteracting stress and promoting emotional change.

Behavioral: DUL Principle Music Intervention

ISO Group with Waiting-list

ACTIVE COMPARATOR

Participants in this group will receive the same intervention of ISO group after 5 days' waiting.

Behavioral: ISO Principle Music Intervention with Waiting-list

DUL Group with Waiting-list

ACTIVE COMPARATOR

Participants in this group will receive the same intervention of DUL group after 5 days' waiting.

Behavioral: DUL Principle Music Intervention with Waiting-list

Interventions

DUL Principle Music Intervention BEHAVIORAL

Participants will receive music playlists based on the compensation principle, where the music contrasts the participant's current emotional state by directly presenting tracks aligned with the desired emotional outcome (e.g., calm music for stressed mood). This approach seeks to counteract stress and shift affective states through musical contrast.

DUL Group

ISO Principle Music Intervention with Waiting-list BEHAVIORAL

Participants will receive music playlists designed according to the IS0 principle, which involves matching the participant's current emotional state and gradually transitioning to music reflecting a desired mood. The intervention aims to reduce stress and support emotional regulation by guiding affective resonance through music progression. The intervention will be delivered to participants after 5 day's waiting.

ISO Group with Waiting-list

DUL Principle Music Intervention with Waiting-list BEHAVIORAL

Participants will receive music playlists based on the compensation principle, where the music contrasts the participant's current emotional state by directly presenting tracks aligned with the desired emotional outcome (e.g., calm music for stressed mood). This approach seeks to counteract stress and shift affective states through musical contrast. The intervention will be delivered to participants after 5 days' waiting.

DUL Group with Waiting-list

ISO Principle Music Intervention BEHAVIORAL

Participants will receive music playlists designed according to the ISO principle, which involves matching the participant's current emotional state and gradually transitioning to music reflecting a desired mood. The intervention aims to reduce stress and support emotional regulation by guiding affective resonance through music progression.

ISO Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Minimum of a secondary specialized school degree (vocational college) or higher

You may not qualify if:

• Self-reported current or recent use of medication or history of surgical treatment
• Self-reported history of psychiatric disorders
• Self-reported hearing impairments
• Female participants who are self-reported currently pregnant or breastfeeding

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Tsinghua University: collaborator

Study Sites (2)

The Department of Psychology of Tsinghua University

Beijing, Beijing Municipality, 100084, China

COMPLETED

Tsinghua University

Beijing, Beijing Municipality, 100084, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Central Study Contacts

Dan Zhang

CONTACT

8613810433221; dzhang@tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Fellow

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start: April 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (2)