An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression (ISO4SAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Anxiety; Depression in Adults
• Intervention / Treatment: Behavioral: ISO Principle Music Intervention; Behavioral: DUL Principle Music Intervention; Behavioral: ISO Principle Music Intervention with Waiting-list; Behavioral: DUL Principle Music Intervention with Waiting-list

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Zhang; Phone Number: 8613810433221; Email: dzhang@tsinghua.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100084
      • Completed
      • The Department of Psychology of Tsinghua University
    • Beijing, Beijing Municipality, China, 100084
      • Recruiting
      • Tsinghua University
      • Contact: Dan Zhang; Phone Number: 8613810433221; Email: dzhang@tsinghua.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ISO Group; 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; 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.
Active Comparator: DUL Group; 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; 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.
Active Comparator: ISO Group with Waiting-list; Participants in this group will receive the same intervention of ISO group after 5 days' waiting.	Behavioral: ISO Principle Music Intervention with Waiting-list; 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.
Active Comparator: DUL Group with Waiting-list; Participants in this group will receive the same intervention of DUL group after 5 days' waiting.	Behavioral: DUL Principle Music Intervention with Waiting-list; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	Visual Analogue Scale (VAS) used to assess subjective feelings of stress at multiple time points during the study. The score ranges from 1 to 100, with higher score indicating greater subjective stressful feelings.	Before and immediately after each intervention session (twice per day of Day 2 to 6)
Valence, Arousal, and Dominance	Self-Assessment Manikin (SAM) used to measure emotional valence, arousal, and dominance immediately after each music listening session. The score of each dimension ranges from 1 to 9. Higher score of valence indicates more positive emotion. Higher score of arousal indicates greater emotional intensity. Higher score of dominance indicates stronger control of emotion.	Before and immediately after each music piece (9 times per day of Day 2 to 6)
Perceived Anxiety	Visual Analogue Scale (VAS) used to assess subjective feelings of anxiety at multiple time points during the study. The score ranges from 0 to 100, with higher scores indicating greater subjective anxious feelings.	Before and immediately after each intervention session (twice per day from Day 2 to Day 6)
Perceived Depression	Visual Analogue Scale (VAS) used to assess subjective feelings of depression at multiple time points during the study. The score ranges from 0 to 100, with higher scores indicating greater subjective depressive feelings.	Before and immediately after each intervention session (twice per day from Day 2 to Day 6)
Acceptability and Engagement	An acceptability survey used to assess participants' acceptability of questionnaire completion and music listening, and to identify any barriers encountered. The survey is administered once after the completion of the music intervention on Day 6. Acceptability items are rated on a 7-point Likert scale, while barriers are indicated as "Yes" or "No". Engagement assessed after each music intervention session from Day 2 to Day 6. The measure includes a Visual Analogue Scale (VAS) for engagement (0-100) and an open-text item recording whether participants were engaged in other activities simultaneously during music listening.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMA RDoC	Ecological Momentary Assessment (EMA) used to capture psychological states relevant to the Research Domain Criteria (RDoC) before each music listening session. Items are rated on a 7-point Likert scale, assessing domains such as the Negative Valence System (e.g., threat, loss) and the Positive Valence System (e.g., reward responsiveness, approach motivation). Sleep quality is assessed only during the morning measurement, and physical activity is assessed only during the final measurement of the day.	Four times daily (before intervention session) from Day 2 to Day 6
EMA Emotional Symptoms	Ecological Momentary Assessment (EMA) used to monitor transient emotional symptoms before each music listening session. Symptoms include anxiety, sadness, irritability, and anhedonia, each rated on a 7-point Likert scale to reflect momentary severity.	Four times daily (before intervention session) from Day 2 to Day 6
EMA Work Stress	Ecological Momentary Assessment (EMA) used to assess work-related stress before each music listening session. The assessment comprises five Visual Analogue Scale (VAS) items (0-100), measuring workplace tension, sense of control, confidence, irritability, and overall work pressure. Higher scores indicate greater stress or functional impairment.	Four times daily (before intervention session) from Day 2 to Day 6

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Tsinghua University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 12, 2026

Study Registration Dates

• First Submitted: June 26, 2025
• First Submitted That Met QC Criteria: July 3, 2025
• First Posted (Actual): July 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: emotion regulation; music intervention; ISO principle
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Social Behavior; Self-Control; Anxiety Disorders; Emotional Regulation; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: THU0420251002; 62101324 (Other Grant/Funding Number: the National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided at this time. A plan for data sharing will be developed prior to study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No