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NCT Number: NCT07055061

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Department of Psychology of Tsinghua University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Occupational Stress

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

    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.

  2. Anxiety

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

    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.

  3. Depression

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

    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.

Secondary outcomes

  1. Perceived Stress

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

    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.

  2. Perceived Anxiety

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

    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.

  3. Perceived Depression

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

    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.

  4. Valence, Arousal, and Dominance

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

    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.

  5. Acceptability and Engagement

    Time frame: 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

    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.

Other outcomes

  1. EMA RDoC

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

    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.

  2. EMA Emotional Symptoms

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

    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.

  3. EMA Work Stress

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Zhang

CONTACT

[email protected]

8613810433221

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • Tsinghua University

Registry information

Acronym: ISO4SAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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