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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07055061
Acronym
ISO4SAD
Enrollment
2000
Registered
2025-07-08
Start date
2024-04-23
Completion date
2026-12-31
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression in Adults, Stress

Keywords

music intervention, emotion regulation, ISO principle

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.

Interventions

BEHAVIORALISO 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.

BEHAVIORALDUL 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.

BEHAVIORALISO 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.

BEHAVIORALDUL 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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER
Tsinghua University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Occupational StressBaseline, 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.
AnxietyBaseline, 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.
DepressionBaseline, 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

MeasureTime frameDescription
Perceived StressBefore 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.
Perceived AnxietyBefore 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.
Perceived DepressionBefore 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.
Valence, Arousal, and DominanceBefore 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.
Acceptability and EngagementOnce daily after each music listening session from Day 2 to Day 6 for Engagement and Once on Day 6 after the music intervention for AcceptabilityAn 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.

Countries

China

Contacts

CONTACTDan Zhang
dzhang@tsinghua.edu.cn8613810433221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026