StressISO4SADNCT07055061
An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression
A study testing ISO Principle Music Intervention, DUL Principle Music Intervention and ISO Principle Music Intervention with Waiting-list in people with Stress and Anxiety, run by Shanghai Mental Health Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression in Adults
- What is being tested?
- ISO Principle Music Intervention, DUL Principle Music Intervention and ISO Principle Music Intervention with Waiting-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 23 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum of a secondary specialized school degree (vocational college) or higher
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Completed
The Department of Psychology of Tsinghua University
Beijing, Beijing Municipality, 100084
- Recruiting
Tsinghua University
Beijing, Beijing Municipality, 100084
Dan Zhang, 8613810433221, dzhang@tsinghua.edu.cn
About this study
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
- Being tested
- ISO Principle Music Intervention, DUL Principle Music Intervention, ISO Principle Music Intervention with Waiting-list, DUL Principle Music Intervention with Waiting-list
- Keywords
- music intervention, emotion regulation, ISO principle
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISO Principle Music InterventionBehavioural
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 InterventionBehavioural
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-listBehavioural
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-listBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: DUL Principle Music Intervention with Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Before and immediately after each intervention session (twice 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.
Measured: 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.
Measured: Before and immediately after each intervention session (twice per day from Day 2 to Day 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.
Measured: Before and immediately after each music piece (9 times per day of Day 2 to 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start23 Apr 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Principal investigator, Yue DING, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055061
- Sponsor's protocol ID
- THU0420251002
- Other IDs
- 62101324
- Acronym
- ISO4SAD
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time. A plan for data sharing will be developed prior to study completion.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression
- ClinicalTrials.gov ID
- NCT07055061
- Acronym / sponsor ID
- ISO4SAD / THU0420251002
- Conditions
- Stress, Anxiety, Depression in Adults
- Keywords
- music intervention, emotion regulation, ISO principle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ISO Group | Experimental | Behavioral: ISO Principle Music InterventionParticipants 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. |
| DUL Group | Active comparator | Behavioral: DUL Principle Music InterventionParticipants 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. |
| ISO Group with Waiting-list | Active comparator | Behavioral: ISO Principle Music Intervention with Waiting-listParticipants in this group will receive the same intervention of ISO group after 5 days' waiting. |
| DUL Group with Waiting-list | Active comparator | Behavioral: DUL Principle Music Intervention with Waiting-listParticipants in this group will receive the same intervention of DUL group after 5 days' waiting. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Minimum of a secondary specialized school degree (vocational college) or higher
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISO Principle Music InterventionParticipants 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. | Behavioural | ISO Group |
| DUL Principle Music InterventionParticipants 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. | Behavioural | DUL Group |
| ISO Principle Music Intervention with Waiting-listParticipants 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. | Behavioural | ISO Group with Waiting-list |
| DUL Principle Music Intervention with Waiting-listParticipants 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. | Behavioural | DUL Group with Waiting-list |
Primary outcome
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.
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.
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.
5 secondary outcomes
Perceived Stress
Time frame: Before and immediately after each intervention session (twice per day of Day 2 to 6)
Perceived Anxiety
Time frame: Before and immediately after each intervention session (twice per day from Day 2 to Day 6)
Perceived Depression
Time frame: Before and immediately after each intervention session (twice per day from Day 2 to Day 6)
Valence, Arousal, and Dominance
Time frame: Before and immediately after each music piece (9 times per day of Day 2 to 6)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided. Undecided at this time. A plan for data sharing will be developed prior to study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISO Principle Music Intervention, DUL Principle Music Intervention and ISO Principle Music Intervention with Waiting-list in people with Stress and Anxiety, run by Shanghai Mental Health Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Zhang (8613810433221, dzhang@tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Stress (time frame: Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.