An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
ISO Principle Music Intervention
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
2,000 Participants
are divided into 4 treatment groupsGroup A: ISO GroupExperimental treatment 1 intervention
Group B: DUL GroupActive comparator 1 intervention
Group C: ISO Group with Waiting-listActive comparator 1 intervention
Group D: DUL Group with Waiting-listActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.2
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.
Time frame
Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.3
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.
Time frame
Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.Secondary outcomes
1
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.
Time frame
Before and immediately after each intervention session (twice per day of Day 2 to 6)2
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.
Time frame
Before and immediately after each intervention session (twice per day from Day 2 to Day 6)3
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.
Time frame
Before and immediately after each intervention session (twice per day from Day 2 to Day 6)4
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.
Time frame
Before and immediately after each music piece (9 times per day of Day 2 to 6)Other outcomes
1
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.
Time frame
Four times daily (before intervention session) from Day 2 to Day 62
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.
Time frame
Four times daily (before intervention session) from Day 2 to Day 63
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.
Time frame
Four times daily (before intervention session) from Day 2 to Day 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Mental Health Center
Lead sponsor
Tsinghua University
Collaborator
Source ClinicalTrials.gov