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临床试验/NCT07055061
NCT07055061招募中不适用

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

Shanghai Mental Health Center3 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
3
主要终点
Occupational Stress

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: ISO Principle Music Intervention (Behavioral)

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.

干预措施: DUL Principle Music Intervention (Behavioral)

ISO Group with Waiting-list

Active Comparator

Participants in this group will receive the same intervention of ISO group after 5 days' waiting.

干预措施: ISO Principle Music Intervention with Waiting-list (Behavioral)

DUL Group with Waiting-list

Active Comparator

Participants in this group will receive the same intervention of DUL group after 5 days' waiting.

干预措施: DUL Principle Music Intervention with Waiting-list (Behavioral)

结局指标

主要结局

Occupational Stress

时间窗: Baseline, pre-intervention, Day1; Post-intervention, Day 6; 1 week post-intervention, Day 13; 1 month post-intervention, Day 36.

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

时间窗: Baseline, pre-intervention, Day1; Post-intervention, Day 6; 1 week post-intervention, Day 13; 1 month post-intervention, Day 36.

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

时间窗: Baseline, pre-intervention, Day1; Post-intervention, Day 6; 1 week post-intervention, Day 13; 1 month post-intervention, Day 36.

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.

Occupational Stress

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • State Anxiety(Before and immediately after each intervention session (twice per day of Day 2 to 6))
  • Perceived Stress(Before and immediately after each intervention session (twice per day of Day 2 to 6))
  • Valence, Arousal, and Dominance(Before and immediately after each music piece (9 times per day of Day 2 to 6))
  • Perceived Stress(Before and immediately after each intervention session (twice per day of Day 2 to 6))
  • Valence, Arousal, and Dominance(Before and immediately after each music piece (9 times per day of Day 2 to 6))
  • Perceived Anxiety(Before and immediately after each intervention session (twice per day from Day 2 to Day 6))
  • Perceived Depression(Before and immediately after each intervention session (twice per day from Day 2 to Day 6))
  • Acceptability and Engagement(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yue DING

Associate Research Fellow

Shanghai Mental Health Center

研究点 (3)

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