Study on Music Intervention of Non-clinical College Students

The purpose of this trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students. The main questions it aims to answer is:

Does the music group effectively intervene in the participants' mental health levels, including indicators such as anxiety and depression?

Participants will:

Attend a music group once a week for 1.5 hours each session, for a total of 6 weeks.

Complete a psychological questionnaire every 3 weeks and a follow-up questionnaire every 2 weeks after the program concludes for twice.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression Anxiety Disorder
• Intervention / Treatment: Behavioral: music group therapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100875
      • Central University of Finance and Economics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants aged 16 years or older.
• Able to communicate in Mandarin and voluntarily participate in the study.
• Agree to consistently participate in each session.

Exclusion Criteria:

• Disagree to consistently participate in each mindfulness-integrated volleyball course.
• Individuals unable to commit to participating in each mindfulness-integrated volleyball course.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 90 minutes music group therapy	Behavioral: music group therapy; 90 minutes music group therapy
No Intervention: control group; Without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depression	Using GAD-7 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end)， and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
anxiety	Using PHQ-9 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
perceived stress	Using PSS-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep	Using ISI-7 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
positive and negative affective	Using PANAS-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
life satisfaction	Using SWLS-5 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
burnout	Using MBI-SS-15 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
emotion regulation	Using ERQ-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
loneliness and social anxiety	Using UCLA Scale to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
self acceptance	Using SAQ-16 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.
perceived support	Using MSPSS-6 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).	From enrollment to 4 weeks after the end of treatment.

Collaborators and Investigators

• Sponsor: Ye Zhiyin

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): August 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: music therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CUFE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No