NCT06658431

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

January 17, 2025

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

October 20, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

music therapy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • sleep

    From enrollment to 4 weeks after the end of treatment.

  • positive and negative affective

    From enrollment to 4 weeks after the end of treatment.

  • life satisfaction

    From enrollment to 4 weeks after the end of treatment.

  • burnout

    From enrollment to 4 weeks after the end of treatment.

  • emotion regulation

    From enrollment to 4 weeks after the end of treatment.

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

90 minutes music group therapy

Behavioral: music group therapy

control group

NO INTERVENTION

Without any intervention

Interventions

90 minutes music group therapy

Experimental group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central University of Finance and Economics

Beijing, Beijing Municipality, 100875, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 26, 2024

Study Start

October 24, 2024

Primary Completion

August 20, 2025

Study Completion

August 20, 2025

Last Updated

January 17, 2025

Record last verified: 2024-10

Locations