NCT06917170

Brief Summary

Interventional Trial (Randomized Experimental Design) Study Goal: This clinical trial aims to evaluate the effectiveness of a structured music therapy program in improving mental health (depression, anxiety, stress) and self-efficacy among college students. Key Questions the Study Aims to Answer: Does music therapy significantly reduce symptoms of depression, anxiety, and stress in college students? Does music therapy significantly enhance self-efficacy in college students? How do improvements in mental health relate to changes in self-efficacy? Study Design: Researchers will compare outcomes between two groups: Experimental Group: Receives a 2-week daily music therapy intervention (1 hour per session) in a controlled environment. Control Group: Does not receive any music therapy intervention during the study period. Participant Activities: Complete pre- and post-intervention assessments using validated scales: Depression-Anxiety-Stress Scale (DASS-21) to measure mental health status. Self-Efficacy Scale to evaluate confidence in personal capabilities. Experimental group participants will: Engage in daily music therapy sessions featuring rhythmically smooth and soothing music selected to promote relaxation. Experience the intervention in a quiet, controlled environment. Control group participants will: Continue their regular routines without any therapeutic intervention. All participants will submit responses via electronic questionnaires (Wenjuanxing platform) to ensure efficient and accurate data collection. Duration: Intervention Period: 2 weeks. Data Collection: Pre-intervention baseline assessment, immediate post-intervention assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

March 25, 2025

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Depression, Anxiety, and Stress Scores

    The assessment was conducted using the simplified version of the Depression Anxiety and Stress Scale. The full scale consists of 21 items, with each of the three subscales (depression, anxiety and stress) containing 7 items. All items are scored on a 4-point scale ranging from "0" (not applicable) to "3" (always applicable). The scores of each subscale are multiplied by 2 to obtain the score of that subscale. The higher the score, the more likely it is to indicate the presence of such emotions.

    2 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Description: Participants in this group do not receive any music therapy intervention during the study period. They continue their regular academic and daily routines. Intervention Type: No intervention.

Music Therapy Intervention Group

EXPERIMENTAL

Description: Participants in this group receive a daily 1-hour music therapy session for 2 weeks. The intervention involves listening to rhythmically smooth, soothing music in a controlled, quiet environment. Music selection is based on evidence supporting its efficacy in reducing stress and enhancing relaxation. Intervention Type: Behavioral (Music Therapy).

Behavioral: Structured Music Therapy Program

Interventions

Description: Content: Participants engage in passive music therapy sessions where they listen to pre-selected music with smooth rhythms and harmonies (e.g., classical, ambient, or instrumental tracks). The music is chosen to align with evidence-based criteria for promoting relaxation and emotional regulation. Frequency: Daily (1 session/day). Duration: 1 hour per session, for a total of 14 sessions over 2 weeks. Setting: Conducted in a quiet, controlled environment to minimize external distractions. Goal: To reduce symptoms of psychological distress (depression, anxiety, stress) and enhance self-efficacy through auditory stimulation and emotional engagement.

Music Therapy Intervention Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be current undergraduate students (from freshmen to seniors), primarily aged between 18 and 25 years old (based on the actual age distribution of the sample).
  • Written informed consent was obtained from all participants prior to their involvement in the study.
  • Participants' baseline mental health status was not excluded (the study did not set strict clinical diagnostic criteria), but they must be able to cooperate with the intervention and complete questionnaires.

You may not qualify if:

  • Participants who are unable to fully participate in the 2-week intervention (such as dropping out midway or taking leave) or who do not complete the pre- and post-intervention questionnaires will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei University of Science and Technology

Xianning, Hubei, 437000, China

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 8, 2025

Study Start

December 1, 2022

Primary Completion

May 1, 2024

Study Completion

October 25, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations