UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062553 |
|---|---|
| Receipt number | R000071604 |
| Scientific Title | The effects of lavender aromatherapy and music therapy on sleep quality and depression in college students with subthreshold depression |
| Date of disclosure of the study information | 2026/08/11 |
| Last modified on | 2026/08/11 17:33:42 |
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Basic information
Public title
The effects of lavender aromatherapy and music therapy on sleep quality and depression in college students with subthreshold depression
Acronym
A randomized controlled trial
Scientific Title
The effects of lavender aromatherapy and music therapy on sleep quality and depression in college students with subthreshold depression
Scientific Title:Acronym
None
Region
| Asia(except Japan) |
Condition
Condition
Active
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subthreshold depression is highly prevalent and may increase the risk of developing major depressive disorder in the future. Aromatherapy and music therapy have been used in the treatment of depression; however, their mechanisms of action and their relationship with the gut microbiota remain unclear. This study will combine clinical assessments with gut microbiota testing to systematically analyze the intervention effects of aromatherapy and music therapy on patients with subthreshold depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Study Indicators: Depressive mood;
Secondary Study Indicators: Sleep status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
This study is an exploratory, parallel-design randomized controlled trial. The study will randomly assign 60 participants into two groups using a computer: a control group of 30 cases (Group A) and an aromatherapy combined with music therapy group of 30 cases (Group B). The combined intervention group will receive natural inhalation of aromatic essential oil vapor for 20 minutes, accompanied by music therapy via headphones. The selected music features a gentle and distinctive style, designed to evoke natural scenes, sounds, and scents, creating an atmosphere reminiscent of gardens, mountains, and oceans. Each intervention session will last 20 minutes, conducted 5 times per week, for a total of four weeks. The control group will receive health education lectures. Before the start of the intervention, participants will be asked to sit quietly for 5 minutes. The purpose of this period is to help stabilize their emotional and physiological parameters.Subsequently, they will be required to complete tests and questionnaires, including the recording of basic information (age, gender, medical history, etc.), collection of fecal samples for gut microbiota testing, and completion of the Center for Epidemiologic Studies Depression Scale (CES-D), the Hamilton Depression Rating Scale 24-item version (HAMD-24), and the Pittsburgh Sleep Quality Index (PSQI).
Interventions/Control_2
Regular education
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged over18 years.
Meeting the diagnostic criteria for subthreshold depression, i.e., the presence of depression-related symptoms (such as low mood, diminished interest, changes in sleep or appetite, etc.) for most of the time over the past 2 weeks, but not meeting the diagnostic criteria for Major Depressive Disorder (MDD).
Voluntary participation in this study with signed informed consent; able to cooperate with and complete the prescribed intervention cycle (e.g., music listening + aromatherapy exposure at a fixed daily time slot, and timely participation in follow-up assessments); no contraindications to music listening (such as severe hearing impairment), and no known history of allergy to the selected aromatherapy essential oils (such as lavender, chamomile, and other commonly used intervention essential oils).
Not having participated in other psychological intervention programs or psychotropic drug clinical trials within the past 4 weeks; maintaining a stable daily routine and able to ensure time commitment during the intervention period; able to complete intervention-related operations via smartphone or laboratory equipment (e.g., using specified audio devices and aroma diffusion tools).
Key exclusion criteria
Strong aversion or psychological discomfort toward the type of music used in the study; a documented history of allergy to the essential oil components used in aromatherapy, or the presence of asthma, severe allergic rhinitis, or other conditions that may be exacerbated by aromatic stimulation; physiological barriers that affect the implementation of music therapy, such as hearing disability or severe auditory hypersensitivity.
Having initiated, discontinued, or adjusted antidepressant medication within the past 4 weeks, or having received targeted psychological interventions such as Cognitive Behavioral Therapy (CBT), standalone music therapy, or aromatherapy that may interfere with the evaluation of the combined intervention effect; having acute physical illnesses requiring urgent hospitalization (such as severe cardiovascular or cerebrovascular diseases, immune system diseases) or severe cognitive impairment (such as cognitive impairment related to organic brain lesions).
Other exclusion circumstances: having experienced a major life traumatic event in the recent period (within 3 months) (such as the death of a loved one, a major accident) that may affect emotional state assessment; concurrently participating in other parallel clinical trials or psychological intervention programs; unable to guarantee full participation throughout the intervention and follow-up, or the investigator judges the presence of other factors affecting research quality (such as extremely poor compliance, or insurmountable communication barriers).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Qi |
| Middle name | None |
| Last name | Guo |
Organization
Shanghai University of Medicine and Health Sciences
Division name
Department of rehabilitation
Zip code
201318
Address
Shanghai
TEL
18822002275
1334427886@qq.com
Public contact
Name of contact person
| 1st name | Xiaoyu |
| Middle name | |
| Last name | Chen |
Organization
Shanghai University of Medicine and Health Sciences
Division name
Department of rehabilitation
Zip code
201318
Address
Shanghai
TEL
18961062323
Homepage URL
1334427886@qq.com
Sponsor or person
Institute
Shanghai University of Medicine and Health Sciences
Institute
Department
Personal name
Xiaoyu Chen
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shanghai University of Medicine and Health Sciences
Address
279 ZhouZhu High Road, Pudong New District, Shanghai, 201318, China.
Tel
18961062323
1334427886@qq.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071604
