Clinical Trial: The effects of lavender aromatherapy and music therapy on sleep quality and depression in college students with subthreshold depression (Japan)

Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062553) titled 'The effects of lavender aromatherapy and music therapy on sleep quality and depression in college students with subthreshold depression' on Aug. 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - Shanghai University of Medicine and Health Sciences

Condition: Condition - Active Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

Eligibility: Age-lower limit - 18 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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071604

Disclaimer: Curated by HT Syndication.