The Effects of Low-Intensity Music in Adolescents With Anxiety
ConditionAnxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorJiangsu Province Nanjing Brain Hospital
About this trial
In modern society, increasing attention has been devoted to mental health problems among adolescents, with anxiety and depressive disorders being particularly prevalent in this population. Evidence indicates that anxiety not only affects emotional states and daily quality of life but also has significant impacts on physiological health, including blood pressure and heart rate. At present, clinical treatment relies primarily on pharmacological interventions and cognitive behavioral therapy; however, these approaches are associated with limitations such as pronounced side effects and delayed onset of efficacy, which restrict their applicability in adolescents. Music and other structured sounds have been used since ancient times to alleviate negative emotional states such as tension and anxiety. Research has shown that listening to soothing music can reduce sympathetic nervous system activity while enhancing parasympathetic tone, thereby leading to a decrease in heart rate and an increase in heart rate variability (HRV). Owing to its gentle characteristics, low-intensity soothing music is considered effective in relieving stress, regulating emotional states, and exerting beneficial effects on physiological indicators.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants experiencing anxiety episodes were adolescents aged 18-25 years with a Generalized Anxiety Disorder-7 (GAD-7) score ≥ 5;
Participants completed self-report symptom assessments via a digital mental health screening platform, alongside the collection of acoustic voice features, heart rate, and functional near-infrared spectroscopy (fNIRS) data;
All participants were required to provide written informed consent;
Disqualifiers
History of major somatic illnesses, particularly those potentially associated with brain tissue alterations, such as hypertension, diabetes, or metastatic tumors; unstable physical conditions, including severe asthma; and a history of neurological abnormalities, including significant head trauma (loss of consciousness lasting more than five minutes), epilepsy, cerebrovascular disease, brain tumors, and neurodegenerative disorders;
Somatic conditions that may induce mood disorder symptoms, such as multiple sclerosis or thyroid disorders;
IQ below 70;
Autism spectrum disorder (ASD) or pervasive developmental disorder (PDD);
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Intensity Soothing Music
Other interventionParticipants will listen to pre-selected low-intensity soothing music under standardized experimental conditions. Anxiety symptoms, and depressive symptoms will be assessed before and after the intervention. In parallel, heart rate variability (HRV) and fNIRS will be recorded to evaluate the short-term clinical effects of the music intervention and to explore its potential neurophysiological mechanisms.
Environmental Sound Exposure
BehavioralParticipants listen to recorded environmental sounds matched in decibel to the music group, for \~15 minutes. Baseline and post-intervention assessments are identical to the music group, including self-report questionnaires, fNIRS, and ECG recordings.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Music Stimulation GroupExperimental treatment 1 intervention
Group B: Environmental Sound Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) after the intervention.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Time frame
Baseline and immediately after the intervention (Day 1)2
Change baseline in anxiety symptoms assessed by the State - Trait Anxiety Inventory (STAI-T; range: 20-80) after the intervention.
Time frame
Baseline and immediately after the intervention (Day 1)Secondary outcomes
1
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) after the intervention.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
Time frame
Baseline and immediately after the intervention (Day 1)2
Change from baseline in the cerebral blood volume (CBV) measured by functional near-infrared spectroscopy(fNIRS) after the intervention.
Participants will undergo fNIRS scans prior to beginning music treatment (baseline) and after completing music treatment (after the intervention). CBV is a fNIRS indicator that reflects the alterations in cerebral blood flow.
Time frame
During the intervention (Day 1)3
Change from baseline in the heart rate variability (HRV) measured by wearable device after the intervention.
Participants will undergo wearable device prior to beginning music treatment (baseline) and after completing music treatment (after the intervention). HRV is a heart indicator that reflects the alterations in autonomic nervous system.
Time frame
Baseline and immediately after the intervention (Day 1)Other outcomes
1
Change from baseline in perceived stress assessed by the Momentary assessment of emotional valence and arousal (range: 1-9) after the intervention.
Effects of the intervention on emotional valence (positive/negative) and arousal.
Time frame
Baseline and immediately after the intervention (Day 1)Sponsors and contacts
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Source ClinicalTrials.gov