Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-03-01
2025-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study was designed as a randomized clinical trial, comprising a telemedicine intervention group (MT) and a waiting control group (CON group), both of whom were in a state of mental sub-health. The MT group received music therapy, while the Waiting group received the MT intervention after the treatment of the MT group.
The aim of this study was to collect mental health symptom data, behavioral data, and voice expression data using mobile phone, wearable devices (WD) and neuroimaging techniques (fNIRS). These indicators were used as objective measures to assess the long-term and short-term efficacy of telep-sychological interventions. Analyzing digital biomarkers allowed for a deeper understanding of the potential biological and neurobiological mechanisms underlying the effectiveness of tele-psychological interventions.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Music Therapy in Mental Subhealth (EMTMS)
NCT05648539
Effectiveness of Music Therapy on Sleep Disorders
NCT04578860
The Role of Music Therapy in Improving College Students' Mental Health and Self-efficacy
NCT06917170
Evaluation of the Effect of Combined Music on Sleep Disorder
NCT05739773
Music Therapy in Frontline Healthcare Workers
NCT04551274
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants in the MT group will receive 12 sessions, spread over a 3-4 week period, with 3-4 sessions per week, each lasting 20-30 minutes. The MT group will undergo music therapy during the first 4 weeks. Clinical symptom assessments and related data will be collected from participants before MT (baseline) and after MT (at the 3rd or 4th week, 1 month, and 6 months). The MT sessions will be divided into three stages, each focusing on a specific topic: Physical and mental relaxation stage: Participants will learn relaxation techniques encompassing the whole body and mind, including breathing and muscle relaxation. Nature imagination stage: Guided music imagination will be utilized during this stage. Internal self-exploration: Participants will explore positive experiences and potential within themselves, adopting a resource-oriented approach for psychological intervention. Participants in the CON group will not receive any intervention during the treatment of the MT group.
Throughout the study, all participants will undergo symptom assessment, poetry reading, voice collection, functional near-infrared evaluation (fNIRS), and wearable devices monitoring to collect data.
The study aims to achieve the following objectives: Evaluate changes in clinical symptoms, such as depression, anxiety, or insomnia, after the telemedicine MT intervention for individuals experiencing mental sub-health. Gain deeper insights into the possible biological mechanisms underlying the efficacy of tele-MT intervention by analyzing digital biomarkers. Explore the predictive effect of objective biomarkers on the treatment outcomes of tele-MT. The study's ultimate goal is to contribute to the understanding and effectiveness of telemedicine-based MT interventions for individuals facing mental sub-health.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The Clinical Symptom Changes of Music Therapy in a Randomized Controlled Study.
This study investigates the clinical symptom changes of the Music Therapy (MT) group through a randomized controlled trial, aiming to explore the short- and long-term efficacy of MT for individuals experiencing mental sub-health. The study includes one-month and six-month post-treatment follow-ups to assess the lasting effects of MT intervention.
The Online intervention platform
Music Therapy (MT) is known to have a calming effect on individuals by using relaxing and soothing music, gradually inducing a state of relaxation. Moreover, it can effectively regulate individual psychological emotions through its influence on specific brain regions such as the cerebral cortex, hypothalamus, and limbic system. This regulation of emotional responses can lead to an improvement in daily mood, reducing feelings of tension and anxiety.
The changes of objective markers of the music therapy.
This study examines the changes in objective markers resulting from Music Therapy (MT) intervention. It explores alterations in behavior, biological features, and neuroimaging data to understand the potential biological mechanism underlying the efficacy of music therapy. By analyzing these objective markers, the study aims to gain valuable insights into the impact of MT on individuals' mental well-being.
The Online intervention platform
Music Therapy (MT) is known to have a calming effect on individuals by using relaxing and soothing music, gradually inducing a state of relaxation. Moreover, it can effectively regulate individual psychological emotions through its influence on specific brain regions such as the cerebral cortex, hypothalamus, and limbic system. This regulation of emotional responses can lead to an improvement in daily mood, reducing feelings of tension and anxiety.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Online intervention platform
Music Therapy (MT) is known to have a calming effect on individuals by using relaxing and soothing music, gradually inducing a state of relaxation. Moreover, it can effectively regulate individual psychological emotions through its influence on specific brain regions such as the cerebral cortex, hypothalamus, and limbic system. This regulation of emotional responses can lead to an improvement in daily mood, reducing feelings of tension and anxiety.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Participants with a clinician-diagnosed bipolar disorder, substance use disorder, or any psychotic disorder, including schizophrenia, will not be eligible to participate.
3. Individuals who are incapable of understanding or completing study procedures and digital intervention, as determined by the participant, patient/legal guardian, healthcare provider, or clinical research team, will be excluded.
16 Years
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu Province Nanjing Brain Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fei Wang, Ph.D
Role: STUDY_CHAIR
Affiliated Nanjing Brain Hospital, Nanjing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hainan Medical College
Haikou, Hainan, China
Xinxiang Medical University
Xinxiang, Henan, China
Nanjing Medical University
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
81725005-6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.