Back to resultsEffect of Music Therapy in Depressive Symptoms of Mood Disorder（EMTDSMD）
Primary Purpose
Mood Disorder (Depressive Episodes)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The mini apps named "SOUL GYM" on the Wechat
The mini apps named "SOUL GYM" on the Wechat
The mini apps named "SOUL GYM" on the Wechat
Sponsored by
About this trial
This is an interventional treatment trial for Mood Disorder (Depressive Episodes)
Eligibility Criteria
Inclusion Criteria: Between 13 and 35 years of age; Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (KSADS-PL, patients' age< 18 years old); A current depressive episode defined by HAMD≥7 and Young Mania Rating Scale (YMRS) <12; Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the music treatment phase; Participants and 1 or 2 parents (patients' age< 18 years old) provide informed consent after the detailed description of the study. Exclusion Criteria: • Prior music treatment or standard psychological therapy within 6 months prior to screening; Comorbidity of other DSM-IV axis I disorders or personality disorders; Judged clinically to be at serious suicidal risk; Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities; Unstable medical conditions, e.g., severe asthma; Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases; Mental retardation or autism spectrum disorder; Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants); Current drug/alcohol abuse or dependence; Pregnant or lactating female
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
The clinical response of the MT
The alterations of acoustic features in the MT
The alterations of neuroimaging features in the MT
Arm Description
To assess the efficacy of music therapy of MT group compared to control group in depressive symptoms.
To understand the possible biological mechanism underlying the efficacy of music therapy by analyzing alterations of acoustic features.
To investigate potential neurobiological mechanisms underlying the effectiveness of music therapy by analyzing alterations in neuroimaging features.
Outcomes
Primary Outcome Measures
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 4
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 7 or higher indicate mild, moderate, severe, or very severe depression.
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) at week 4.
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 4
MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4
The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).
Change from baseline in the amplitude of low-frequency fluctuation (ALFF) values measured by resting-state functional magnetic resonance imaging (fMRI) at week 4
Participants will undergo fMRI scans prior to beginning music treatment (baseline) and after completing music treatment (week 4). ALFF is a fMRI indicator that reflects the spontaneous neural activity. After data acquisition, whole-brain voxel-wise analysis of ALFF values will be performed to detect the change from baseline in brain functional activity at baseline and week 4.
Secondary Outcome Measures
Full Information
NCT ID
NCT05879809
First Posted
May 19, 2023
Last Updated
May 19, 2023
Sponsor
Jiangsu Province Nanjing Brain Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05879809
Brief Title
Effect of Music Therapy in Depressive Symptoms of Mood Disorder（EMTDSMD）
Official Title
Effect of Music Therapy in Depressive Symptoms of Mood Disorder: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Nanjing Brain Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Depressive symptom is a common symptom that can be present in various psychiatric conditions, including depression and bipolar disorder. If left untreated, moderate to severe depressive symptoms can lead to serious health complications and are closely linked with suicide. Music therapy (MT)interventions have emerged as an important non-pharmacological approach to treating psychiatric and behavioral disorders, and have been observed to effectively alleviate depressive symptoms. Through its impact on the cerebral cortex, hypothalamus, and limbic system, music helps to regulate an individual's psychological state and can alleviate depressive symptoms.
This study utilized a randomized clinical trial design involving two groups: the MT group and the control group, both of which exhibited depressive symptoms. The MT group received MT in addition to routine clinical treatment, while the control group received only routine clinical treatment. The objective of this study was to demonstrate that MT is an effective intervention for alleviating depressive symptoms and to elucidate the neurobiological mechanisms of MT.
Detailed Description
This study is a double-blind randomized controlled trial aimed at evaluating the effectiveness of MT compared to a control group for major depressive disorder.
Participants will be randomly assigned in a 1:1 ratio to the MT group or control group. All participants will receive 12 sessions (3 sessions per week), each lasting 30 minutes, over a 4-week period. The MT group will receive music therapy during the first 4 weeks, while the control group will receive music therapy during the subsequent 4 weeks (weeks 5-8). Prior to the start of the study (baseline) and after the 4-week intervention, both groups will undergo symptom assessments and brain imaging (MRI) to collect data. The MT intervention consists of three stages, each with a specific focus: 1) physical and mental relaxation, which involves learning relaxation techniques from breathing to muscle relaxation; 2) nature imagination, which includes guided music imagery; and 3) internal self-exploration, which involves identifying positive experiences and potential resources for psychological intervention. The study aims to: 1) assess the clinical efficacy of MT in reducing depressive symptoms, and 2) examine possible biological mechanisms underlying the effectiveness of MT through multidimensional analysis of neuroimaging data and acoustic feature alterations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorder (Depressive Episodes)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The clinical response of the MT
Arm Type
Experimental
Arm Description
To assess the efficacy of music therapy of MT group compared to control group in depressive symptoms.
Arm Title
The alterations of acoustic features in the MT
Arm Type
Experimental
Arm Description
To understand the possible biological mechanism underlying the efficacy of music therapy by analyzing alterations of acoustic features.
Arm Title
The alterations of neuroimaging features in the MT
Arm Type
Experimental
Arm Description
To investigate potential neurobiological mechanisms underlying the effectiveness of music therapy by analyzing alterations in neuroimaging features.
Intervention Type
Device
Intervention Name(s)
The mini apps named "SOUL GYM" on the Wechat
Intervention Description
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The clinical symptoms will be evaluated before and after MT intervention.
Intervention Type
Device
Intervention Name(s)
The mini apps named "SOUL GYM" on the Wechat
Intervention Description
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The acoustic features will be evaluated before and after MT intervention.
Intervention Type
Device
Intervention Name(s)
The mini apps named "SOUL GYM" on the Wechat
Intervention Description
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The neuroimaging features will be evaluated before and after MT intervention.
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4.
Description
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 week 4
Title
Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 4
Description
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 7 or higher indicate mild, moderate, severe, or very severe depression.
Time Frame
Baseline and week 4
Title
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) at week 4.
Description
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Time Frame
Baseline and week 4
Title
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 4
Description
MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.
Time Frame
Baseline and week 4
Title
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4.
Description
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 week 4
Title
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4.
Description
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
Time Frame
Baseline and week 4
Title
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4
Description
The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).
Time Frame
Baseline and week 4
Title
Change from baseline in the amplitude of low-frequency fluctuation (ALFF) values measured by resting-state functional magnetic resonance imaging (fMRI) at week 4
Description
Participants will undergo fMRI scans prior to beginning music treatment (baseline) and after completing music treatment (week 4). ALFF is a fMRI indicator that reflects the spontaneous neural activity. After data acquisition, whole-brain voxel-wise analysis of ALFF values will be performed to detect the change from baseline in brain functional activity at baseline and week 4.
Time Frame
Baseline and week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 13 and 35 years of age;
Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (KSADS-PL, patients' age< 18 years old);
A current depressive episode defined by HAMD≥7 and Young Mania Rating Scale (YMRS) <12;
Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the music treatment phase;
Participants and 1 or 2 parents (patients' age< 18 years old) provide informed consent after the detailed description of the study.
Exclusion Criteria:
• Prior music treatment or standard psychological therapy within 6 months prior to screening;
Comorbidity of other DSM-IV axis I disorders or personality disorders;
Judged clinically to be at serious suicidal risk;
Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;
Unstable medical conditions, e.g., severe asthma;
Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;
Mental retardation or autism spectrum disorder;
Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);
Current drug/alcohol abuse or dependence;
Pregnant or lactating female
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Music Therapy in Depressive Symptoms of Mood Disorder（EMTDSMD）
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