DepressionNCT06238869
Online Mental Health Interventions for Children and Adolescents (OMHICA)
A study testing Computerized Cognitive Behavioral Therapy, Music Therapy and Health education in people with Depression and Anxiety, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial summary
Mental health has become an increasing concern, especially among children and adolescents in schools. However, not all individuals in mental suboptimal states require pharmacological treatment. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Computerized Cognitive Behavioral Therapy, Music Therapy and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Willing elementary students, with parental consent, to undergo mental health screenings and engage in subsequent mental health activities.
- Ages between 11 and 19.
- Participants who can operate a mobile phone and can read and receive messages on "WeChat".
Who cannot join
- Participants with self-reported lifetime suicide attempts, active self-harm, or active suicidal ideation with intent will be excluded from the study.
- Have a diagnosis by a clinician of bipolar disorder, substance use disorder, or any psychotic disorder including schizophrenia
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Brain Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210024
About this study
Official title: Multi-faceted Online Interventions to Promoting Mental Health in Children and Adolescents:a Population-based, Cluster-randomized Controlled Trial
Mental health has become an increasing concern, especially among children and adolescents in schools. However, not all individuals in mental suboptimal states require pharmacological treatment. With the development of internet technology, internet-based psychological therapy methods are considered to have tremendous potential and are being given significant attention. Simultaneously, due to their convenience, these approaches are widely applied. Computerized Cognitive Behavioral Therapy (CCBT) can achieve its therapeutic effect by improving activation patterns of the brain's internal networks to promote self-regulation. Music Therapy (MT) can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety. Health Education works to provide parents with knowledge and information about mental health, aiming to help them better understand and support their own and their children's mental health, thereby improving parent-child relationships.
The study was designed as a randomized clinical trial with four groups, the CCBT group, the MT group, the Health Education group and the control group in children and adolescent .The CCBT group, the MT group, and the Health Education group all completed their interventions through online self-help therapy. The control group did not receive any intervention. Data collection was conducted by trained, certified and qualified personnel.
The mental health intervention is a crucial component of the "School-based Evaluation Advancing Response for Child Health (SEARCH)" cohort study, focusing on observing changes in the population undergoing the intervention within the cohort study.
Read the detailed description
The online intervention study was a population-based, cluster-randomized controlled trial that aimed to evaluate the efficacy of various interventions promoting mental health in children and adolescent.
The CCBT intervention consisted of two components: (a) The participants were presented with 12 modules. All modules were based on the cognitive- behavioral model by Beck and informed by the updated procedures by J. Beck and Wright. Modules 1-2 introduce the definitions, symptoms, causes and basic cognitive models of depression and anxiety. Modules 3-6 describe how to identify cognitive distortions and deal with negative automatic thoughts in daily life. Modules 7-8 mainly focus on behavioral activation and dealing with intermediate beliefs. Modules 9-11 center on learning about structured problem-solving approaches and core beliefs. Module 12 describes a summary of treatment and relapse prevention. (b) After each module is completed, we send a notification of homework to the subjects, and their compliance is assessed by registering completed modules and homework. The experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes.
All the participants of Music Therapy will be treated with 12 sessions (3 sessions per week),15 minutes each time, and conducted for 4 weeks. The MT is mainly divided into three stages, and each stage has a topic. The topic of each stage as follow: physical and mental relaxation stage: learning the whole body and mind relaxation mode from breathing to muscle; nature imagination stage: guiding music imagination; internal self-exploration: excavating the positive experience and positive potential of the listener and adopting resource orientation for psychological intervention.
The health education group will conduct a series of mental health lectures through the WeChat Mini Program on a weekly basis, with each session lasting for 30 minutes, spanning over a duration of four weeks. The themes of mental health lectures were:1.Parents communicate well with their children, and they thrive in the sun;2.Three effective increments in the growth of adolescents;3.early identification and intervention of adolescent emotional disorders;4.brain and emotions. While the control group did not receive any intervention during the same time.
- Conditions
- Depression, Anxiety, Stress, Insomnia
- Being tested
- Computerized Cognitive Behavioral Therapy, Music Therapy, Health education
- Keywords
- Computerized Cognitive Behavioral Therapy, Music Therapy, Health education, Acoustic features
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Behavioral TherapyBehavioural
CCBT (Computerized Cognitive Behavioral Therapy) is a unique approach to improving mental well-being. It utilizes computer-based cognitive and behavioral techniques to induce relaxation and regulate emotional responses by targeting specific brain regions. CCBT offers interactive and personalized interventions, empowering individuals to address mental health challenges like depression and anxiety. Its convenience and accessibility through digital platforms make it a practical choice for enhancing emotional well-being.
Music TherapyBehavioural
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety.
Health educationBehavioural
Health education focuses on providing insights into adolescent mental health, offering practical coping strategies and behavior patterns. It emphasizes the crucial link between parental guidance and the well-being of adolescents. By fostering healthier psychological interactions, it cultivates an environment supportive of adolescent mental health, strengthens family support, and promotes comprehensive development in physical, mental, and cognitive aspects.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Behavioral Therapy (CCBT) | Experimental | The experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes. Receives: Behavioral: Computerized Cognitive Behavioral Therapy |
| Music Therapy(MT) | Experimental | All the participants of Music Therapy will be treated with 12 sessions (3 sessions per week),15 minutes each time, and conducted for 4 weeks. Receives: Behavioral: Music Therapy |
| Health education | Experimental | The health education group will conduct a series of mental health lectures through the WeChat Mini Program on a weekly basis, with each session lasting for 30 minutes, spanning over a duration of four weeks. Receives: Behavioral: Health education |
| Blank Control Group | No intervention | All the participants in this group receive no intervention and undergo only psychological health screenings at designated time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DASS-depression detection rate
Change from baseline in the screening rate of depressive symptoms assessed by The Depression Anxiety Stress Scale within the population.
Measured: Baseline, week 4 and week 28
Change from baseline in DASS-anxiety detection rate
Change from baseline in the screening rate of anxiety symptoms assessed by The Depression Anxiety Stress Scale within the population.
Measured: Baseline, week 4 and week 28
Change from baseline in DASS-stress detection rate
Change from baseline in the screening rate of stress symptoms assessed by The Depression Anxiety Stress Scale within the population.
Measured: Baseline, week 4 and week 28
Change from baseline in Insomnia Severity Index (ISI) questionnaire insomnia detection rate
Insomnia Severity Index (ISI) questionnaire insomnia detection rate refers to the rate at which insomnia is identified or detected based on responses from the ISI questionnaire. The ISI is a validated tool used to assess insomnia symptom severity and their impact on daily functioning. The detection rate indicates the proportion of individuals in a population or sample whose ISI questionnaire responses indicate the presence of insomnia.
Measured: Baseline, week 4 and week 28
Secondary outcomes (14)
Change from baseline in depressive symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.
The DASS Depression scale, with scores ranging from 0 to 42, is interpreted as follows for different severity levels of depression: normal (0-9), mild (10-13), moderate (14-20), severe (21-27), and extremely severe (28+).
Measured: Baseline, week 4 and week 28
Change from baseline in anxiety symptom assessed by The Depression, Anxiety and Stress Scale (DASS)at week 4, week 8, and week 28. Stress Scale (DASS) at week 4, week 8, and week 28.
The DASS Anxiety scale, also with scores ranging from 0 to 42, has the following grading criteria: normal (0-7), mild (8-9), moderate (10-14), severe (15-19), and extremely severe (20+).
Measured: Baseline, week 4 and week 28
Change from baseline in stress symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.
The DASS Stress scale, which also has scores ranging from 0 to 42, the grading criteria are as follows: normal (0-14), mild (15-18), moderate (19-25), severe (26-33), and extremely severe (34+).
Measured: Baseline, week 4 and week 28
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4, week 8, and week 28.
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
Measured: Baseline, week 4 and week 28
Change from baseline in acoustic features.
Participants will record videos prior to beginning intervention (baseline) and after completing intervention (week 4, week 8, and week 28). Participants read the poem "The North Wind and the Sun" in a quiet environment and recorded it to obtain the voice snippets. Acoustic features are a set of indicators that can reflect an individual's emotional state. The indicators include LOGenergy, zero-crossing rate, fband, spectralRollOff, melspec spectral flux, centroid, maxPos, minPos mfcc, voiceProb F0, F0env etc.
Measured: Baseline, week 4 and week 28
Change from baseline in the facial expression features measured.
Participants will record audio prior to beginning intervention (baseline) and after completing intervention (week 4, week 8 and week 28). Participants were given a series of dynamic facial expressions by answering short on-screen questions and tapping a record video button on the screen. Facial features are a set of indicators that can reflect an individual's emotional state, including eye characteristics, facial action unit, head features, deformation shape parameter. Previous studies have found that the more severe the depressive symptoms, the sadder the expression and the less the patient smiles. As depressed mood improves, depressed expressions and the patient's range of body movements can improve accordingly.
Measured: Baseline and week 28
Change from baseline in the Strengths and Difficulties Situation assessed by Strengths and Difficulties Questionnaire (SDQ).
SDQ includes five scales of five items each: emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. Each subscale comprises 5 questions with response options of 0,1, and 2 points. The score range for each subscale is from 0 to 10 points. A higher score on each subscale indicates more severe issues in that particular aspect.
Measured: Baseline and week 28
Change from baseline in resting-state magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and structural (T1-weighted) imaging at baseline and week 4
Participants will undergo MRI scans before (week 0) and after completing (week 4) the treatment. This allows for a comprehensive examination of changes in functional activity, DTI and structural changes in the brain between baseline and weeks 4.
Measured: Baseline and week 4
Change in the influence of the family environment on the individual, as assessed by the Family Environment Scale (FES), from baseline to week 4 and week 28.
The FES scale has seven factors, which are intimacy, conflict, success, culture, entertainment, organization, control, and these 7 dimensions measure the influence of family on individuals.
Measured: Baseline and week 28
The change from baseline in internet addiction symptom was assessed by the Internet Addiction Scale at week 4 and week 28.
The Internet Addiction Scale has five factors, namely compulsive Internet use, Internet addiction withdrawal reaction, Internet addiction tolerance, time management problems, interpersonal and health problems. The higher the total score, the deeper the degree of Internet addiction.
Measured: Baseline and week 28
The change from baseline in the implementation of NSSI behaviors was assessed by Ottawa Self-injury Inventory (OSI) at week 4 and week 28.
OSI is used to assess the prevalence of NSSI, including the frequency, concealment and reasons for NSSI.
Measured: Baseline and week 28
The change from baseline in the victimization of bullying since enrollment was assessed by Delaware Bullying Victimization Scale (DBVS) at week 4 and week 28.
DBVS was used to assess the bullying behaviors, including physical bullying, relational bullying, verbal bullying and cyberbullying. The total scale score is the sum of the item scores, with higher total scores indicating more severe bullying.
Measured: Baseline and week 28
The change from baseline in childhood traumatic experiences was assessed by Childhood Trauma Questionnaire-28 item Short Form(CTQ-SF) at week 4 and week 28.
CTQ-SF contained four factors: emotional abuse, physical abuse, emotional neglect and physical neglect. Emotional neglect ≥15, physical neglect ≥10, emotional abuse ≥13, and physical abuse ≥10.
Measured: Baseline and week 28
The change from baseline in food addiction symptom was assessed by Modified Yale Food Addiction Scale (mYFAS) at week 4 and week 28.
The mYFAS is used to assess food addiction symptoms for diet-related impairment and distress. The scale is assessed on an 8-point scale ranging from 0 (never) to 7 (daily).
Measured: Baseline and week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start26 Jan 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Wang, Ph.D, Study chair, The Affiliated Brain Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238869
- Sponsor's protocol ID
- 81725005-9
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-faceted Online Interventions to Promoting Mental Health in Children and Adolescents:a Population-based, Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06238869
- Acronym / sponsor ID
- 81725005-9
- Conditions
- Depression, Anxiety, Stress, Insomnia
- Keywords
- Computerized Cognitive Behavioral Therapy, Music Therapy, Health education, Acoustic features
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mental health has become an increasing concern, especially among children and adolescents in schools. However, not all individuals in mental suboptimal states require pharmacological treatment. With the development of internet technology, internet-based psychological therapy methods are considered to have tremendous potential and are being given significant attention. Simultaneously, due to their convenience, these approaches are widely applied. Computerized Cognitive Behavioral Therapy (CCBT) can achieve its therapeutic effect by improving activation patterns of the brain's internal networks to promote self-regulation. Music Therapy (MT) can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety. Health Education works to provide parents with knowledge and information about mental health, aiming to help them better understand and support their own and their children's mental health, thereby improving parent-child relationships.
The study was designed as a randomized clinical trial with four groups, the CCBT group, the MT group, the Health Education group and the control group in children and adolescent .The CCBT group, the MT group, and the Health Education group all completed their interventions through online self-help therapy. The control group did not receive any intervention. Data collection was conducted by trained, certified and qualified personnel.
The mental health intervention is a crucial component of the "School-based Evaluation Advancing Response for Child Health (SEARCH)" cohort study, focusing on observing changes in the population undergoing the intervention within the cohort study.
Detailed description
The online intervention study was a population-based, cluster-randomized controlled trial that aimed to evaluate the efficacy of various interventions promoting mental health in children and adolescent.
The CCBT intervention consisted of two components: (a) The participants were presented with 12 modules. All modules were based on the cognitive- behavioral model by Beck and informed by the updated procedures by J. Beck and Wright. Modules 1-2 introduce the definitions, symptoms, causes and basic cognitive models of depression and anxiety. Modules 3-6 describe how to identify cognitive distortions and deal with negative automatic thoughts in daily life. Modules 7-8 mainly focus on behavioral activation and dealing with intermediate beliefs. Modules 9-11 center on learning about structured problem-solving approaches and core beliefs. Module 12 describes a summary of treatment and relapse prevention. (b) After each module is completed, we send a notification of homework to the subjects, and their compliance is assessed by registering completed modules and homework. The experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes.
All the participants of Music Therapy will be treated with 12 sessions (3 sessions per week),15 minutes each time, and conducted for 4 weeks. The MT is mainly divided into three stages, and each stage has a topic. The topic of each stage as follow: physical and mental relaxation stage: learning the whole body and mind relaxation mode from breathing to muscle; nature imagination stage: guiding music imagination; internal self-exploration: excavating the positive experience and positive potential of the listener and adopting resource orientation for psychological intervention.
The health education group will conduct a series of mental health lectures through the WeChat Mini Program on a weekly basis, with each session lasting for 30 minutes, spanning over a duration of four weeks. The themes of mental health lectures were:1.Parents communicate well with their children, and they thrive in the sun;2.Three effective increments in the growth of adolescents;3.early identification and intervention of adolescent emotional disorders;4.brain and emotions. While the control group did not receive any intervention during the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Behavioral Therapy (CCBT) | Experimental | Behavioral: Computerized Cognitive Behavioral TherapyThe experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes. |
| Music Therapy(MT) | Experimental | Behavioral: Music TherapyAll the participants of Music Therapy will be treated with 12 sessions (3 sessions per week),15 minutes each time, and conducted for 4 weeks. |
| Health education | Experimental | Behavioral: Health educationThe health education group will conduct a series of mental health lectures through the WeChat Mini Program on a weekly basis, with each session lasting for 30 minutes, spanning over a duration of four weeks. |
| Blank Control Group | No intervention | –All the participants in this group receive no intervention and undergo only psychological health screenings at designated time points. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Willing elementary students, with parental consent, to undergo mental health screenings and engage in subsequent mental health activities.
- Ages between 11 and 19.
- Participants who can operate a mobile phone and can read and receive messages on "WeChat".
Key exclusion criteria (3 listed)
- Participants with self-reported lifetime suicide attempts, active self-harm, or active suicidal ideation with intent will be excluded from the study.
- Have a diagnosis by a clinician of bipolar disorder, substance use disorder, or any psychotic disorder including schizophrenia
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive Behavioral TherapyCCBT (Computerized Cognitive Behavioral Therapy) is a unique approach to improving mental well-being. It utilizes computer-based cognitive and behavioral techniques to induce relaxation and regulate emotional responses by targeting specific brain regions. CCBT offers interactive and personalized interventions, empowering individuals to address mental health challenges like depression and anxiety. Its convenience and accessibility through digital platforms make it a practical choice for enhancing emotional well-being. | Behavioural | Computerized Cognitive Behavioral Therapy (CCBT) |
| Music TherapyMusic Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety. | Behavioural | Music Therapy(MT) |
| Health educationHealth education focuses on providing insights into adolescent mental health, offering practical coping strategies and behavior patterns. It emphasizes the crucial link between parental guidance and the well-being of adolescents. By fostering healthier psychological interactions, it cultivates an environment supportive of adolescent mental health, strengthens family support, and promotes comprehensive development in physical, mental, and cognitive aspects. | Behavioural | Health education |
Primary outcome
Change from baseline in DASS-depression detection rate
Time frame: Baseline, week 4 and week 28
Change from baseline in the screening rate of depressive symptoms assessed by The Depression Anxiety Stress Scale within the population.
Change from baseline in DASS-anxiety detection rate
Time frame: Baseline, week 4 and week 28
Change from baseline in the screening rate of anxiety symptoms assessed by The Depression Anxiety Stress Scale within the population.
Change from baseline in DASS-stress detection rate
Time frame: Baseline, week 4 and week 28
Change from baseline in the screening rate of stress symptoms assessed by The Depression Anxiety Stress Scale within the population.
Change from baseline in Insomnia Severity Index (ISI) questionnaire insomnia detection rate
Time frame: Baseline, week 4 and week 28
Insomnia Severity Index (ISI) questionnaire insomnia detection rate refers to the rate at which insomnia is identified or detected based on responses from the ISI questionnaire. The ISI is a validated tool used to assess insomnia symptom severity and their impact on daily functioning. The detection rate indicates the proportion of individuals in a population or sample whose ISI questionnaire responses indicate the presence of insomnia.
14 secondary outcomes
Change from baseline in depressive symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.
Time frame: Baseline, week 4 and week 28
Change from baseline in anxiety symptom assessed by The Depression, Anxiety and Stress Scale (DASS)at week 4, week 8, and week 28. Stress Scale (DASS) at week 4, week 8, and week 28.
Time frame: Baseline, week 4 and week 28
Change from baseline in stress symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.
Time frame: Baseline, week 4 and week 28
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4, week 8, and week 28.
Time frame: Baseline, week 4 and week 28
Change from baseline in acoustic features.
Time frame: Baseline, week 4 and week 28
Change from baseline in the facial expression features measured.
Time frame: Baseline and week 28
Change from baseline in the Strengths and Difficulties Situation assessed by Strengths and Difficulties Questionnaire (SDQ).
Time frame: Baseline and week 28
Change from baseline in resting-state magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and structural (T1-weighted) imaging at baseline and week 4
Time frame: Baseline and week 4
Change in the influence of the family environment on the individual, as assessed by the Family Environment Scale (FES), from baseline to week 4 and week 28.
Time frame: Baseline and week 28
The change from baseline in internet addiction symptom was assessed by the Internet Addiction Scale at week 4 and week 28.
Time frame: Baseline and week 28
The change from baseline in the implementation of NSSI behaviors was assessed by Ottawa Self-injury Inventory (OSI) at week 4 and week 28.
Time frame: Baseline and week 28
The change from baseline in the victimization of bullying since enrollment was assessed by Delaware Bullying Victimization Scale (DBVS) at week 4 and week 28.
Time frame: Baseline and week 28
The change from baseline in childhood traumatic experiences was assessed by Childhood Trauma Questionnaire-28 item Short Form(CTQ-SF) at week 4 and week 28.
Time frame: Baseline and week 28
The change from baseline in food addiction symptom was assessed by Modified Yale Food Addiction Scale (mYFAS) at week 4 and week 28.
Time frame: Baseline and week 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Wang, Ph.D study chair
The Affiliated Brain Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Behavioral Therapy, Music Therapy and Health education in people with Depression and Anxiety, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in DASS-depression detection rate (time frame: Baseline, week 4 and week 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.