Online Mental Health Interventions for Children and Adolescents (OMHICA)

NCT ID: NCT06238869

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Depression Anxiety Stress Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Computerized Cognitive Behavioral Therapy (CCBT)

The experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes.

Group Type EXPERIMENTAL

Computerized Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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 Therapy(MT)

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.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type BEHAVIORAL

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 education

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.

Group Type EXPERIMENTAL

Health education

Intervention Type BEHAVIORAL

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.

Blank Control Group

All the participants in this group receive no intervention and undergo only psychological health screenings at designated time points.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computerized Cognitive Behavioral Therapy

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.

Intervention Type BEHAVIORAL

Music Therapy

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.

Intervention Type BEHAVIORAL

Health education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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".

Exclusion Criteria

* 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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu Province Nanjing Brain Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fei Wang, Ph.D

Role: STUDY_CHAIR

Nanjing Brain Hospital, Nanjing Medical University

Locations

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Affiliated Brain Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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81725005-9

Identifier Type: -

Identifier Source: org_study_id

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