Online Mental Health Interventions for Children and Adolescents (OMHICA)

NCT06238869 | Unknown

• 1 other identifier: 81725005-9
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Anxiety; Stress; Insomnia

Keywords

Computerized Cognitive Behavioral Therapy; Music Therapy; Health education; Acoustic features

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline, week 4 and week 28

• Change from baseline in acoustic features.

  Baseline, week 4 and week 28

Study Arms (4)

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.

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.

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.

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.

Interventions

Computerized Cognitive Behavioral Therapy 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.

Computerized Cognitive Behavioral Therapy (CCBT)

Music Therapy 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.

Music Therapy(MT)

Health education 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.

Health education

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Affiliated Brain Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210024, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Health Education

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Fei Wang, Ph.D

  Nanjing Brain Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: January 26, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)