Digital Intervention for Depression and Anxiety in Adolescents

NCT06349993 | Recruiting

• 1 other identifier: pd003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy. Participants will be asked to engage with the digital intervention platform for a period of two months.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale

  Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.

  baseline and immediately after 8-week intervention

• Hamilton Anxiety Rating Scale

  Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms.

  baseline and immediately after 8-week intervention

Secondary Outcomes (3)

• ADHD(attention deficit hyperactivity disorder) Rating Scale-IV

  baseline and immediately after 8-week intervention

• PHQ-9 (Patient Health Questionnaire-9)

  baseline and weekly assessments during the treatment period, assessed up to 8 weeks

• GAD-7 (Generalized Anxiety Disorder-7)

  baseline and weekly assessments during the treatment period, assessed up to 8 weeks

Study Arms (2)

Digital Intervention

EXPERIMENTAL

Behavioral: Digital Intervention

Health Education

ACTIVE COMPARATOR

Behavioral: Health Education

Interventions

Digital Intervention BEHAVIORAL

game-based digital intervention app

Digital Intervention

Health Education BEHAVIORAL

traditional health education app

Health Education

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
• having a HAMD(Hamilton Depression scale) score upon enrollment
• demonstrate normal cognitive function.
• voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.

You may not qualify if:

• with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning
• with concurrent psychiatric disorders (as determined by clinical assessment)
• with concurrent psychiatric disorders (as determined by the assessing clinician)
• at high risk of suicide

Sponsors & Collaborators

• Adai Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuang, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Liqun Zhang

CONTACT

010-85795371; zhangliqun@adai-tech.com

Study Design

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

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 5, 2024
• Study Start: April 17, 2024
• Primary Completion: December 30, 2024
• Study Completion: July 1, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

CN (1)