Game-Based Digital Intervention for Depression in Adolescents

NCT06778785 | Active Not Recruiting

• 1 other identifier: pd2402
• Study Type: interventional
• Target: 450
• 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)

• Change from Baseline in Depression on the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8

  HAM-D is a clinician-administered depression assessment scale. To adapt to adolescent participants, item 14 (genital symptoms) was removed. Thus, the score was calculated based on the 16 items. Possible scores range from 0 (no symptoms) to 50 (worst symptom). Change = (Week 8 Score - Baseline Score).

  baseline and immediately after 8-week intervention

• Response Rate - 50 Percent or Greater Reduction in the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8

  HAM-D is a clinician-administered depression assessment scale. To adapt to adolescent participants, item 14 (genital symptoms) was removed. Thus, the score was calculated based on the 16 items. Possible scores range from 0 (no symptoms) to 50 (worst symptom). The response rate was defined as the number of participants with a 50% or greater reduction in HAM-D score from baseline to week 8.

  baseline and immediately after 8-week intervention

Secondary Outcomes (7)

• Change from Baseline in ADHD on the 54-point 18-item ADHD Rating Scale-IV

  baseline and immediately after 8-week intervention

• Change from Baseline in the 7-point Clinical Global Impressions-Severity Scale (CGI-S)

  baseline and immediately after 8-week intervention

• Change from Baseline in the 88-point 22-item Ruminative Responses Scale (RRS)

  baseline and immediately after 8-week intervention

• Change from Baseline in the 35-point 5-item Satisfaction with Life Scale (SWLS)

  baseline and immediately after 8-week intervention

• The 7-point Clinical Global Impressions-Improvement Scale (CGI-I)

  immediately after 8-week intervention

Other Outcomes (3)

• Change from Baseline in Chinese Exam Score at Week 8.

  baseline and immediately after 8-week intervention

• Change from Baseline in Math Exam Score at Week 8.

  baseline and immediately after 8-week intervention

• Change from Baseline in English Exam Score at Week 8.

  baseline and immediately after 8-week intervention

Study Arms (3)

Personalized Digital Intervention (Smartphone App-based)

EXPERIMENTAL

Behavioral: Digital Intervention; Other: Personalization Algorithm

Health Education Placebo (Smartphone App-based)

PLACEBO COMPARATOR

Behavioral: Health Education

Non-personalized Digital Intervention (Smartphone App-based)

ACTIVE COMPARATOR

Behavioral: Digital Intervention

Interventions

Digital Intervention BEHAVIORAL

game-based digital intervention app

Non-personalized Digital Intervention (Smartphone App-based); Personalized Digital Intervention (Smartphone App-based)

Health Education BEHAVIORAL

traditional health education app

Health Education Placebo (Smartphone App-based)

Personalization Algorithm OTHER

a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime

Personalized Digital Intervention (Smartphone App-based)

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).
• no prior use of antidepressants or antipsychotic medications.
• having a HAMD (Hamilton Depression scale) score \>= 8 upon enrollment
• demonstrate normal cognitive function.
• voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.
• being able to read and typeset Chinese.

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)
• at high risk of suicide

Sponsors & Collaborators

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

Study Sites (1)

West China Hospital

Chengdu, Sichuang, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

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: January 12, 2025
• First Posted: January 16, 2025
• Study Start: April 17, 2024
• Primary Completion: December 30, 2024
• Study Completion: July 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

CN (1)