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Active, Not Recruiting

NCT Number: NCT06778785

Game-Based Digital Intervention for Depression in Adolescents

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Digital Intervention

Behavioral

game-based digital intervention app

Health Education

Behavioral

traditional health education app

Personalization Algorithm

Other

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

Primary outcomes

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

    Time frame: baseline and immediately after 8-week intervention

    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).

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

    Time frame: baseline and immediately after 8-week intervention

    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.

Secondary outcomes

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

    Time frame: baseline and immediately after 8-week intervention

    ADHD RS IV is a clinician-administered ADHD assessment scale. Possible scores range from 0 (no symptoms) to 50 (worst symptom). Change = (Week 8 Score - Baseline Score).

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

    Time frame: baseline and immediately after 8-week intervention

    CGI-S is a clinician-administered symptom severity scale. Possible scores range from 1 (least severe) to 7 (most severe). Change = (Week 8 Score - Baseline Score).

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

    Time frame: baseline and immediately after 8-week intervention

    Rumination is the process of compulsively focused attention on the symptoms of one's distress, and on its possible causes and consequences, as opposed to its solutions. RRS is a self-report scale that measures rumination. Possible scores range from 22 (least ruminative symptoms) to 88 (worst ruminative symptoms). Change = (Week 8 Score - Baseline Score).

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

    Time frame: baseline and immediately after 8-week intervention

    The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. Possible scores range from 5 (lowest satisfaction) to 35 (highest satisfaction). Change = (Week 8 Score - Baseline Score).

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

    Time frame: immediately after 8-week intervention

    CGI-S is a clinician-administered total improvement scale. Possible scores range from 1 (very much improved) to 7 (Very much worse).

  6. Change from Baseline in Anxiety on the 52-point 13-item Hamilton Anxiety Rating Scale (HAM-A) at Week 8

    Time frame: baseline and immediately after 8-week intervention

    HAM-A is a clinician-administered anxiety assessment scale. To adapt to adolescent participants, item 12 (genitourinary symptoms) was removed. Thus, the score was calculated based on the 13 items. Possible scores range from 0 (no symptoms) to 52 (worst symptom). Change = (Week 8 Score - Baseline Score).

  7. Response Rate - 50 Percent or Greater Reduction in the 52-point 13-item Hamilton Anxiety Rating Scale (HAM-A) at Week 8

    Time frame: baseline and immediately after 8-week intervention

    HAM-A is a clinician-administered anxiety assessment scale. To adapt to adolescent participants, item 12 (genitourinary symptoms) was removed. Thus, the score was calculated based on the 13 items. Possible scores range from 0 (no symptoms) to 52 (worst symptom). Change = (Week 8 Score - Baseline Score). 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.

Other outcomes

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

    Time frame: baseline and immediately after 8-week intervention

    The Chinese exam score was obtained by asking the participants the score (standardized to a 100-point scale) of their most recent exam on the subject of Chinese taken at school. Possible scores range from 0 (worst academic performance) to 100 (best academic performance). Change = (Week 8 Score - Baseline Score).

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

    Time frame: baseline and immediately after 8-week intervention

    The Math exam score was obtained by asking the participants the score (standardized to a 100-point scale) of their most recent exam on the subject of Math taken at school. Possible scores range from 0 (worst academic performance) to 100 (best academic performance). Change = (Week 8 Score - Baseline Score).

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

    Time frame: baseline and immediately after 8-week intervention

    The English exam score was obtained by asking the participants the score (standardized to a 100-point scale) of their most recent exam on the subject of English taken at school. Possible scores range from 0 (worst academic performance) to 100 (best academic performance). Change = (Week 8 Score - Baseline Score).

Sponsors and collaborators

Lead sponsor

Adai Technology (Beijing) Co., Ltd.

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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