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Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06301555
Enrollment
223
Registered
2024-03-08
Start date
2023-11-01
Completion date
2024-02-01
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Brief summary

Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined.

Interventions

BEHAVIORALReinforcement learning algorithm powered cognitive and behavioral intervention

Reinforcement learning algorithm powered cognitive and behavioral intervention

cognitive and behavioral intervention

Sponsors

Adai Technology (Beijing) Co., Ltd.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. age between 18 and 60 years; 2. having a PHQ-9 score or a GAD-7 score upon enrollment; 3. being able to operate a smartphone fluently; 4. having normal vision after correction

Exclusion criteria

1. clinical diagnoses of severe psychiatric conditions such as schizophrenia or bipolar disorder; 2. at high risk of suicide or self-harm; 3. having significant cognitive impairments; 4. active substance abuse or dependence; 5. currently undergoing other psychological or pharmacological treatments for depression or anxiety; 6. pregnant individuals or those with postpartum depression, and those with serious physical health conditions that could impact mental health.

Design outcomes

Primary

MeasureTime frameDescription
PHQ9 ResponseImmeidately after interventionA user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline
GAD7 ResponseImmeidately after interventionA user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026