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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blank Control | No Intervention | No intervention | |
| RL Algorithm Intervention | Experimental |
| |
| No Algorithm Active Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinforcement learning algorithm powered cognitive and behavioral intervention | Behavioral | Reinforcement learning algorithm powered cognitive and behavioral intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| PHQ9 Response | A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline | Immeidately after intervention |
| GAD7 Response | A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline | Immeidately after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of China Medical University | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40610644 | Derived | Shao X, Liu L, Zhu X, Tian C, Li D, Zhang L, Liu X, Liu Y, Zhu G, Li L. Personalized game-based digital intervention for relieving depression and anxiety symptoms: a pilot RCT. Npj Ment Health Res. 2025 Jul 3;4(1):27. doi: 10.1038/s44184-025-00141-x. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| cognitive and behavioral intervention | Behavioral | cognitive and behavioral intervention |
|