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Clinical Trials/NCT06301555
NCT06301555
Completed
Not Applicable

Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Adai Technology (Beijing) Co., Ltd.1 site in 1 country223 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Adai Technology (Beijing) Co., Ltd.
Enrollment
223
Locations
1
Primary Endpoint
GAD7 Response
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

GAD7 Response

Time Frame: Immeidately after intervention

A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline

PHQ9 Response

Time Frame: Immeidately after intervention

A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline

Study Sites (1)

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