Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Not Applicable

Completed

• Conditions: Anxiety; Depression

• Registration Number: NCT06301555
• Lead Sponsor: Adai Technology (Beijing) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GAD7 Response	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	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

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China