Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

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.

Completed

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Reinforcement learning algorithm powered cognitive and behavioral intervention

Behavioral

Reinforcement learning algorithm powered cognitive and behavioral intervention

Cognitive and Behavioral Intervention

Behavioral

cognitive and behavioral intervention

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Adai Technology (Beijing) Co., Ltd.

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 8, 2024
Registry last updated: Mar 8, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed