Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Adai Technology

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: cognitive and behavioral intervention; Behavioral: Reinforcement learning algorithm powered cognitive and behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06301555

db2023

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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223 participants in 3 patient groups

Blank Control

No Intervention group

Description:

No intervention

RL Algorithm Intervention

Experimental group

Treatment:

Behavioral: Reinforcement learning algorithm powered cognitive and behavioral intervention

No Algorithm Active Control

Active Comparator group

Treatment:

Behavioral: cognitive and behavioral intervention