Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Depression Clinical Trial

Official title:

Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301555
• Other study ID #: db2023
• Status: Completed
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Adai Technology (Beijing) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Reinforcement learning algorithm powered cognitive and behavioral intervention
Reinforcement learning algorithm powered cognitive and behavioral intervention
• cognitive and behavioral intervention
cognitive and behavioral intervention

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Adai Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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